Sleep Disorder; Breathing-RelatedPhase 4MIST+NCT05382494
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children
A Phase 4 study testing Mometasone Furoate 50mcg Nasal Spray and Sodium Chloride 0.9 % Nasal Spray in people with Sleep Disorder; Breathing-Related and Snoring, run by Murdoch Childrens Research Institute at 2 sites in Australia.
Trial summary
MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Sleep Disorder; Breathing-Related, Snoring, Obstructive Sleep Apnea of Child
- What is being tested?
- Mometasone Furoate 50mcg Nasal Spray and Sodium Chloride 0.9 % Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesAustralia
- Study dates
- 5 Dec 2022to 17 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Each participant must meet all of the following criteria to be enrolled in this trial:
- Is between the ages of 3 and 12 years inclusive at the time of randomisation
- Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the study:
- Has a BMI over the 97th centile for age and gender
- Has a history of tonsillectomy and/or adenoidectomy
- Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
- Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
- Has a history of nasal surgery or trauma which has not fully healed
Show all 15Show fewer
- Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
- Is assessed to have stertor (snoring) while awake at rest
- Has a known hypersensitivity to the study drug or its formulation
- Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
- Daily use of antihistamine or decongestant nasal sprays
- Is known to require systemic steroids prior to the completion of the study treatment phase
- Has had treatment with any other investigational drug within 6 months prior to randomisation
- Is unable to provide consent without the aid of an interpreter.
- In the opinion of the Investigator may be unable to follow the protocol
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Monash Children's Hospital
Clayton, Victoria, 3168
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, 3052
About this study
Official title: Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial
MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.
Read the detailed description
MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.
- Conditions
- Sleep Disorder; Breathing-Related, Snoring, Obstructive Sleep Apnea of Child, Sleep Disorders in Children, Tonsillar Hypertrophy, Adenoidal Disorder
- Being tested
- Mometasone Furoate 50mcg Nasal Spray, Sodium Chloride 0.9 % Nasal Spray
- Medical subject headings
- Sleep Wake Disorders, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate 50mcg Nasal SprayDrug
Also called Sensease Nasal Allergy Relief Nasal Spray
Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks
Sodium Chloride 0.9 % Nasal SprayDrug
Also called Intranasal Saline Spray
Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Steroids | Experimental | Not described Receives: Drug: Mometasone Furoate 50mcg Nasal Spray |
| Intranasal Saline | Placebo comparator | Not described Receives: Drug: Sodium Chloride 0.9 % Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 6 weeks
Secondary outcomes (35)
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 12 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 12 weeks
An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)
The Pediatric Sleep Questionnaire - sleep disordered breathing subscale is a validated questionnaire which contains 22 symptom items that ask about snoring frequency, loud snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behaviour, and other paediatric Obstructive Sleep Apnoea (OSA) features. Responses are "yes" = 1, "no" = 0, and "don't know"=missing.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Measured: 6 weeks
An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).
The Obstructive Sleep Apnoea-18 (OSA-18) questionnaire is a validated questionnaire and consists of 18 questions concerning sleep disturbances, physical symptoms, emotional distress, daytime function, and caregiver concerns.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Measured: 6 weeks
An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Measured: 6 weeks
An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
The Strengths and Difficulties Questionnaire (SDQ) is a validated brief behavioural screening questionnaire about 3-16 year olds. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Measured: 6 weeks
An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
The Glasgow Children's Benefit Inventory (GCBI) consists of 24 questions on the consequences of a specified intervention on various aspects of the day-to-day child life, without reference to any specific symptoms, and it can be apply to children of any age. The mean scores and 95% confidence intervals (CIs) in the two treatment arms will be calculated and the treatment arms will be compared using a linear regression adjusted for centre.
Measured: 6 weeks
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T\&A)?"
Measured: 6 weeks
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T\&A)?"
Measured: 12 weeks
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "Do you think your child needs surgery to remove their tonsils or adenoids (T\&A)?"
Measured: 6 months
Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study. "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Measured: 6 weeks
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Measured: 12 weeks
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Measured: 6 months
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "If T\&A surgery were recommended to you now, would you be happy to proceed?"
Measured: 12 months
Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Measured: 6 weeks
Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Measured: 12 weeks
Proportion of parents who think their child still needs a review by a hospital specialist at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Measured: 6 months
Proportion of parents who think their child still needs a review by a hospital specialist at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Do you think your child's symptoms need review by a hospital specialist?"
Measured: 12 months
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Measured: 6 weeks
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Measured: 12 weeks
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Measured: 6 months
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months
This will be measured by asking parents the following question on a parent assessment questionnaire developed for the study: "Would you be happy to have your child taken off the hospital clinic waiting list?"
Measured: 12 months
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Measured: 6 weeks
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)
A study specific questionnaire using a 5 point Likert Scale will be used to evaluate parent satisfaction of ease of administration of drug, effectiveness of treatment, side effects. A higher score will indicate higher satisfaction. The mean scores and 95% confidence intervals in the two arms will be calculated and the treatment arms will compared using a linear regression adjusted for center.
Measured: 12 weeks
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months
Parents will be contacted by email with a short survey to record whether their child is either on a waitlist for ENT surgery or has undergone ENT surgery.
The proportion of participants in each treatment arm who have progressed to Tonsillectomy and/or Adenoidectomy for SDB will be calculated with 95% confidence intervals. The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 12 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity.
The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 12 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 6 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months
The Pediatric Quality of Life Inventory (PedsQL) is a validated, standardised, generic assessment instrument that provides a modular approach to measure health related quality of life in healthy children and adolescents and those with acute and chronic disorders. This questionnaire consists of 23 items evaluating physical, emotional, social and scholastic functioning, and it integrates both generic core scales and disease-specific modules.
The proportion of participants in each treatment arm with resolution of symptoms at 12 months will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
Measured: 12 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months
Parents will be emailed a survey with the following questions about any treatment their child may have had for SDB
- Specialty of Dr seen and number of appointments
- Medical Treatment used, and duration of treatment The study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm.
Measured: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.
Parents will be asked the following questions about any treatment their child may have had for SDB
- Specialty of Dr seen and number of appointments
- Medical Treatment used, and duration he study team will describe additional treatment received by the treatment arm and investigate and describe any imbalance by the treatment arm. of treatment
Measured: 12 months
Number of adverse events (AEs) throughout the treatment phase
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Measured: 6 weeks
Number of adverse events (AEs) within the first week of the treatment
Participants will also be asked questions about hospitalisation, accidents, new or changed medications. In addition AE's will be documented from physical examination findings, clinically significant lab results or other documents (including diaries where solicited AE's are prompted and correspondence from their primary care physician) that are relevant to participant safety. Adverse events and adverse reactions (non-serious or serious will be captured) The number of AEs will be summarised and listed in each of the treatment arms.
Measured: 1 week
Compliance of medical therapy measured by weight of sent and returned bottles of medication
Bottles will be weighed before they are given to participants and weighed when they are returned. The amount used will be calculated and used to determine if the participant was compliant with dosing. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Compliance with treatment will be calculated as the proportion of prescribed doses over 6 weeks that was consumed based on the weight of the bottles. The mean compliance will be summarised for the run-in period and both treatment arms. The proportion of participants with 80% and more compliance will be given for each treatment arm. The amount of one spray of medication will be measured to allow for compliance to be calculated.
Measured: -6 weeks and 6 weeks (start of run-in phase to end of treatment phase)
Clinical factors at baseline that are associated with response to interventions, based on statistical analysis
Logistical regression models will be fitted to determine whether clinical factors at baseline or severity of SDB symptoms at baseline were associated with response to the intervention. Treatment arm, the symptom or factor of interest, and the interaction between the treatment arm and the symptom or factor will be included in this model. Symptoms or factors of interest include demographic factors, severity of SDB at baseline, history of atopy and history of tonsillitis.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start5 Dec 2022
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorder; Breathing-RelatedStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, double-blind, randomised control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Monash Health, Royal Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Kirsten Perrett, Principal investigator, Murdoch Children&#39;s Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382494
- Sponsor's protocol ID
- RCH HREC 81746
- Acronym
- MIST+
- Status last verified
- Sep 2025
- First submitted
- 16 May 2022
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set that will be collected for this analysis of the MIST+ trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered. Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institute, which has approved the proposed analysis plan.
Publications
Nixon GM, Anderson D, Baker A, Davidson A, Griffiths A, Grobler AC, Pinczower G, Rimmer J, Rose E, Selman CJ, Simpson CM, Vandeleur M, Perrett KP. Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial. JAMA Pediatr. 2026 Mar 1;180(3):240-249. doi: 10.1001/jamapediatrics.2025.5717.
PubMed 41557344
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05382494
- Acronym / sponsor ID
- MIST+ / RCH HREC 81746
- Conditions
- Sleep Disorder; Breathing-Related, Snoring, Obstructive Sleep Apnea of Child, Sleep Disorders in Children, Tonsillar Hypertrophy, Adenoidal Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Monash Health, Royal Children's Hospital
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.
Detailed description
MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre, double-blind, randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Intranasal Steroids | Experimental | Drug: Mometasone Furoate 50mcg Nasal Spray |
| Intranasal Saline | Placebo comparator | Drug: Sodium Chloride 0.9 % Nasal Spray |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Is between the ages of 3 and 12 years inclusive at the time of randomisation
- Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Key exclusion criteria (15 listed)
- Has a BMI over the 97th centile for age and gender
- Has a history of tonsillectomy and/or adenoidectomy
- Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
- Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
- Has a history of nasal surgery or trauma which has not fully healed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone Furoate 50mcg Nasal SprayAlso: Sensease Nasal Allergy Relief Nasal SprayIntranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks | Drug | Intranasal Steroids |
| Sodium Chloride 0.9 % Nasal SprayAlso: Intranasal Saline SprayIntranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks | Drug | Intranasal Saline |
Primary outcome
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks
Time frame: 6 weeks
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
35 secondary outcomes
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks
Time frame: 12 weeks
An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)
Time frame: 6 weeks
An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).
Time frame: 6 weeks
An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Time frame: 6 weeks
An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Time frame: 6 weeks
An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Time frame: 6 weeks
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks
Time frame: 6 weeks
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks
Time frame: 12 weeks
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months
Time frame: 6 months
Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks
Time frame: 6 weeks
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks
Time frame: 12 weeks
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months
Time frame: 6 months
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months
Time frame: 12 months
Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks
Time frame: 6 weeks
Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks
Time frame: 12 weeks
Proportion of parents who think their child still needs a review by a hospital specialist at 6 months
Time frame: 6 months
Proportion of parents who think their child still needs a review by a hospital specialist at 12 months
Time frame: 12 months
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks
Time frame: 6 weeks
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks
Time frame: 12 weeks
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months
Time frame: 6 months
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months
Time frame: 12 months
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)
Time frame: 6 weeks
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)
Time frame: 12 weeks
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months
Time frame: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months
Time frame: 12 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months
Time frame: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.
Time frame: 12 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months
Time frame: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months
Time frame: 12 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months
Time frame: 6 months
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.
Time frame: 12 months
Number of adverse events (AEs) throughout the treatment phase
Time frame: 6 weeks
Number of adverse events (AEs) within the first week of the treatment
Time frame: 1 week
Compliance of medical therapy measured by weight of sent and returned bottles of medication
Time frame: -6 weeks and 6 weeks (start of run-in phase to end of treatment phase)
Clinical factors at baseline that are associated with response to interventions, based on statistical analysis
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 41557344Nixon GM, Anderson D, Baker A, Davidson A, Griffiths A, Grobler AC, Pinczower G, Rimmer J, Rose E, Selman CJ, Simpson CM, Vandeleur M, Perrett KP. Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial. JAMA Pediatr. 2026 Mar 1;180(3):240-249. doi: 10.1001/jamapediatrics.2025.5717.
- Individual participant dataSharing planned: Yes. The de-identified data set that will be collected for this analysis of the MIST+ trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered. Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institute, which has approved the proposed analysis plan.
Related trials for Sleep Disorder; Breathing-Related
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Recruiting
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
Post Traumatic Stress Disorder, Obstructive Sleep Apnea
RecruitingObservational study
Is Change in Mouth Opening Related to Change in Quality of Life in Children With Type 1 Obstructive Sleep Apnea After Adenotonsillectomy?
Sleep Apnea, Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Perrett principal investigator
Murdoch Children&#39;s Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone Furoate 50mcg Nasal Spray and Sodium Chloride 0.9 % Nasal Spray in people with Sleep Disorder; Breathing-Related and Snoring, run by Murdoch Childrens Research Institute at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.