Obstructive Sleep ApneaPERSIST-BNCT03061019
Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea
A study testing Oral Myofunctional Therapy with exercices and Oral Myofunctional Therapy with soft oral appliance in people with Obstructive Sleep Apnea, run by Université de Montréal at 1 site in Canada.
Trial summary
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oral Myofunctional Therapy with exercices and Oral Myofunctional Therapy with soft oral appliance
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 31 Jan 2024
- Phase
- Interventional
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the hierarchical questionnaire of severity of Spruyt and Gozal, greater than or equal to 2,72- This questionnaire comprises six Questions and has a good sensitivity (60%) and specificity (82%) in screening for pediatric sleep apnea.
- be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more).
Who cannot join
- present with a craniofacial syndrome nor a severe medical condition with complex medical management,
- present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)
- receive orthodontic therapy during the study
- have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion.
- A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation, and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea Before Adenotonsillectomy : a Randomized Controlled Trial.
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible oral appliance, both in combination with nasal hygiene), compared to nasal hygiene alone (control group).
Read the detailed description
Introduction: Paediatric Obstructive Sleep Apnea (OSA) is a multifactorial condition, associated with significant comorbidities, affecting cardiovascular health, cognitive development and quality of life. Its main cause is adenotonsillar hypertrophy, but some co-factors such as obesity, orofacial dysfunctions and craniofacial abnormalities contribute to the severity of symptoms or their persistance after adeno-tonsillectomy.
Aim : Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes (AHI) of children, and can serve as an adjunct to other therapies, but the level of compliance is a limiting factor. The investigator's aim is to evaluate two methods of oral reeducation in a group a children scheduled for adeno-tonsillectomy (in association with nasal hygiene) and to compare them with nasal hygiene alone (control group).
Methods : The design of the study is a randomized Controlled Trial, enrolling 60 children with significant obstructive sleep apnea and divided into 3 groups : Group 1 following daily oral exercises (+nasal hygiene), Group 2 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 3 using nasal hygiene alone (control group). The objective assessment of sleep parameters is performed at home using an ambulatory device (AHI, desaturation index, minimal oxygen saturation, flow limitation, snoring), before and after therapy, in a 3 months interval. An orthodontic and craniofacial assessment, the examination of orofacial functions and tongue/lip strength measurements (IOPI system), as well as quality of life questionnaires (OSA-18) are also performed on participants, before and after therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oral Myofunctional Therapy with exercices, Oral Myofunctional Therapy with soft oral appliance
- Keywords
- child, myofunctional therapy, adenotonsillectomy, randomized controlled trial
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Myofunctional Therapy with exercicesProcedure or surgery
Also called Oral reeducation
Oral-Motor training of oral muscles (tongue, lips) associated with nasal hygiene with daily repetition of exercices and parental support.
Oral Myofunctional Therapy with soft oral applianceProcedure or surgery
Also called Oral Trainer
Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
| Study group | Role | What they receive |
|---|---|---|
| Myofunctional Oral Exercices | Active comparator | Parents and participants of this group will receive instructions for nasal and oral myo-functional exercises, to perform at home each day, for 5 to 10 minutes. A booklet (measure of adherence) and an Phone application for Android/Apple with descriptions/videos of those exercices will be given to them. These exercises will include nasal hygiene procedures, nasal cartilage exercices, lingual posture rehabilitation exercises, lip tone enhancement exercises, and swallowing rehabilitation exercises. Receives: Procedure: Oral Myofunctional Therapy with exercices |
| Soft Oral Appliance | Experimental | Parents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth. Receives: Procedure: Oral Myofunctional Therapy with soft oral appliance |
| Control Group | No intervention | Parents and Participants of this group will be reminded the nasal hygiene procedures (application of saline in each nostril three times a day), and given a diary to report daily use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of apnea and hypopnea/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children.
Measured: Baseline and 3 months
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of oxygen desaturation per hour/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (oximetry).
Measured: Baseline and 3 months
Sleep Parameters Changes : Flow Limitation index
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of flow limitations per hour , in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (nasal canula or thermistance).
Measured: Baseline and 3 months
Secondary outcomes (3)
Oral muscles strength
Lip and Tongue strength and endurance measurement with the IOPI measurement system: Measurement of Anterior and Posterior tongue elevation strength (kPa), Lip Seal strength (kPa)
Measured: Baseline and 3 months
Nasal Resistance
Nasal resistance measurements with a anterior rhino-manometry : effective resistance left nostril (expiration, inspiration), effective resistance right nostril Pa/cm3/s during expiration, inspiration) ,total breath resistance (Pa/cm3/s during expiration, inspiration), vertex resistance right, vertex resistance left (Pa/cm3/s during inspiration, expiration).
Measured: Baseline and 3 months
Quality of Life
OSA 18 Questionnaire, consisting of a 18-items score and Visual Analog scale (from 0 to 10), filled by parents.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completion7 Aug 2023
- Study completion31 Jan 2024
Why it stopped: a RCT was started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- St. Justine's Hospital
- Responsible party
- Principal investigator, Nelly Huynh, Université de Montréal
- Investigators
- Nelly Huynh, PhD, Principal investigator, Université de Montréal, Montréal, Québec, CanadaMarie-Claude Quintal, MD, Principal investigator, Hôpital Sainte-Justine, Montréal, QC, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061019
- Sponsor's protocol ID
- 2017-1297
- Acronym
- PERSIST-B
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2017
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Oral Myofunctional Reeducation Methods for Children With Obstructive Sleep Apnea Before Adenotonsillectomy : a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03061019
- Acronym / sponsor ID
- PERSIST-B / 2017-1297
- Conditions
- Obstructive Sleep Apnea
- Keywords
- child, myofunctional therapy, adenotonsillectomy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: a RCT was started
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- St. Justine's Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 23 Feb 2017 (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.
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric sleep apnea. As the effectiveness of reeducation relies on parental involvement and child's compliance, the investigator's research question was to evaluate two methods of myofunctional therapy (daily oral exercices versus a flexible oral appliance, both in combination with nasal hygiene), compared to nasal hygiene alone (control group).
Detailed description
Introduction: Paediatric Obstructive Sleep Apnea (OSA) is a multifactorial condition, associated with significant comorbidities, affecting cardiovascular health, cognitive development and quality of life. Its main cause is adenotonsillar hypertrophy, but some co-factors such as obesity, orofacial dysfunctions and craniofacial abnormalities contribute to the severity of symptoms or their persistance after adeno-tonsillectomy.
Aim : Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes (AHI) of children, and can serve as an adjunct to other therapies, but the level of compliance is a limiting factor. The investigator's aim is to evaluate two methods of oral reeducation in a group a children scheduled for adeno-tonsillectomy (in association with nasal hygiene) and to compare them with nasal hygiene alone (control group).
Methods : The design of the study is a randomized Controlled Trial, enrolling 60 children with significant obstructive sleep apnea and divided into 3 groups : Group 1 following daily oral exercises (+nasal hygiene), Group 2 using of a flexible oral appliance during quiet activities and sleep (+nasal hygiene), and Group 3 using nasal hygiene alone (control group). The objective assessment of sleep parameters is performed at home using an ambulatory device (AHI, desaturation index, minimal oxygen saturation, flow limitation, snoring), before and after therapy, in a 3 months interval. An orthodontic and craniofacial assessment, the examination of orofacial functions and tongue/lip strength measurements (IOPI system), as well as quality of life questionnaires (OSA-18) are also performed on participants, before and after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Myofunctional Oral Exercices | Active comparator | Procedure: Oral Myofunctional Therapy with exercicesParents and participants of this group will receive instructions for nasal and oral myo-functional exercises, to perform at home each day, for 5 to 10 minutes. A booklet (measure of adherence) and an Phone application for Android/Apple with descriptions/videos of those exercices will be given to them. These exercises will include nasal hygiene procedures, nasal cartilage exercices, lingual posture rehabilitation exercises, lip tone enhancement exercises, and swallowing rehabilitation exercises. |
| Soft Oral Appliance | Experimental | Procedure: Oral Myofunctional Therapy with soft oral applianceParents and participants will be instructed in wearing the soft/flexible oral appliance and how to perform nasal hygiene in order to better tolerate the device. The oral appliance comes in several sizes, adapted to the age of the child; it is constructed in a soft elastomer material, in a position of slight propulsion and opening of the mandible to help clear the pharynx. It has a ramp to guide the tongue in a good position, a labial screen to stretch the labial strap and prevent the tongue from protruding between front teeth. |
| Control Group | No intervention | –Parents and Participants of this group will be reminded the nasal hygiene procedures (application of saline in each nostril three times a day), and given a diary to report daily use. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- present signs of obstructive sleep apnea: snoring, apnea / respiratory pauses audible by the entourage (objectivized by a score, to the hierarchical questionnaire of severity of Spruyt and Gozal, greater than or equal to 2,72- This questionnaire comprises six Questions and has a good sensitivity (60%) and specificity (82%) in screening for pediatric sleep apnea.
- be programmed for adenoidectomy, tonsillectomy or adeno-tonsillectomy within 3 months (or more).
Key exclusion criteria (5 listed)
- present with a craniofacial syndrome nor a severe medical condition with complex medical management,
- present with an abnormality of the neuromuscular tone (such as Duchenne myopathy or cerebral palsy)
- receive orthodontic therapy during the study
- have a class III malocclusion (mandibular prognathy type), for which a propulsion oral appliance is contraindicated because it may aggravate mandibular prominence. Maxillary deficiency is not a exclusion criterion.
- A non-nutritive oral habit such as digital sucking (or pacifier) that persists because it interferes with oral reeducation, and is a contraindication to orthodontic treatments. Children who have recently stopped such a habit may be included in the study.
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 |
|---|---|---|
| Oral Myofunctional Therapy with exercicesAlso: Oral reeducationOral-Motor training of oral muscles (tongue, lips) associated with nasal hygiene with daily repetition of exercices and parental support. | Procedure or surgery | Myofunctional Oral Exercices |
| Oral Myofunctional Therapy with soft oral applianceAlso: Oral TrainerOra-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support. | Procedure or surgery | Soft Oral Appliance |
Primary outcome
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Time frame: Baseline and 3 months
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of apnea and hypopnea/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children.
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Time frame: Baseline and 3 months
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of the index of oxygen desaturation per hour/ in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (oximetry).
Sleep Parameters Changes : Flow Limitation index
Time frame: Baseline and 3 months
Full Night Polygraph using an ambulatory device Type III (cardio-respiratory); measurement of flow limitations per hour , in relation to total sleep time, according the American Association of Sleep Medicine (AASM) recommandations for children (nasal canula or thermistance).
3 secondary outcomes
Oral muscles strength
Time frame: Baseline and 3 months
Nasal Resistance
Time frame: Baseline and 3 months
Quality of Life
Time frame: Baseline and 3 months
Results and safety
The study was stopped early (reason given: a RCT was started). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Nelly Huynh, PhD principal investigator
Université de Montréal, Montréal, Québec, Canada
Marie-Claude Quintal, MD principal investigator
Hôpital Sainte-Justine, Montréal, QC, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Myofunctional Therapy with exercices and Oral Myofunctional Therapy with soft oral appliance in people with Obstructive Sleep Apnea, run by Université de Montréal at 1 site in Canada.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: a RCT was started). Results are not available in the source record.
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?
Sleep Parameters Changes : Apnea Hypopnea Index (AHI) (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.