Obstructive Sleep Apnea SyndromePhase 3SPARKNCT02180672
Steroids for Pediatric Apnea Research in Kids
A Phase 3 study testing Nasal Fluticasone in people with Obstructive Sleep Apnea Syndrome, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Nasal Fluticasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 30 Oct 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5-10 years of age.
- Mild to moderate OSAS, defined as an obstructive apnea index of 1-20/hr of total sleep time or obstructive apnea hypopnea index of 2-30/hr of total sleep time.
- Parent-related symptoms of habitual snoring (>3 nights per week)
- No history of adenotonsillectomy.
- Parental/guardian permission (informed consent) and if appropriate, child assent
Who cannot join
- Severe OSAS or significant hypoxemia or hypercapnia on polysomnography, such that definitive treatment should not be delayed (AHI > 30/hr, more than 2% total sleep time with arterial oxygen saturation (SpO2) <90%, end-tidal carbon dioxide partial pressure (PCO2) > 60 mm Hg for > 5 minutes, pathologic arrhythmias).
- History of recurrent throat infections (as defined by the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines For Tonsillectomy (7)) in the past few years as follows: > 7 episodes in the past year or > 5 episodes/year over the past 2 years or > 3 episodes/year over the past 3 years.
- Abnormalities on baseline safety screening tests, i.e., Dual Energy X-ray Absorptiometry (DXA) scan showing spine or whole body bone mineral density < -2.0 standard deviations using race specific curves with adjustment for height Z-score; morning cortisol < 3 µg/dl or morning adrenocorticotropic hormone (ACTH) < 10 pg/ml; or ophthalmologic exam demonstrating cataracts (except those with < 2 mm anterior polar cataracts), aphakia or other ocular abnormalities such as glaucoma, retinal coloboma, intraocular inflammation or microphthalmia.
- Failure to thrive (weight/height < 5th percentile for age and gender), as this may be secondary to OSAS.
- Severe obesity (BMI z-score > 3) as OSAS is likely to persist in these subjects.
- Previous adenoidectomy unless adenoidal tissue has been documented to have regrown.
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- Previous tonsillectomy.
- Continuous positive airway pressure (CPAP) therapy.
- Any NCS use in the past 3 months or NCS use for > 2 weeks in the past year.
- Current immunotherapy or daily antihistamine use.
- Recent (past month) nasal septum ulcers, surgery or trauma.
- Other major illness other than asthma, such as craniofacial anomalies, endocrine or neuromuscular disease, or past history of cancer. This includes children with conditions that may be worsened by OSAS, such as hypertension or diabetes.
- Current use of ketoconazole or other potent CYP3A4 inhibitors.
- Families planning to move out of the area within the year.
- Subjects who do not speak either English or Spanish well enough to complete the validated neurobehavioral instruments.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.
Read the detailed description
Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists may be effective in the treatment of childhood OSAS. However, these studies have been limited by factors such as small size, lack of randomization and blinding, short-term follow-up, involvement of children with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate childhood OSAS, particularly in children with asthma/atopy, but will require ongoing maintenance therapy.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Nasal Fluticasone, Placebo
- Keywords
- Obstructive sleep apnea syndrome, OSA, sleep apnea, nasal steroids, corticosteroids
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal FluticasoneDrug
Also called NCS, Nasal steroids, Nasal corticosteroids
One spray per nostril, per day.
PlaceboDrug
Also called Saline
One spray per nostril, per day.
| Study group | Role | What they receive |
|---|---|---|
| Nasal steroids | Active comparator | Participants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone). Receives: Drug: Nasal Fluticasone |
| Placebo | Placebo comparator | Participants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive Apnea Hypopnea Index
Efficacy measure to assess acute response to nasal steroids.
Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points.
The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.
Measured: 3 months
Secondary outcomes (9)
OAHI
Efficacy measure to assess duration of response to nasal steroids.
Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points.
Measured: 12 months
Nasal Obstruction Symptom Evaluation (NOSE)
Nasal Obstruction Symptom Evaluation (NOSE) scale, a validated scale of nasal obstructive symptoms. The scales ranges from 0-100 with higher values indicating worse nasal obstruction
Measured: 12 months
The Epworth Sleepiness Scale
Epworth Sleepiness scale is a measure of sleepiness that ranges from 0-24, with higher values indicating sleepiness
Measured: 12 months
Pediatric Quality of Life Inventory (PedsQL)
Pediatric Quality of Life Inventory (PedsQL), a well-validated, generic measure of global quality of life, in which scores range from 0 to 100, with higher scores indicating better quality of life
Measured: 12 month
Behavior Rating Inventory of Executive Function (BRIEF)
Behavior Rating Inventory of Executive Function [BRIEF] Global Executive Composite T score, comprising summary measures of behavioral regulation and metacognition [with mean scores of 50 and standard deviation of 10, with higher scores indicating worse functioning]
Measured: 12 months
Conners Abbreviated Symptom Questionnaire
A parent-rated measure of symptoms of attention problems, yielding T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning).
Measured: 12 months
Purdue Peg Board
The Purdue Peg Board is a widely used test of fine motor coordination, yields z-scores with a mean of 0 and a standard deviation of 1, with higher scores indicating better performance.
Measured: 12 months
Conners Continuous Performance Test (CPT)
The CPT is a performance measure of sustained attention that yields T scores with a mean of 50 and a standard deviation of 10 (higher scores indicate worse functioning)
Measured: 12 months
Child Behavior Checklist
The Child Behavior Checklist (CBCL), is a widely used and validated caregiver-completed survey of behavior competencies that yields standardized, age-adjusted scores on internalizing, externalizing and attentional behavior difficulties81, 82. All scores are T scores with a mean of 50 and standard deviation of 10 (higher scores indicate worse functioning).
Measured: 12-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startSep 2014
- Primary completion30 Dec 2019
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Carole L Marcus, MBBCh, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180672
- Sponsor's protocol ID
- 14-010942
- Other IDs
- R01HL120909
- Acronym
- SPARK
- Status last verified
- Nov 2021
- First submitted
- 1 Jul 2014
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chidambaram AG, Cielo CM, Chervoneva I, Spergel JM, Tapia IE. Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome. J Clin Sleep Med. 2025 Jun 1;21(6):1033-1040. doi: 10.5664/jcsm.11604.
PubMed 40051199Tapia IE, Shults J, Cielo CM, Kelly AB, Elden LM, Spergel JM, Bradford RM, Cornaglia MA, Sterni LM, Radcliffe J. A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome. Chest. 2022 Oct;162(4):899-919. doi: 10.1016/j.chest.2022.06.026. Epub 2022 Jun 30.
PubMed 35779610
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02180672
- Acronym / sponsor ID
- SPARK / 14-010942
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive sleep apnea syndrome, OSA, sleep apnea, nasal steroids, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2014
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Posted 10 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.
Detailed description
Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists may be effective in the treatment of childhood OSAS. However, these studies have been limited by factors such as small size, lack of randomization and blinding, short-term follow-up, involvement of children with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate childhood OSAS, particularly in children with asthma/atopy, but will require ongoing maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal steroids | Active comparator | Drug: Nasal FluticasoneParticipants randomly assigned to this study arm will receive a 3-month course of nasal steroids (nasal fluticasone). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomly assigned to this study arm will receive a 3-month course of placebo nasal spray (saline). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 5-10 years of age.
- Mild to moderate OSAS, defined as an obstructive apnea index of 1-20/hr of total sleep time or obstructive apnea hypopnea index of 2-30/hr of total sleep time.
- Parent-related symptoms of habitual snoring (>3 nights per week)
- No history of adenotonsillectomy.
- Parental/guardian permission (informed consent) and if appropriate, child assent
Key exclusion criteria (16 listed)
- Severe OSAS or significant hypoxemia or hypercapnia on polysomnography, such that definitive treatment should not be delayed (AHI > 30/hr, more than 2% total sleep time with arterial oxygen saturation (SpO2) <90%, end-tidal carbon dioxide partial pressure (PCO2) > 60 mm Hg for > 5 minutes, pathologic arrhythmias).
- History of recurrent throat infections (as defined by the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines For Tonsillectomy (7)) in the past few years as follows: > 7 episodes in the past year or > 5 episodes/year over the past 2 years or > 3 episodes/year over the past 3 years.
- Abnormalities on baseline safety screening tests, i.e., Dual Energy X-ray Absorptiometry (DXA) scan showing spine or whole body bone mineral density < -2.0 standard deviations using race specific curves with adjustment for height Z-score; morning cortisol < 3 µg/dl or morning adrenocorticotropic hormone (ACTH) < 10 pg/ml; or ophthalmologic exam demonstrating cataracts (except those with < 2 mm anterior polar cataracts), aphakia or other ocular abnormalities such as glaucoma, retinal coloboma, intraocular inflammation or microphthalmia.
- Failure to thrive (weight/height < 5th percentile for age and gender), as this may be secondary to OSAS.
- Severe obesity (BMI z-score > 3) as OSAS is likely to persist in these subjects.
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 |
|---|---|---|
| Nasal FluticasoneAlso: NCS, Nasal steroids, Nasal corticosteroidsOne spray per nostril, per day. | Drug | Nasal steroids |
| PlaceboAlso: SalineOne spray per nostril, per day. | Drug | Placebo |
Primary outcome
Obstructive Apnea Hypopnea Index
Time frame: 3 months
Efficacy measure to assess acute response to nasal steroids. Obstructive apnea hypopnea index (events per hour). Per inclusion/exclusion criteria the expected range for this study at baseline is between 2 and 30 events per hour. Please note that lower and upper ranges can be broader at the 3- and 12-month points. The obstructive apnea hypopnea index (OAHI) is the sum of obstructive apneas and hypopneas, and mixed apneas divided by the total hours of sleep. Hence, the unit used is events per hour. It ranges from 0 events per hour(meaning no obstructive apneas at all) until 400 events per hour approximately. Higher values indicate more severe obstructive sleep apnea or worse outcome.
9 secondary outcomes
OAHI
Time frame: 12 months
Nasal Obstruction Symptom Evaluation (NOSE)
Time frame: 12 months
The Epworth Sleepiness Scale
Time frame: 12 months
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 12 month
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: 12 months
Conners Abbreviated Symptom Questionnaire
Time frame: 12 months
Purdue Peg Board
Time frame: 12 months
Conners Continuous Performance Test (CPT)
Time frame: 12 months
Child Behavior Checklist
Time frame: 12-Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40051199Chidambaram AG, Cielo CM, Chervoneva I, Spergel JM, Tapia IE. Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome. J Clin Sleep Med. 2025 Jun 1;21(6):1033-1040. doi: 10.5664/jcsm.11604.
- Derived from this study: PubMed 35779610Tapia IE, Shults J, Cielo CM, Kelly AB, Elden LM, Spergel JM, Bradford RM, Cornaglia MA, Sterni LM, Radcliffe J. A Trial of Intranasal Corticosteroids to Treat Childhood OSA Syndrome. Chest. 2022 Oct;162(4):899-919. doi: 10.1016/j.chest.2022.06.026. Epub 2022 Jun 30.
- Related InfoLink provided by the sponsor.
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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.
Carole L Marcus, MBBCh principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nasal Fluticasone in people with Obstructive Sleep Apnea Syndrome, run by Children's Hospital of Philadelphia at 1 site in United States.
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 5 inclusion and 16 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 10 Nov 2021. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Obstructive Apnea Hypopnea Index (time frame: 3 months). 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 NCT02180672, which also lists 2 linked publications.
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 10 Nov 2021.