Obstructive Sleep ApneaPhase 3NCT05638087
Dexamethasone Treatment for OSA in Children
A Phase 3 study testing Dexamethasone in people with Obstructive Sleep Apnea, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 26 Oct 2022to 30 Dec 2025
- Phase
- Phase 3
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)
- Aged 2-10 years
- Presence of adenotonsillar hypertrophy
- Ability to take oral medication and be willing to adhere to the dosing regimen
- Informed consent provided in accordance with institutional policies
Who cannot join
- Previous adenotonsillectomy
- Presence of symptoms of an upper respiratory tract infection
- Co-existing central sleep apnea
- Hypertension
- Prior or current evidence for abnormal glucose tolerance
- Contraindication for dexamethasone or components of dexamethasone oral suspension,
Show all 11Show fewer
- Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention
- OSA with associated oxygen desaturations <90% for 2 continuous minutes
- Need for non-invasive ventilation long-term due to underlying disease
- Current systemic fungal infections
- Patients with clinically relevant varicella exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children
This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.
Read the detailed description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder affecting neonates to adolescents characterized by intermittent partial and complete upper airway obstruction leading to apneas.
The first line of treatment for OSA in young children is an adenotonsillectomy (AT). However, there are long surgical wait times for ATs, up to 3-6 months after a baseline polysomnogram(PSG). This leaves many children untreated, leading to a higher risk of learning deficits and long-term health effects.
Oral corticosteroids have long been used to treat airway inflammation and reduce inflammation of adenoid and tonsil tissue in-vitro. However, there is a lack of knowledge of oral steroids' efficacy in managing OSA. Additionally, the role of the nasal epithelium and the mechanism of action of dexamethasone role at a molecular level is unknown.
The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children in this proof-of-concept exploratory trial.
Participants will be screened by their baseline PSG, followed by 3 study visits conducted at SickKids. Participants will receive a 3-day course of oral dexamethasone or placebo at their first baseline study visit. During baseline, participants will undergo an otolaryngology assessment, a nasal brushing, and questionnaires. Participants will return 2 to 4 weeks after the intervention to the Hospital for Sick Children for a follow-up study visit which includes a repeat PSG, otolaryngology assessment and questionnaires. If no AT is performed within 6 months, participants will return for a third study visit for a repeat PSG, otolaryngology assessment and questionnaires.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Dexamethasone, Placebo Control
- Keywords
- Dexamethasone, Corticosteroid
- 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.
DexamethasoneDrug
Dexamethasone Oral Suspension
Placebo ControlDrug
Placebo Oral Mix
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Treatment | Experimental | Oral Dexamethasone treatment Receives: Drug: Dexamethasone |
| Placebo Treatment | Placebo comparator | Placebo control Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstructive apnea-hypopnea index
Change in obstructive apnea-hypopnea index from baseline.
The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to <5 events/hr; moderate OSA is defined as OAHI ≥5 to <10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr
Measured: Baseline and 2-4 weeks
Secondary outcomes (10)
Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score
Total CSHQ score of 41 has been reported to be a sensitive clinical cut-off point for detecting possible sleep problems
Measured: Baseline and 2-4 weeks
Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a validated parent-reported behavioural screening questionnaire and is used to assess children's mental health. The total difficulties score ranges from 0 to 40, a higher score indicates higher difficulties.
Measured: Baseline and 2-4 weeks
Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.
The OSA-18 QoL survey is a validated 18-item quality of life measure for children with sleep-disordered breathing (SDB) for children 2-18. Higher total scores indicate more impact on QoL - minor impact (scores below 60), moderate impact (scores between 60 and 80) and major impact (scores above 80).
Measured: Baseline and 2-4 weeks
Soft tissue size (Adenoids, Tonsils & Turbinates)
Change in soft tissue size (adenoids, tonsils and turbinates) from baseline
Measured: Baseline and 2-4 weeks
Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline
Inflammatory markers will be measured in basal media of cells cultured from nasal brushing by ELISA
Measured: At baseline
Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)
Cells from nasal brushing will be cultured and harvested for RNA to study gene expression.
Measured: At baseline
Participant recruitment rate
Feasibility determined by participant recruitment rate
Measured: From study start to completion; up to 6 months
Participant retention rate
Feasibility determined by participant retention rate
Measured: From study start to completion; up to 6 months
Participant adherence rate
Feasibility determined by participant adherence rate
Measured: From study start to completion; up to 6 months
Adverse events
Safety determined by number and severity of adverse events
Measured: From study start to completion; up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start26 Oct 2022
- Primary completion21 Jul 2024
- Study completion30 Dec 2025
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.
- More trials run by The Hospital for Sick ChildrenThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Narang, The Hospital for Sick Children
- Investigators
- Indra Narang, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638087
- Sponsor's protocol ID
- 1000079288
- Status last verified
- May 2026
- First submitted
- 2 Nov 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children
- ClinicalTrials.gov ID
- NCT05638087
- Acronym / sponsor ID
- 1000079288
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Dexamethasone, Corticosteroid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 6 Dec 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.
This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.
Detailed description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder affecting neonates to adolescents characterized by intermittent partial and complete upper airway obstruction leading to apneas.
The first line of treatment for OSA in young children is an adenotonsillectomy (AT). However, there are long surgical wait times for ATs, up to 3-6 months after a baseline polysomnogram(PSG). This leaves many children untreated, leading to a higher risk of learning deficits and long-term health effects.
Oral corticosteroids have long been used to treat airway inflammation and reduce inflammation of adenoid and tonsil tissue in-vitro. However, there is a lack of knowledge of oral steroids' efficacy in managing OSA. Additionally, the role of the nasal epithelium and the mechanism of action of dexamethasone role at a molecular level is unknown.
The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children in this proof-of-concept exploratory trial.
Participants will be screened by their baseline PSG, followed by 3 study visits conducted at SickKids. Participants will receive a 3-day course of oral dexamethasone or placebo at their first baseline study visit. During baseline, participants will undergo an otolaryngology assessment, a nasal brushing, and questionnaires. Participants will return 2 to 4 weeks after the intervention to the Hospital for Sick Children for a follow-up study visit which includes a repeat PSG, otolaryngology assessment and questionnaires. If no AT is performed within 6 months, participants will return for a third study visit for a repeat PSG, otolaryngology assessment and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Treatment | Experimental | Drug: DexamethasoneOral Dexamethasone treatment |
| Placebo Treatment | Placebo comparator | Drug: Placebo ControlPlacebo control |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)
- Aged 2-10 years
- Presence of adenotonsillar hypertrophy
- Ability to take oral medication and be willing to adhere to the dosing regimen
- Informed consent provided in accordance with institutional policies
Key exclusion criteria (11 listed)
- Previous adenotonsillectomy
- Presence of symptoms of an upper respiratory tract infection
- Co-existing central sleep apnea
- Hypertension
- Prior or current evidence for abnormal glucose tolerance
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 |
|---|---|---|
| DexamethasoneDexamethasone Oral Suspension | Drug | Dexamethasone Treatment |
| Placebo ControlPlacebo Oral Mix | Drug | Placebo Treatment |
Primary outcome
Obstructive apnea-hypopnea index
Time frame: Baseline and 2-4 weeks
Change in obstructive apnea-hypopnea index from baseline. The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to <5 events/hr; moderate OSA is defined as OAHI ≥5 to <10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr
10 secondary outcomes
Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score
Time frame: Baseline and 2-4 weeks
Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline and 2-4 weeks
Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.
Time frame: Baseline and 2-4 weeks
Soft tissue size (Adenoids, Tonsils & Turbinates)
Time frame: Baseline and 2-4 weeks
Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline
Time frame: At baseline
Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)
Time frame: At baseline
Participant recruitment rate
Time frame: From study start to completion; up to 6 months
Participant retention rate
Time frame: From study start to completion; up to 6 months
Participant adherence rate
Time frame: From study start to completion; up to 6 months
Adverse events
Time frame: From study start to completion; up to 6 months
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 12 May 2026.
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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.
Indra Narang, MD principal investigator
The Hospital for Sick Children
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 Dexamethasone in people with Obstructive Sleep Apnea, run by The Hospital for Sick Children 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 5 inclusion and 11 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 12 May 2026. 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. 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?
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?
Obstructive apnea-hypopnea index (time frame: Baseline and 2-4 weeks). 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 12 May 2026.