Dexamethasone for Obstructive Sleep Apnea in Children

Overseen By Mystica Terrance, BSc

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: The Hospital for Sick Children

Must not be taking: Corticosteroids

Disqualifiers: Hypertension, Abnormal glucose tolerance, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a short course of dexamethasone, an oral steroid, can help manage symptoms in children with moderate to severe obstructive sleep apnea (OSA), a condition where breathing repeatedly stops during sleep. Researchers will randomly assign participants to receive either the steroid or a placebo (a harmless pill with no active medicine) to determine if the steroid improves their sleep condition. Children diagnosed with moderate to severe OSA and who have enlarged tonsils and adenoids might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used nasal or systemic corticosteroids in the last 4 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexamethasone is usually well-tolerated in children. This steroid, already used to treat other conditions, helps reduce inflammation, suggesting it is likely safe for short-term use.

Although specific studies on dexamethasone's side effects in children with obstructive sleep apnea (OSA) are not mentioned here, its use in other pediatric treatments has demonstrated safety when used correctly. As a Phase 3 trial, earlier studies have likely shown it to be safe enough for larger groups. This indicates it is not expected to cause serious side effects for most children. However, like any medication, some children might experience mild side effects such as an upset stomach or mood changes.

For more specific concerns or questions, it is advisable to consult the trial team or your child's doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obstructive sleep apnea?

Most treatments for obstructive sleep apnea in children involve surgical procedures like tonsillectomy or adenoidectomy, or the use of continuous positive airway pressure (CPAP) devices. Unlike these options, dexamethasone is a corticosteroid that works by reducing inflammation and swelling in the airways. This oral medication could offer a less invasive alternative, potentially improving sleep apnea symptoms without surgery. Researchers are excited about dexamethasone because it targets the underlying inflammation, possibly providing relief with fewer side effects and greater convenience compared to current treatments.

What evidence suggests that dexamethasone might be an effective treatment for obstructive sleep apnea in children?

Research has shown that dexamethasone, an oral steroid, might help treat obstructive sleep apnea (OSA) in children. One study found that combining dexamethasone with nasal tramazoline reduced apnea episodes by 21%. This suggests that dexamethasone could lessen the severity of OSA symptoms in children. Another study examined oral steroids like dexamethasone and found them promising for managing OSA in children. These findings offer hope for using dexamethasone to treat OSA in this population. In this trial, participants will receive either dexamethasone or a placebo to evaluate its effectiveness in treating OSA. ^{1 2 4 6 7}

Who Is on the Research Team?

Indra Narang, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for children aged 2-10 with moderate to severe obstructive sleep apnea, who can take oral medication and have adenotonsillar hypertrophy. It's not for kids who've had an adenotonsillectomy, need long-term ventilation, have central sleep apnea or a current infection, hypertension, abnormal glucose tolerance, recent steroid treatment, oxygen issues during sleep or exposure to varicella.

Inclusion Criteria

I am between 2 and 10 years old.

Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)

I can take pills and will follow the medication schedule.

Exclusion Criteria

Prior or current evidence for abnormal glucose tolerance

Contraindication for dexamethasone or components of dexamethasone oral suspension

Patients with clinically relevant varicella exposure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a 3-day course of oral dexamethasone or placebo

3 days

1 visit (in-person)

Follow-up

Participants return for follow-up visits to assess treatment efficacy and safety

2-4 weeks

2 visits (in-person)

Extended Follow-up

Participants return for a third study visit if no adenotonsillectomy is performed within 6 months

Up to 6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Placebo Control

Trial Overview The study tests if a short course of dexamethasone improves obstructive sleep apnea in children compared to a placebo. Participants are randomly given either the steroid or placebo without knowing which one they receive (double-blinded), and their sleep is monitored twice using polysomnograms.

How Is the Trial Designed?

Group I: Dexamethasone Treatment Experimental Treatment 1 Intervention

Oral Dexamethasone treatment

Group II: Placebo Treatment Placebo Group 1 Intervention

Placebo control

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474685/

Predicting treatment success in pediatric mild-to-moderate OSA This study presents a validated nomogram model based on PSG and clinical parameters to predict treatment response to INCS in pediatric OSA, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06917768

Oral Corticosteroids' Role in Pediatric Obstructive Sleep ... Evaluate the effectiveness of low-dose, short-term oral corticosteroids in the treatment of OSA in children. In Group 2, failure of medical treatment is defined ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945724000303

Pharmacological interventions for pediatric obstructive ... The combination of mometasone furoate nasal spray and oral montelukast sodium exhibits the highest probability of being the most effective intervention.

4. trialx.com trialx.com/clinical-trials/listings/236202/dexamethasone-treatment-for-osa-in-children/?&radius=50

Dexamethasone Treatment for OSA in Children This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram ...

5. withpower.com withpower.com/trial/phase-2-sleep-apnea-obstructive-1-2025-06e9f

Dexamethasone for Obstructive Sleep Apnea A study showed that using a combination of nasal tramazoline and dexamethasone in patients with obstructive sleep apnea led to a 21% decrease in the apnoea/ ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02180672

Steroids for Pediatric Apnea Research in Kids ... 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, ...

7. withpower.com withpower.com/trial/phase-3-sleep-apnea-obstructive-9-2022-11cdc

Dexamethasone 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).