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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Indra Narang, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+