Dexamethasone Treatment for OSA in Children

NCT05638087 | Completed Phase 3 DMC

• 1 other identifier: 1000079288
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 treatment to manage the severity and symptoms in children with moderate to severe OSA.

Conditions

Obstructive Sleep Apnea

Keywords

Dexamethasone; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 2-4 weeks

Secondary Outcomes (10)

• Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score

  Baseline and 2-4 weeks

• Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)

  Baseline and 2-4 weeks

• Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.

  Baseline and 2-4 weeks

• Soft tissue size (Adenoids, Tonsils & Turbinates)

  Baseline and 2-4 weeks

• Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline

  At baseline

Study Arms (2)

Dexamethasone Treatment

EXPERIMENTAL

Oral Dexamethasone treatment

Drug: Dexamethasone

Placebo Treatment

PLACEBO COMPARATOR

Placebo control

Drug: Placebo Control

Interventions

Dexamethasone DRUG

Dexamethasone Oral Suspension

Dexamethasone Treatment

Placebo Control DRUG

Placebo Oral Mix

Placebo Treatment

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V 1X8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Indra Narang, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scientist

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: December 6, 2022
• Study Start: October 26, 2022
• Primary Completion: July 21, 2024
• Study Completion: December 30, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CA (1)