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Corticosteroid

Dexamethasone for Obstructive Sleep Apnea in Children

Phase 3
Recruiting
Led By Indra Narang, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study start to completion; up to 6 months
Awards & highlights

Study Summary

This trial will test if an oral steroid, dexamethasone, can help manage the symptoms of moderate to severe OSA in children.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Dexamethasone may cause side effects like increased appetite, mood changes, stomach upset, high blood sugar levels especially in diabetic patients; it might also weaken the immune system making it easier to get infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study start to completion; up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study start to completion; up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Obstructive apnea-hypopnea index
Secondary outcome measures
Adverse events
Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score
Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.
+7 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dexamethasone TreatmentExperimental Treatment1 Intervention
Oral Dexamethasone treatment
Group II: Placebo TreatmentPlacebo Group1 Intervention
Placebo control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
689 Previous Clinical Trials
6,945,399 Total Patients Enrolled
Indra Narang, MDPrincipal InvestigatorThe Hospital for Sick Children
3 Previous Clinical Trials
386 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05638087 — Phase 3
Obstructive Sleep Apnea Research Study Groups: Dexamethasone Treatment, Placebo Treatment
Obstructive Sleep Apnea Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05638087 — Phase 3
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638087 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for this research endeavor?

"Affirmative. Clinicaltrials.gov depicts that this medical study is presently looking for volunteers, having been initially posted on October 26th 2022 and recently updated on December first 2022. They are currently in search of 22 participants at a single site."

Answered by AI

How many individuals are currently enrolled in this experiment?

"Affirmative. Clinicaltrials.gov data confirms that this research trial is currently recruitment participants, which began on October 26th 2022. As of December 1st 2022, the study is accepting applications from 22 patients to be admitted at one medical centre."

Answered by AI

Are individuals who are over 25 years old eligible to join this experiment?

"This clinical trial includes a narrow age-range of participants, exclusively requiring those between 2 and 10 years old. By comparison, there are 43 studies catered to people under 18 while 232 trials cater to seniors over 65."

Answered by AI

Are there any prerequisites for participating in this clinical experiment?

"For this clinical trial, 22 children aged 2-10 with a diagnosis of moderate to severe obstructive sleep apnea (OSA), adenotonsillar hypertrophy and the ability to swallow oral medication are being sought. Moreover, patient assent must be provided in line with local guidelines."

Answered by AI

Is Dexamethasone Treatment relatively risk-free for people?

"The safety of the Dexamethasone Treatment was assessed at 3, due to the presence of various clinical data points validating its efficacy and multiple reports confirming its security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dexamethasone Treatment for OSA in Children
Indra Narang 2022. "Dexamethasone Treatment for OSA in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05638087.
~2 spots leftby Jun 2024
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