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Positional Sleep Belt for Pediatric Obstructive Sleep Apnea

N/A
Waitlist Available
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
Children aged 4 to 18 years old
Diagnosed with positional obstructive sleep apnea on baseline diagnostic polysomnogram as defined as: supine-to-nonsupine obstructive apnea-hypopnea index ratio of 2 or greater, 10-90% total sleep time in supine position
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will compare a positional sleep therapy belt to a control in children diagnosed with positional obstructive sleep apnea.

Who is the study for?
The SleepPOSAtive Trial is for children aged 4 to 18 with mild to moderate positional obstructive sleep apnea, confirmed by a specific test called polysomnogram. They must spend a significant portion of their sleep on their back and be able to move independently. Kids using CPAP therapy regularly or those with certain health conditions are not eligible.Check my eligibility
What is being tested?
This study tests the effectiveness of a positional sleep therapy belt in treating obstructive sleep apnea in kids compared to a control group without the belt. Over four weeks, participants will have two overnight studies (polysomnograms) in random order to see if there's any improvement.See study design
What are the potential side effects?
Since this trial involves using a non-invasive sleep belt, side effects are expected to be minimal but may include discomfort from wearing the device during sleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Kids between 4 and 18 years old.
Select...
You have a specific type of sleep apnea that is worse when you sleep on your back, as shown by a sleep test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Arousal index
Comfort score
Oxygen
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Positional Sleep BeltExperimental Treatment1 Intervention
Rematee Positional Sleep Belt
Group II: ControlActive Control1 Intervention
Active Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positional Sleep Belt
2022
N/A
~30

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
682 Previous Clinical Trials
6,945,310 Total Patients Enrolled
Indra Narang, MDPrincipal InvestigatorThe Hospital for Sick Children
3 Previous Clinical Trials
384 Total Patients Enrolled

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT05499455 — N/A
Obstructive Sleep Apnea Research Study Groups: Control, Positional Sleep Belt
Obstructive Sleep Apnea Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT05499455 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT05499455 — N/A

Frequently Asked Questions

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

Does the age limit for this experiment exceed 25 years?

"The requirements for participation in this study necessitate that all participants are aged between 4 to 18 years old. Additionally, 41 clinical trials exist for minors and 230 studies focus on the elderly population."

Answered by AI

Is this research looking for new participants at the moment?

"Indeed, clinicaltrials.gov shows that this trial is open for enrollment and is currently recruiting 40 participants from a single site. The initial posting was made on February 13th 2022 with the most recent update happening on August 10th of the same year."

Answered by AI

What is the current participant count for this clinical trial?

"Affirmative. Clinicaltrials.gov suggests that this medical trial is in the process of recruiting participants, with first postings on 13th February 2022 and most recent updates from 10th August 2022. This study requires 40 patients to be sourced from one medical facility."

Answered by AI

Are there any restrictions for participants wishing to take part in this clinical trial?

"For this trial, 40 minors aged 4 to 18 with obstructive sleep apnea (OSA) and an OAHI score of 5-30 events/hour on the baseline polysomnogram will be accepted. All children must meet the definition of positional OSA as well as provide consent from a caregiver, or assent if possible."

Answered by AI
~8 spots leftby Mar 2025