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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Obstructive apnea-hypopnea index
Secondary study objectives
Arousal index
Comfort score
Oxygen
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
710 Previous Clinical Trials
6,958,172 Total Patients Enrolled
Indra Narang, MDPrincipal InvestigatorThe Hospital for Sick Children
3 Previous Clinical Trials
384 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You sleep less than 4 hours during a special test called a polysomnogram.You can't handle the electrodes used for a sleep test.You use the continuous positive airway pressure machine for at least 6 hours every night.You have a sleep test that shows you have 5-30 episodes of breathing pauses per hour while sleeping.You have a specific type of sleep apnea that is worse when you sleep on your back, as shown by a sleep test.Kids between 4 and 18 years old.You have a current infection in your nose, throat, or sinuses.You live more than 200 kilometers away from the study site.You can't move around by yourself.You need to use oxygen therapy.The child needs special breathing support, as determined by their doctor, due to conditions like central sleep apnea or chronic respiratory failure.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Positional Sleep Belt
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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