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Positional Sleep Belt for Pediatric Obstructive Sleep Apnea
Study Summary
This trial will compare a positional sleep therapy belt to a control in children diagnosed with positional obstructive sleep apnea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Control
- Group 2: Positional Sleep Belt
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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