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Obese for Obstructive Sleep Apnea
N/A
Waitlist Available
Led By Indra Narang, BMEDSci, MBBCH, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1-4
Awards & highlights
Study Summary
This trial is testing HHF as a possible treatment for OSA, which is a sleep disorder.
Eligible Conditions
- Obstructive Sleep Apnea
- Obesity
- Central Sleep Apnea
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1-4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1-4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP
Secondary outcome measures
Comparative COMFORT scales with HHF and CPAP.
Trial Design
2Treatment groups
Active Control
Group I: ObeseActive Control1 Intervention
Obese subjects ages 10-18 years with OSA will be recruited from sleep clinic. As per standard clinic care, once a subject is diagnosed with OSA on a PSG they are reviewed in sleep clinic to discuss CPAP therapy. Families will be approached to participate in this study during the subject's regularly scheduled clinical visit. Obese subjects meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in the study.
Group II: CMCActive Control1 Intervention
As per current standard clinical care, CMC diagnosed with moderate to severe OSA following a clinically indicated baseline PSG who have had a previous adenotonsillectomy or who are not considered candidates for surgery are reviewed in sleep clinic to discuss the prescription of CPAP for OSA. CMC subjects' meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in this study.
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Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,773 Total Patients Enrolled
Indra Narang, BMEDSci, MBBCH, MDPrincipal InvestigatorThe Hospital for Sick Children
1 Previous Clinical Trials
102 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study recruiting participants currently?
"As published on clinicaltrials.gov, enrollment for this trial is still open to the public. The medical experiment was first posted in March of 2019 and its details were last edited April 25th 2022."
Answered by AI
What is the aggregate number of participants in this experiment?
"Affirmative. According to clinicaltrials.gov, the trial was initially posted on March 1st 2019 and last revised April 25th 2022; actively recruiting 36 individuals from a single site."
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