Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatri… (NCT05315752) | Clinical Trial Compass
RecruitingNot Applicable
Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery
Belgium60 participantsStarted 2022-04-22
Plain-language summary
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the resolution of OSA is better than the relationship between these biometric changes and BMI reduction.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Any informed person who is
* eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity (BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle adaptations (balanced diet, physical activity) AND
* with diagnosed obstructive sleep apnoea (OSA) (AHI \> 15/hr on polysomnography) AND
* requiring treatment with Continuous Positive Air Pressure (CPAP)
Exclusion Criteria:
* Cognitive impairment - language barrier
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Timeframe: 2 months
2
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Timeframe: 6 months
3
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Timeframe: 12 months
Trial details
NCT IDNCT05315752
SponsorCentre Hospitalier Universitaire Saint Pierre