CompletedNot Applicable

Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA

France32 participantsStarted 2015-08-27

Plain-language summary

The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.

Who can participate

Age range

12 Years – 17 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: * Obese adolescents (BMI \> 97th percentile), * patients aged from 12 to 17 years old, (born between 07/01/2003 and 09/01/1197), * enrolled in a pediatric obesity center with diet and physical activity programs and psychological management, * without observed tonsils hypertrophy (Mallampati and Friedman scores), * without contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography, * with physical activity certificate issued by a cardiologist * covered by the national insurance scheme of his/her legal representative, * having signed, as well as his(her) legal representative, the informed consent of participation. Exclusion Criteria: * Non obese adolescents (BMI \< 97th percentile) * patients aged under 12 or over 17 years old, * not enrolled in a pediatric obesity center with diet and physical activity programs and psychological management, * with observed tonsils hypertrophy (Mallampati and Friedman scores), * with contraindication for bioimpedance analysis, acoustic method and stain gauge plethysmography, * without physical activity certificate issued by a cardiologist * uncovered by the national insurance scheme of his/her legal representative, * not having signed, as well as his(her) legal representative, the informed consent of participation.

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

Change from Obstructive sleep apnea severity at 3 months.

Timeframe: This study includes 2 assessments : baseline (T0) and 3 months (T3)

Trial details

NCT IDNCT02588469

SponsorCentre Hospitalier Universitaire de Besancon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Pediatric Obesity trials