Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA (NCT02588469) | Clinical Trial Compass
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 range12 Years – 17 Years
SexALL
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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.
What they're measuring
1
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