Clinical trial NCT02588469: Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With OSA
Official title: Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Sleep Apnea, Obstructive
Keywords: pediatric obesity
obstructive sleep apnea
physical exercise
compression socks
rostral fluid shift
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Obesity is an important factor of OSA development in children and teenagers, and physical activity is a relevant alternative to promote OSA decrease with ou without weight loss.

Physical activity, beyond the improvement of body composition and exercise cardiorespiratory capacity, restricts fluid retaining in the lower limb of the leg by the activation of musculovenous pump. Fluid retaining is involved in OSA severity because of nocturnal fluid shift from legs to rostral zone which promotes pharyngeal oedema development and upper airway collapsibility.

It has been previously shown that venous compression leads to beneficial fluid regulation in OSA subjects and appears as an efficient tool in OSA management.

To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Obstructive sleep apnea severity at 3 months.
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary outcomes:
measure: Upper airway resistances
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Fluid shift
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Calf and neck circumferences
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Calf and neck circumferences
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Anthropometric parameters
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Body composition
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Pulmonary function during exercise
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Metabolic responses
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Hormonal responses
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
measure: Inflammatory responses
timeFrame: This study includes 2 assessments : baseline (T0) and 3 months (T3)
Other outcomes:
Locations:
city: Salins-les-Bains
country: France
facility: Centre de soins de suite et de réadaptation La Beline
Study officials:
References:
citation: Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.
citation: Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.