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

Sleep Apnea, Obstructive Clinical Trial

— OBESOMAC  

Official title:

Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588469
• Other study ID #: P/2015/250
• Status: Completed
• Phase: N/A
• First received: July 22, 2015
• Last updated: January 22, 2018
• Start date: August 27, 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Pediatric Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Interventional group
Venous compression leads to beneficial fluid regulation in OSA participants 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.
• Control group
Standard obesity care with physical activity program

Locations

Country	Name	City	State
France	Centre de soins de suite et de réadaptation La Beline	Salins-les-Bains

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Obstructive sleep apnea severity at 3 months.	Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Upper airway resistances	upper airway resistance will be assessed by acoustic method	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Fluid shift	fluid shift will be assessed by bioimpedance analysis	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Calf and neck circumferences	Calf and neck circumferences will be assessed with nonelastic tape	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Calf and neck circumferences	Calf and neck circumferences will be assessed by plethysmography	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Anthropometric parameters	weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Body composition	fat mass, fat free mass ( by bioimpedance analysis)	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Pulmonary function during exercise	Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Metabolic responses	Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Hormonal responses	Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)	This study includes 2 assessments : baseline (T0) and 3 months (T3)
Secondary	Inflammatory responses	C-reactive protein (ELISA and RIA technics)	This study includes 2 assessments : baseline (T0) and 3 months (T3)