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Completed

NCT Number: NCT02588469

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

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.

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Key information

Conditions

Pediatric Obesity Apnea Behavior Body Weight Dyssomnias Motor Activity Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de soins de suite et de réadaptation La Beline

Salins-les-Bains, 39110, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interventional group

Other

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

Other

Standard obesity care with physical activity program

Primary outcomes

  1. Change from Obstructive sleep apnea severity at 3 months.

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

    Obstructive Sleep Apnea change will be assessed with polysomnography system at baseline and after three months

Secondary outcomes

  1. Upper airway resistances

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

    upper airway resistance will be assessed by acoustic method

  2. Fluid shift

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

    fluid shift will be assessed by bioimpedance analysis

  3. Calf and neck circumferences

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

    Calf and neck circumferences will be assessed with nonelastic tape

  4. Calf and neck circumferences

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

    Calf and neck circumferences will be assessed by plethysmography

  5. Anthropometric parameters

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

    weight, height, waist and hip circumferences (body weight scale, standing stadiometer and non-elastic tape)

  6. Body composition

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

    fat mass, fat free mass ( by bioimpedance analysis)

  7. Pulmonary function during exercise

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

    Incremental maximal exercise in cycling ergometer with respiratory gas assessment (metamax)

  8. Metabolic responses

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

    Glucose, LDL-Cholesterol, HDL-Cholesterol, Total Cholesterol, Triglycerides (ELISA and RIA technics)

  9. Hormonal responses

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

    Insulin, leptin, adiponectin, catecholamines (ELISA and RIA technics)

  10. Inflammatory responses

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

    C-reactive protein (ELISA and RIA technics)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: OBESOMAC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2015
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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