Rehabilitation Program as an Alternative Therapy for Moderate to Severe Obstructive Sleep Apnea Syndrome

NCT01362777 | Completed Phase 3

• 1 other identifier: UF062007
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of traffic accidents but also other cognitive disorders with significant impact on quality of life. OSAS generates oxidative stress, inflammation and resistance to insulin and other systemic metabolic dysregulation of many whose levels are correlated with the severity of the disease. Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept and/or poorly tolerated, limiting its effectiveness. Weight loss and regular physical activity are clearly recommended but rarely done in clinical practice. A few studies have applied to study the effects of rehabilitation training (REE) on the sleep apnea patients and have shown an improvement in sleep quality, reduction of awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their methodology was questionable, and the number of patients included was too low. The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program comprising educational activities, dietary management and individualized exercise training (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL). This IET program (24 sessions during 4 weeks) could also help to improve many metabolic dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk). Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may play a role in enabling a better control of ventilation in these patients.

Conditions

Sleep Apnea, Obstructive; Metabolic Syndrome

Keywords

Obstructive Sleep Apnea/Hypopnea Syndrome; Exercise training program; Inflammation; Oxidative Stress; Resistance to insulin

Outcome Measures

Primary Outcomes (1)

• Delta of the Apnea/Hypopnea Index (AHI)between the two arms

  Comparing Delta of AHI 4 weeks (J0/J28) after starting the intervention (assessed by polysomnography at inclusion - end monitoring) between the two arms using the Student t test or Wilcoxon test if the distribution is not Gaussian.

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

In-Patient Rehabilitation

EXPERIMENTAL

Sessions of rehabilitation contains : * Individualized exercise training * Educational activities * Dietary advices

Behavioral: In-patient rehabilitation

Educational activities alone

ACTIVE COMPARATOR

Out-patient control arm contains only : -Educational activities

Behavioral: Educational activities alone

Interventions

In-patient rehabilitation BEHAVIORAL

Individualized exercise training (IET): Duration : 24 sessions during 4 weeks IET session (2h) contains: * 15' start warming up muscles * 30' muscle strengthening exercise for arms and abdominal muscles * 45' individualized cycle ergometer endurance training to the ventilatory threshold heart rate measured on the cardiopulmonary exercise test. * 15' stretching * 15' postural, movement and balance exercises IET session was controlled by a professional instructor using heart rate monitoring. Duration, intensity and attendance were recorded in a logbook. Educational activities (20h): the 8 themes are comparable to comparator arm. Dietary management: was performed by dietician to ensure that energy intakes are adjusted to energy expenditure. No restrictive diet was prescribe.

Also known as: Individualized exercise training, Educational activities, Dietary management

In-Patient Rehabilitation

Educational activities alone BEHAVIORAL

Educational activities alone contains 10 sessions lasting 1:00 with 8 themes : * Physiological mechanisms of apneas/hypopneas * Effects of apneas/hypopneas on health (vascular morbidity/mortality and sleepiness) * Beneficials effects of CPAP and/or advanced mandibular orthosis * Description of sleep stages and physiological roles of sleep * Known effects of exercise on sleep and metabolism * Importance of good nutritional status and sleep hygiene on quality of life * How to apply theses lessons of rehabilitation in daily life

Also known as: Educational activities

Educational activities alone

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe Obstructive Sleep Apnea Hypopnea Syndrome (AHI \> 15/h)
• Sedentary patient (Activity Voorrips Questionnary score \< 9,4)

You may not qualify if:

• OSAS already treated by CPAP or other therapy (OAM,...)
• BMI \> 40/m²
• Hypnotic and sedative medications
• Cranio-facial malformation
• Obstructive respiratory disease (COPD, asthma,...)
• Instable heart ischemic disease and all

Sponsors & Collaborators

• 5 Santé: lead
• A.E.R.O.B.I.E.: collaborator
• INSERM U1046 Physiologie et médecine expérimentale du cœur et des muscles: collaborator

Study Sites (1)

Clinique du souffle "La Solane"

Osséja, 66340, France

Location

Related Publications (1)

• Desplan M, Mercier J, Sabate M, Ninot G, Prefaut C, Dauvilliers Y. A comprehensive rehabilitation program improves disease severity in patients with obstructive sleep apnea syndrome: a pilot randomized controlled study. Sleep Med. 2014 Aug;15(8):906-12. doi: 10.1016/j.sleep.2013.09.023. Epub 2014 Apr 1.

  PMID: 24947878 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Metabolic Syndrome; Inflammation

Interventions

Diet

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Matthieu DESPLAN, MD

  CHU Montpellier, INSERM U1046

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docteur M.Desplan (MD)

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: May 30, 2011
• Study Start: November 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

FR (1)