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

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

Interventions

BEHAVIORAL

In-patient rehabilitation

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.

BEHAVIORAL

Educational activities alone

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

Sponsors & Collaborators

• A.E.R.O.B.I.E.

  collaborator OTHER

• INSERM U1046 Physiologie et médecine expérimentale du cœur et des muscles

  collaborator UNKNOWN

• 5 Santé

  lead OTHER

Principal Investigators

• Matthieu DESPLAN, MD · CHU Montpellier, INSERM U1046

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2010-06-30

Completion

2010-08-31

Countries

• France

Study Locations