Rehabilitation Program as an Alternative Therapy for Moderate to Severe Obstructive Sleep Apnea Syndrome (Rehsolvas)
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|ClinicalTrials.gov Identifier: NCT01362777|
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : September 20, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Metabolic Syndrome||Behavioral: In-patient rehabilitation Behavioral: Educational activities alone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of an In-Patient Individualized Rehabilitation Program on Severity and Symptoms of Obstructive Sleep Apnea Syndrome (OSAS):Results of a Randomized Controlled Pilot Study|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||August 2010|
Experimental: In-Patient Rehabilitation
Sessions of rehabilitation contains :
Behavioral: In-patient rehabilitation
Individualized exercise training (IET):
Duration : 24 sessions during 4 weeks
IET session (2h) contains:
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.
Active Comparator: Educational activities alone
Out-patient control arm contains only :
Behavioral: Educational activities alone
Educational activities alone contains 10 sessions lasting 1:00 with 8 themes :
Other Name: Educational activities
- Delta of the Apnea/Hypopnea Index (AHI)between the two arms [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362777
|Clinique du souffle "La Solane"|
|Osseja, France, 66340|
|Principal Investigator:||Matthieu DESPLAN, MD||CHU Montpellier, INSERM U1046|