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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
Sponsor study identifier
interventional
26
1 country
1
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
August 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
June 2010
Actual (reported)August 2010
Actual (reported)May 26, 2011
Actual (reported)May 30, 2011
Actual (reported)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
Sessions of rehabilitation contains : * Individualized exercise training * Educational activities * Dietary advices
Out-patient control arm contains only : -Educational activities
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.
Clinique du souffle "La Solane"
Osséja, 66340, France
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.
Matthieu DESPLAN, MD
CHU Montpellier, INSERM U1046
26 participants (actual enrollment reported by the registry).
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
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
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Primary Completion
June 2010
Actual (reported)Study Completion
August 2010
Actual (reported)Last Updated
September 20, 2011
Record last verified: 2011-09
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Source: ClinicalTrials.gov.
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