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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362777
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : September 20, 2011
Sponsor:
Collaborators:
A.E.R.O.B.I.E.
INSERM U1046 Physiologie et médecine expérimentale du cœur et des muscles
Information provided by (Responsible Party):
matthieu.desplan, 5 Santé

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Metabolic Syndrome Behavioral: In-patient rehabilitation Behavioral: Educational activities alone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: In-Patient Rehabilitation

Sessions of rehabilitation contains :

  • Individualized exercise training
  • Educational activities
  • Dietary advices
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.

Other Names:
  • Individualized exercise training
  • Educational activities
  • Dietary management

Active Comparator: Educational activities alone

Out-patient control arm contains only :

-Educational activities

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
Other Name: Educational activities




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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France
Clinique du souffle "La Solane"
Osseja, France, 66340
Sponsors and Collaborators
5 Santé
A.E.R.O.B.I.E.
INSERM U1046 Physiologie et médecine expérimentale du cœur et des muscles
Investigators
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Principal Investigator: Matthieu DESPLAN, MD CHU Montpellier, INSERM U1046
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: matthieu.desplan, Docteur M.Desplan (MD), 5 Santé
ClinicalTrials.gov Identifier: NCT01362777    
Other Study ID Numbers: UF062007
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011
Keywords provided by matthieu.desplan, 5 Santé:
Obstructive Sleep Apnea/Hypopnea Syndrome
Exercise training program
Inflammation
Oxidative Stress
Resistance to insulin
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases