Nutritional Rehabilitation and Sleep Apnea in the Obese

Study Overview
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Brief Summary
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In obese patients, the prevalence of obstructive sleep apnea (OSA) is around 40% in men and 30% in women. Weight loss after bariatric surgery significantly improves OSA, with 75% of patients having a reduction in OSA severity or becoming non-apneic. We hypothesize a similar effect on OSA of nutritional and psychocomportemental rehabilitation for obese patients. However, we expect weight loss and blood pressure reduction to probably be lower in obese patients who have OSA and nutritional rehabilitation alone than in those who are treated for their OSA or are without OSA. To address this question, we will conduct an observational study on obese patients, treated or not for OSA, following nutritional and psychocomportemental rehabilitation.

Detailed Description
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In obese patients, OSA prevalence is around 40% in men and 30% in women. Being overweight or obese are independent risk factors for OSA, and the prevalence increases with body mass index (BMI). Weight loss after bariatric surgery is one treatment for OSA, 75% of patients having a reduction in OSA severity or becoming non-apneic. OSA and obesity both induce type 2 diabetes, hypertension and/or nonalcoholic fatty liver disease (NAFLD). A randomized study (Chirinos et al. NEJM 2014) demonstrated a better improvement in blood pressure, triglyceride levels or insulin resistance with weight loss alone or weight loss associated with continuous positive airway pressure (CPAP) than with CPAP alone. We hypothesize a similar effect of nutritional and psychocomportemental rehabilitation on OSA. However, weight loss and blood pressure improvements could be lesser in untreated OSA patients than in treated OSA or non-OSA patients. It has been demonstrated that bariatric surgery reduces medication use such as antihypertensive or antidiabetic drugs, and thus a secondary objective is to determine whether nutritional and psychocomportemental rehabilitation similarly reduces medication use by the overweight and obese.

Official Title
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Nutritional and Psychocomportemental Reeducation, Sleep Apnea and Comorbidities in Overweight and Obese Subjects

Conditions
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Obese, Sleep Apnea, Obstructive

Intervention / Treatment
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* Dietary Supplement: Nutritional psychocomportemental rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 25 kg/m² and/or waist circumference > 80 cm in women or 94 cm in men Patients registered to follow a nutritional psychocomportemental reeducation program with the Ethique et Santé group Exclusion Criteria: - Subjects covered by articles L1121-5 to L1121-8 of French law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients already treated for OSA<br>The first group involves patients already diagnosed and treated for sleep apnea that will follow the nutritional psychocomportemental rehabilitation | Dietary Supplement: Nutritional psychocomportemental rehabilitation<br>* Nutritional psychocomportemental rehabilitation<br>|
| Patients with a high OSA risk<br>This group concerns patients with a high OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation | Dietary Supplement: Nutritional psychocomportemental rehabilitation<br>* Nutritional psychocomportemental rehabilitation<br>|
| Patients with a low OSA risk<br>This group concerns patients with a low OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation | Dietary Supplement: Nutritional psychocomportemental rehabilitation<br>* Nutritional psychocomportemental rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation | Berlin questionnaire score of patients will be compared before and after weight loss (if any) by nutritional psychocomportemental reeducation | 25 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation | Epworth sleepiness score of patients will be compared before and after weight loss by nutritional psychocomportemental rehabilitation | 25 weeks | 
| Weight loss according to OSA status | Weight loss will be compared according to the somnolence and/or OSA risk defined by Berlin score | 25 weeks | 
| Change in Blood pressure according to OSA status | Blood pressure reduction between the beginning and the end of the dietary program will be compared according to OSA risk defined by Berlin score | 25 weeks | 
| Change in Medication use according to OSA status | Change in the number of antihypertensive, antidiabetic and lipid lowering drug use will be compared according to the change in Berlin questionnaire score | 25 weeks | 
| To assess the effect of Weight loss on OSA | To determine the percentage of patients stopping CPAP treatment after weight loss | 25 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, sleep apnea, hypertension, type 2 diabetes, CPAP