Nutritional Rehabilitation and Sleep Apnea in the Obese
- Conditions
- ObeseSleep Apnea, Obstructive
- Interventions
- Dietary Supplement: Nutritional psychocomportemental rehabilitation
- Registration Number
- NCT03857191
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 396
- 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
- Subjects covered by articles L1121-5 to L1121-8 of French law
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with a high OSA risk Nutritional psychocomportemental rehabilitation This group concerns patients with a high OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation Patients already treated for OSA Nutritional psychocomportemental rehabilitation The first group involves patients already diagnosed and treated for sleep apnea that will follow the nutritional psychocomportemental rehabilitation Patients with a low OSA risk Nutritional psychocomportemental rehabilitation This group concerns patients with a low OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation
- Primary Outcome Measures
Name Time Method Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation 25 weeks Berlin questionnaire score of patients will be compared before and after weight loss (if any) by nutritional psychocomportemental reeducation
- Secondary Outcome Measures
Name Time Method Weight loss according to OSA status 25 weeks Weight loss will be compared according to the somnolence and/or OSA risk defined by Berlin score
Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation 25 weeks Epworth sleepiness score of patients will be compared before and after weight loss by nutritional psychocomportemental rehabilitation
Change in Medication use according to OSA status 25 weeks Change in the number of antihypertensive, antidiabetic and lipid lowering drug use will be compared according to the change in Berlin questionnaire score
Change in Blood pressure according to OSA status 25 weeks Blood pressure reduction between the beginning and the end of the dietary program will be compared according to OSA risk defined by Berlin score
To assess the effect of Weight loss on OSA 25 weeks To determine the percentage of patients stopping CPAP treatment after weight loss
Trial Locations
- Locations (1)
Chu Grenoble Alpes
🇫🇷Grenoble Cedex 9, France