Nutritional Rehabilitation and Sleep Apnea in the Obese (DIETSLEEP)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Obese; Sleep Apnea, Obstructive

Treatments: Dietary Supplement: Nutritional psychocomportemental rehabilitation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03857191

38RC18.267

2018-A02617-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

396 participants in 3 patient groups

Patients already treated for OSA

Description:

The first group involves patients already diagnosed and treated for sleep apnea that will follow the nutritional psychocomportemental rehabilitation

Treatment:

Dietary Supplement: Nutritional psychocomportemental rehabilitation

Patients with a high OSA risk

Description:

This group concerns patients with a high OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation

Treatment:

Dietary Supplement: Nutritional psychocomportemental rehabilitation

Patients with a low OSA risk

Description:

This group concerns patients with a low OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation

Treatment:

Dietary Supplement: Nutritional psychocomportemental rehabilitation