Skip to main content
OpenTrials
Completed

NCT Number: NCT03857191

Nutritional Rehabilitation and Sleep Apnea in the Obese

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional psychocomportemental rehabilitation

Dietary Supplement

Nutritional psychocomportemental rehabilitation

Primary outcomes

  1. Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation

    Time frame: 25 weeks

    Berlin questionnaire score of patients will be compared before and after weight loss (if any) by nutritional psychocomportemental reeducation

Secondary outcomes

  1. Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation

    Time frame: 25 weeks

    Epworth sleepiness score of patients will be compared before and after weight loss by nutritional psychocomportemental rehabilitation

  2. Weight loss according to OSA status

    Time frame: 25 weeks

    Weight loss will be compared according to the somnolence and/or OSA risk defined by Berlin score

  3. Change in Blood pressure according to OSA status

    Time frame: 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

  4. Change in Medication use according to OSA status

    Time frame: 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

  5. To assess the effect of Weight loss on OSA

    Time frame: 25 weeks

    To determine the percentage of patients stopping CPAP treatment after weight loss

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Groupe Éthique et Santé

Registry information

Official study title

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

Acronym: DIETSLEEP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2019
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.