Nutritional Rehabilitation and Sleep Apnea in the Obese (DIETSLEEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Obese
• Intervention / Treatment: Dietary supplement: Nutritional 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.

• Study Type: Observational
• Enrollment (Actual): 396

Contacts and Locations

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • CHU Grenoble Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients already treated for OSA; The first group involves patients already diagnosed and treated for sleep apnea that will follow the nutritional psychocomportemental rehabilitation	Dietary supplement: Nutritional psychocomportemental rehabilitation; Nutritional psychocomportemental rehabilitation
Patients with a high OSA risk; 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; Nutritional psychocomportemental rehabilitation
Patients with a low OSA risk; 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; Nutritional psychocomportemental rehabilitation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Groupe Ethique & santé
• Investigators: Principal Investigator: Jean-Louis PEPIN, MD, PhD, Grenoble Alpes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: obesity; hypertension; type 2 diabetes; CPAP; sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 38RC18.267; 2018-A02617-48 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No