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Nutritional Rehabilitation and Sleep Apnea in the Obese

NCT ID: NCT03857191

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

396 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-22

Study Completion Date

2022-05-16

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.

Conditions

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Obese Sleep Apnea, Obstructive

Keywords

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obesity sleep apnea hypertension type 2 diabetes CPAP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients already treated for OSA

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

Nutritional psychocomportemental rehabilitation

Intervention Type DIETARY_SUPPLEMENT

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

Nutritional psychocomportemental rehabilitation

Intervention Type DIETARY_SUPPLEMENT

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

Nutritional psychocomportemental rehabilitation

Intervention Type DIETARY_SUPPLEMENT

Nutritional psychocomportemental rehabilitation

Interventions

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Nutritional psychocomportemental rehabilitation

Nutritional psychocomportemental rehabilitation

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Éthique et Santé

INDUSTRY

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis PEPIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Grenoble Alpes University Hospital

Locations

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Chu Grenoble Alpes

Grenoble, , France

Site Status

Countries

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France

References

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Bailly S, Fabre O, Cals-Maurette M, Pantagis L, Terrail R, Legrand R, Astrup A, Pepin JL. Impact of a Weight-Loss Rehabilitation Program on Sleep Apnea Risk and Subjective Sleepiness in Patients with Overweight/Obesity: The DietSleep Study. J Clin Med. 2022 Nov 22;11(23):6890. doi: 10.3390/jcm11236890.

Reference Type RESULT
PMID: 36498465 (View on PubMed)

Other Identifiers

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2018-A02617-48

Identifier Type: OTHER

Identifier Source: secondary_id

38RC18.267

Identifier Type: -

Identifier Source: org_study_id