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Nutritional Rehabilitation and Sleep Apnea in the Obese

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03857191
Acronym
DIETSLEEP
Enrollment
396
Registered
2019-02-27
Start date
2019-03-22
Completion date
2022-05-16
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Sleep Apnea, Obstructive

Keywords

obesity, sleep apnea, hypertension, type 2 diabetes, CPAP

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.

Interventions

DIETARY_SUPPLEMENTNutritional psychocomportemental rehabilitation

Nutritional psychocomportemental rehabilitation

Sponsors

Groupe Éthique et Santé
CollaboratorINDUSTRY
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation25 weeksBerlin questionnaire score of patients will be compared before and after weight loss (if any) by nutritional psychocomportemental reeducation

Secondary

MeasureTime frameDescription
Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation25 weeksEpworth sleepiness score of patients will be compared before and after weight loss by nutritional psychocomportemental rehabilitation
Weight loss according to OSA status25 weeksWeight loss will be compared according to the somnolence and/or OSA risk defined by Berlin score
Change in Blood pressure according to OSA status25 weeksBlood pressure reduction between the beginning and the end of the dietary program will be compared according to OSA risk defined by Berlin score
Change in Medication use according to OSA status25 weeksChange in the number of antihypertensive, antidiabetic and lipid lowering drug use will be compared according to the change in Berlin questionnaire score
To assess the effect of Weight loss on OSA25 weeksTo determine the percentage of patients stopping CPAP treatment after weight loss

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026