Nutritional Rehabilitation and Sleep Apnea in the Obese

Sleep Apnea, Obstructive Clinical Trial

— DIETSLEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857191
• Other study ID #: 38RC18.267
• Secondary ID: 2018-A02617-48
• Status: Completed
• Start date: March 22, 2019
• Est. completion date: May 16, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: May 16, 2022
• Est. primary completion date: April 11, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obese
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Dietary Supplement:
• Nutritional psychocomportemental rehabilitation
Nutritional psychocomportemental rehabilitation

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble Cedex 9

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Groupe Ethique & santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To assess the effect of Weight loss on OSA	To determine the percentage of patients stopping CPAP treatment after weight loss	25 weeks