Nutritional Rehabilitation and Sleep Apnea in the Obese

NCT03857191 | Completed

• 2 other identifiers: 38RC18.2672018-A02617-48
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Sleep Apnea, Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation

  25 weeks

• Weight loss according to OSA status

  25 weeks

• Change in Blood pressure according to OSA status

  25 weeks

• Change in Medication use according to OSA status

  25 weeks

• To assess the effect of Weight loss on OSA

  25 weeks

Study Arms (3)

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

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

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

Interventions

Nutritional psychocomportemental rehabilitation DIETARY_SUPPLEMENT

Nutritional psychocomportemental rehabilitation

Patients already treated for OSA; Patients with a high OSA risk; Patients with a low OSA risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Overweight and obese patients

You may qualify if:

• 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

You may not qualify if:

• \- Subjects covered by articles L1121-5 to L1121-8 of French law

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Groupe Éthique et Santé: collaborator

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (1)

• 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.

  PMID: 36498465 RESULT

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jean-Louis PEPIN, MD, PhD

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: March 22, 2019
• Primary Completion: April 11, 2022
• Study Completion: May 16, 2022
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (1)