ObeseDIETSLEEPNCT03857191
Nutritional Rehabilitation and Sleep Apnea in the Obese
An observational study of Obese and Sleep Apnea, Obstructive, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obese, Sleep Apnea, Obstructive
- What is being tested?
- Nutritional psychocomportemental rehabilitation
- How many people
- 396 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2019to 16 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Overweight and obese patients
Who may be able to join
- 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
Who cannot join
- Subjects covered by articles L1121-5 to L1121-8 of French law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obese, Sleep Apnea, Obstructive
- Being tested
- Nutritional psychocomportemental rehabilitation
- Keywords
- obesity, sleep apnea, hypertension, type 2 diabetes, CPAP
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional psychocomportemental rehabilitationDietary supplement
Nutritional psychocomportemental rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Patients already treated for OSA | The first group involves patients already diagnosed and treated for sleep apnea that will follow the nutritional psychocomportemental rehabilitation Receives: 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 Receives: 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 Receives: Dietary Supplement: Nutritional psychocomportemental rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 25 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 25 weeks
To assess the effect of Weight loss on OSA
To determine the percentage of patients stopping CPAP treatment after weight loss
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start22 Mar 2019
- Primary completion11 Apr 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Éthique et Santé
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, MD, PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857191
- Sponsor's protocol ID
- 38RC18.267
- Other IDs
- 2018-A02617-48
- Acronym
- DIETSLEEP
- Status last verified
- Dec 2025
- First submitted
- 20 Feb 2019
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36498465
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Psychocomportemental Reeducation, Sleep Apnea and Comorbidities in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT03857191
- Acronym / sponsor ID
- DIETSLEEP / 38RC18.267
- Conditions
- Obese, Sleep Apnea, Obstructive
- Keywords
- obesity, sleep apnea, hypertension, type 2 diabetes, CPAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Groupe Éthique et Santé
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients already treated for OSA | – | Dietary Supplement: Nutritional psychocomportemental rehabilitationThe first group involves patients already diagnosed and treated for sleep apnea that will follow the nutritional psychocomportemental rehabilitation |
| Patients with a high OSA risk | – | Dietary Supplement: Nutritional psychocomportemental rehabilitationThis group concerns patients with a high OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation |
| Patients with a low OSA risk | – | Dietary Supplement: Nutritional psychocomportemental rehabilitationThis group concerns patients with a low OSA risk according to their Berlin questionnaire score that will follow the nutritional psychocomportemental rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Overweight and obese patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects covered by articles L1121-5 to L1121-8 of French law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional psychocomportemental rehabilitationNutritional psychocomportemental rehabilitation | Dietary supplement | Patients already treated for OSA, Patients with a high OSA risk, Patients with a low OSA risk |
Primary outcome
Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation
Time frame: 25 weeks
Berlin questionnaire score of patients will be compared before and after weight loss (if any) by nutritional psychocomportemental reeducation
5 secondary outcomes
Difference in daytime sleepiness before and after nutritional and psychocomportemental rehabilitation
Time frame: 25 weeks
Weight loss according to OSA status
Time frame: 25 weeks
Change in Blood pressure according to OSA status
Time frame: 25 weeks
Change in Medication use according to OSA status
Time frame: 25 weeks
To assess the effect of Weight loss on OSA
Time frame: 25 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Results publication: PubMed 36498465Bailly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN, MD, PhD principal investigator
Grenoble Alpes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obese and Sleep Apnea, Obstructive, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in OSA risk before and after nutritional and psychocomportemental rehabilitation (time frame: 25 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.