ObesityNCT05315752
Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery
An observational study of Obesity and Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
Trial summary
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesBelgium
- Study dates
- 22 Apr 2022to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients from CHU St Pierre hospital setting
Who may be able to join
- Any informed person who is
- eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity (BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle adaptations (balanced diet, physical activity) AND
- with diagnosed obstructive sleep apnoea (OSA) (AHI > 15/hr on polysomnography) AND
- requiring treatment with Continuous Positive Air Pressure (CPAP)
Who cannot join
- Cognitive impairment - language barrier
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
CHU St Pierre
Brussels, 1000
Ionela Bold, MD, +3225353686, ionela.bold@stpierre-bru.be
Nathalie Y Pauwen, MSc, +32460955869, nathalie.pauwen@ulb.be
- Recruiting
Ionela Bold
Brussels, 1000
Ionela Bold, +3225353686, ionela.bold@stpierre-bru.be
Nathalie Y Pauwen, +32460955869, nathalie.pauwen@ulb.be
About this study
Official title: Changes in Body Fat and Morphologic Characteristics Associated With Obstructive Sleep Apnea (OSA) Resolution After Bariatric Surgery
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the resolution of OSA is better than the relationship between these biometric changes and BMI reduction.
Read the detailed description
Investigators are concerned about the high prevalence of Obstructive Sleep Apnoea syndrome (OSA) in the bariatric population. Postoperatively, there is a high rate of recovery from OSA. Indeed, investigators know from previous reports that weight loss is a very effective, but time consuming, strategy for treating OSA. Patients are therefore treated with CPAP (Continuous Positive Airway Pressure) while waiting for weight loss. In a recent meta-analysis, which focused on the effect of weight loss achieved through lifestyle interventions in 618 overweight and obese patients, the apnea-hypopnea index (AHI) decreased by an amount of 16/h for an average weight loss of 14 kg (1). However, the majority of patients are not able to maintain weight loss in the long term, and weight gain is associated with recurrence/aggravation of OSAS (2). Nowadays, bariatric surgery is a common strategy to achieve sustained and significant weight loss in obese patients. Sarkhosh et al. examined the impact of bariatric surgery (restrictive procedures, with a mild malabsorption component, or largely malabsorptive procedures) on sleep apnoea in 13,900 patients. Depending on the procedure, improvement or resolution of OSAS was achieved in 78-90% of patients (3).
Prospective longitudinal postoperative follow-up study : inclusion of patients who had scheduled bariatric surgery, diagnosed with OSA, AHI > 15 (polysomnography), treated with self-controlled CPAP (APAP), under remote monitoring;
Baseline measures:
- Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + lean mass (bioelectrical impedance measurements),
- APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP adherence.
Follow-up:
- The 2-month follow-up: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + fat-free mass (bioelectrical impedance measurements), mean APAP pressure, 95th percentile APAP pressure, APAP adherence. To assess potential regression of OSA with weight loss: home polygraphy after 4 nights off APAP (4).
- Six-month and 12-month follow-up: same as at 2 months. Follow-up stops in case of a polygraph showing an AHI <10, allowing APAP treatment to be stopped.
- Conditions
- Obesity, Obstructive Sleep Apnea
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery includes (but is not limited to)
- Gastric bypass: surgical bypass of the entire stomach, duodenum and approximately 1 m of the proximal small intestine
- Sleeve: a large part of the stomach is removed laparoscopically, the open vertical edges are put back in place to leave a sleeve-like tube.
Bariatric surgery is considered a treatment option
- for patients with a BMI >40 kg/m 2 , assuming the patient has previously participated successfully in a group weight management programme (weight loss >7%) or
- for patients with a BMI of 35-40 kg/m 2 when the obesity is associated with type 2 diabetes or hypertension, or OAS (with CPAP therapy) or severe musculoskeletal disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
Measured: 2 months
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
Measured: 6 months
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
Measured: 12 months
Secondary outcomes (9)
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
Comparison of (1) the correlation between neck circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between neck circumference reduction and BMI reduction
Measured: 2 months
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
Comparison of (1) the correlation between neck circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between neck circumference reduction and BMI reduction
Measured: 6 months
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
Comparison of (1) the correlation between neck circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between neck circumference reduction and BMI reduction
Measured: 12 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
Comparison of (1) the correlation between hip circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between hip circumference reduction and BMI reduction
Measured: 2 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
Comparison of (1) the correlation between hip circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between hip circumference reduction and BMI reduction
Measured: 6 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
Comparison of (1) the correlation between hip circumference reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between hip circumference reduction and BMI reduction
Measured: 12 months
Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction
Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction
Measured: 2 months
Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction
Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction
Measured: 6 months
Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction
Comparison of (1) the correlation between lean mass reduction and OAS resolution (AHI<10/hour on polysomnography) and (2) the correlation between lean mass reduction and BMI reduction
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start22 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315752
- Sponsor's protocol ID
- IO-BRUY-CE/220209
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Body Fat and Morphologic Characteristics Associated With Obstructive Sleep Apnea (OSA) Resolution After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05315752
- Acronym / sponsor ID
- IO-BRUY-CE/220209
- Conditions
- Obesity, Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2022 (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.
Prospective study with inclusion of bariatric surgery candidates with diagnosed Obstructive Sleep Apnea and requiring treatment with Continuous Positive Air Pressure, aiming to evaluate at 2-6-12 months after bariatric surgery whether the relationship between biometric changes (reduction in neck circumference, height, waist/hip ratio, and fat and lean mass) and the resolution of OSA is better than the relationship between these biometric changes and BMI reduction.
Detailed description
Investigators are concerned about the high prevalence of Obstructive Sleep Apnoea syndrome (OSA) in the bariatric population. Postoperatively, there is a high rate of recovery from OSA. Indeed, investigators know from previous reports that weight loss is a very effective, but time consuming, strategy for treating OSA. Patients are therefore treated with CPAP (Continuous Positive Airway Pressure) while waiting for weight loss. In a recent meta-analysis, which focused on the effect of weight loss achieved through lifestyle interventions in 618 overweight and obese patients, the apnea-hypopnea index (AHI) decreased by an amount of 16/h for an average weight loss of 14 kg (1). However, the majority of patients are not able to maintain weight loss in the long term, and weight gain is associated with recurrence/aggravation of OSAS (2). Nowadays, bariatric surgery is a common strategy to achieve sustained and significant weight loss in obese patients. Sarkhosh et al. examined the impact of bariatric surgery (restrictive procedures, with a mild malabsorption component, or largely malabsorptive procedures) on sleep apnoea in 13,900 patients. Depending on the procedure, improvement or resolution of OSAS was achieved in 78-90% of patients (3).
Prospective longitudinal postoperative follow-up study : inclusion of patients who had scheduled bariatric surgery, diagnosed with OSA, AHI > 15 (polysomnography), treated with self-controlled CPAP (APAP), under remote monitoring;
Baseline measures:
- Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + lean mass (bioelectrical impedance measurements),
- APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP adherence.
Follow-up:
- The 2-month follow-up: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + fat-free mass (bioelectrical impedance measurements), mean APAP pressure, 95th percentile APAP pressure, APAP adherence. To assess potential regression of OSA with weight loss: home polygraphy after 4 nights off APAP (4).
- Six-month and 12-month follow-up: same as at 2 months. Follow-up stops in case of a polygraph showing an AHI <10, allowing APAP treatment to be stopped.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients from CHU St Pierre hospital setting
Key inclusion criteria (4 listed)
- Any informed person who is
- eligible for bariatric surgery: with severe obesity (BMI≥35-40) or morbid obesity (BMI≥40), with co-morbidities, who have not lost enough weight with prior lifestyle adaptations (balanced diet, physical activity) AND
- with diagnosed obstructive sleep apnoea (OSA) (AHI > 15/hr on polysomnography) AND
- requiring treatment with Continuous Positive Air Pressure (CPAP)
Key exclusion criteria (1 listed)
- Cognitive impairment - language barrier
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 |
|---|---|---|
| Bariatric surgeryBariatric surgery includes (but is not limited to) * Gastric bypass: surgical bypass of the entire stomach, duodenum and approximately 1 m of the proximal small intestine * Sleeve: a large part of the stomach is removed laparoscopically, the open vertical edges are put back in place to leave a sleeve-like tube. Bariatric surgery is considered a treatment option * for patients with a BMI >40 kg/m 2 , assuming the patient has previously participated successfully in a group weight management programme (weight loss >7%) or * for patients with a BMI of 35-40 kg/m 2 when the obesity is associated with type 2 diabetes or hypertension, or OAS (with CPAP therapy) or severe musculoskeletal disease | Procedure or surgery | – |
Primary outcome
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Time frame: 2 months
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Time frame: 6 months
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI
Time frame: 12 months
Comparison of (1) the correlation between waist circumference reduction and resolution of OAS (AHI<10/hour on polysomnography) and (2) the correlation between waist circumference reduction and BMI reduction
9 secondary outcomes
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
Time frame: 2 months
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
Time frame: 6 months
Comparison of (1) the correlation between neck circumference reduction and OAS resolution and (2) the correlation between neck circumference reduction and BMI reduction
Time frame: 12 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
Time frame: 2 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
Time frame: 6 months
Comparison of (1) the correlation between hip circumference reduction and OAS resolution and (2) the correlation between hip circumference reduction and BMI reduction
Time frame: 12 months
Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction
Time frame: 2 months
Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction
Time frame: 6 months
Comparison of (1) the correlation between lean mass reduction and OAS resolution and (2) the correlation between lean mass reduction and BMI reduction
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie BRUYNEEL, Prof. (+3225353686, marie.bruyneel@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of (1) the relationship between waist circumference changes and resolution of obstructive sleep apnea and (2) the relationship between the changes in waist circumference and BMI (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2024.