Changes in Body Fat and Morphologic Characteristics Associated With OSA Resolution After Bariatric Surgery

NCT ID: NCT05315752

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2026-12-31

Brief 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, 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:

1. Anthropometric characteristics: body mass index (BMI), neck circumference, waist/hip ratio, fat mass + lean mass (bioelectrical impedance measurements),

2. APAP treatment characteristics, mean APAP pressure, 95th percentile APAP pressure, APAP adherence.

Follow-up:

1. 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).

2. 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Bariatric 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

• Cognitive impairment - language barrier

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Marie Bruyneel

Head of pneumology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU St Pierre

Brussels, , Belgium

Site Status: RECRUITING

Ionela Bold

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Marie BRUYNEEL, Prof.

Role: CONTACT

marie.bruyneel@stpierre-bru.be

+3225353686

Ionela BOLD, MD

Role: CONTACT

ionela.bold@stpierre-bru.be

+3225353686

Facility Contacts

Ionela Bold, MD

Role: primary

ionela.bold@stpierre-bru.be

+3225353686

Nathalie Y Pauwen, MSc

Role: backup

nathalie.pauwen@ulb.be

+32460955869

Ionela Bold

Role: primary

ionela.bold@stpierre-bru.be

+3225353686

Nathalie Y Pauwen

Role: backup

nathalie.pauwen@ulb.be

+32460955869

Other Identifiers

IO-BRUY-CE/220209

Identifier Type: -

Identifier Source: org_study_id