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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.
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:
Follow-up:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Bariatric surgery includes (but is not limited to)
Bariatric surgery is considered a treatment option
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 months |
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Inclusion Criteria:
Any informed person who is
Exclusion Criteria:
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Eligible patients from CHU St Pierre hospital setting
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie BRUYNEEL, Prof. | Contact | +3225353686 | marie.bruyneel@stpierre-bru.be | |
| Ionela BOLD, MD | Contact | +3225353686 | ionela.bold@stpierre-bru.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU St Pierre | Recruiting | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 9 months |
| Ionela Bold | Recruiting | Brussels | 1000 | Belgium |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |