Obstructive Sleep Apnea, Predictors and Bariatric Surgery

Study Overview
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Brief Summary
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Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue and morning headache are symptoms of the disease which has severe health effect (Malhotra. et al. 2012) including increased mortality risk (Ensrud. et al. 2012) and effects on quality of life (Kuhn. et al. 2017). Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al. 2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease.

Detailed Description
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Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue and morning headache are symptoms of the disease which has severe health effect (Malhotra. et al. 2012) including increased mortality (Ensrud. et al. 2012) and effects on quality of life (Kuhn. et al. 2017). Hence, identifying and treat obstructive sleep apnea are important. Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz et. al. 2010, Edwards. et. al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease. Eighty-six patients with obesity have been recruited at the Catholic University hospital in Rome, Italy during 2012 when patients were enrolled during their evaluation for bariatric surgery. At baseline, the patient underwent fasting blood chemistry, anthropometric measurements and overnight polysomnography. The patients also underwent a 3 hour oral glucose tolerance test in order to determinate glucose tolerance (normal glucose tolerance, impaired glucose tolerance and type 2 diabetes mellitus). Patient then received treatment with bariatric surgery (gastric sleeve, biliopancreatic diversion or gastric bypass) during 2012-2013 or decided not to undergo bariatric surgery. Patient will undergo follow-up during 2016-2017 where fasting blood chemistry, anthropometric measurements and overnight polysomnography will be assessed. The patient will also undergo a 3 hour oral glucose tolerance test. The effects of bariatric surgery on obstructive sleep apnea will then be evaluated. Differences in the treatment effect between the different bariatric surgical procedures will be studied. Patients characteristics at baseline, such as weight, height, BMI and components of the metabolic syndrome and their association to the severity of obstructive sleep apnea will be studied in order to find predictors for the severity of the disease.

Official Title
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Effect of Bariatric Surgery on Obstructive Sleep Apnea and Predictors for the Severity of Obstructive Sleep Apnea

Conditions
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Obesity, Obstructive Sleep Apnea, Bariatric Surgery Candidate

Intervention / Treatment
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* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI above 30 kg/m2 Age between 20 and 70 years Willingness to understand the protocol and willingness to participate in the study Exclusion Criteria: Exclusion criteria is severe co-morbidities that would prevent the patients to undergo bariatric surgery. Such as severe anemia, severe heart failure, active or previous malignancies the last 5 years. Myocardial infarction or unstable angina pectoris the last 6 months. Pregnancy. Suspected poor compliance. Drug or alcohol abuse. Major gastrointestinal disease. Inability to undergo polysomnography.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in this study underwent either gastric bypass, gastric sleeve or biliopancreatic diversion. Some patient choose not to undergo bariatric surgery and function as a control arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biliopancreatic diversion<br>Study participants will undergo biliopancreatic diversion which is a type of bariatric surgery where a part of the stomach are removed and the remaining stomach is attached to a distal segment of the small intestine. | Procedure: Bariatric surgery<br>* Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.<br>|
| Active Comparator: Gastric sleeve<br>Study participants will undergo sleeve gastrectomy which is a restrictive form av bariatric surgery where the size of the stomach is reduced. | Procedure: Bariatric surgery<br>* Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.<br>|
| Active Comparator: Gastric bypass<br>Study participants will undergo gastric bypass which is a type of bariatric surgery where a small pouch of the stomach is created and attached to a segment of the small intestine. | Procedure: Bariatric surgery<br>* Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.<br>|
| No Intervention: No intervention<br>Study participants that do not want to undergo surgical treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of obstructive sleep apnea measured by a overnight cardio-respiratory monitoring before and 5 years after bariatric surgery. | The effect of bariatric surgery as a treatment of obstructive sleep apnea in patients with obesity will be evaluated as the change in obstructive sleep apnea severity. To address this aim a overnight cardio-respiratory monitoring with a Vital Night 8 device (Vital Aire, Milan, Italy) will be performed before and 5 years after bariatric surgery. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Obstructive sleep apnea, Bariatric surgery candidate, Metabolic syndrome