Obstructive Sleep Apnea, Predictors and Bariatric Surgery
Condition: Obesity; Obstructive Sleep Apnea; Bariatric Surgery Candidate
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Obesity; Obstructive sleep apnea; Bariatric surgery candidate; Metabolic syndrome