Rapid Eye Movement Related OSA in Diabetic Versus Non-Diabetic Patients Treated With PCI
Condition: Obstructive Sleep Apnea; Diabetes Mellitus; Coronary Artery Disease
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Coronary Artery Disease
Study type: Observational

Summary: 
      The primary objective of the Sleep and Stent II is to determine the prevalence of REM-OSA in
      DM versus non-DM patients undergoing clinically indicated PCI.

      The secondary objectives are to investigate the association between REM-AHI and (1) cardiac
      arrhythmia based on ambulatory ECG monitoring, (2) excessive daytime sleepiness, and (3)
      glycemic control in patients with DM.

      In addition, we will determine the prevalence of REM-OSA based on alternative definitions,
      including (a) overall AHI at least 5 with AHI REM/AHI NREM ratio at least 2; (b) overall AHI
      at least 5 with AHI REM/AHI NREM ratio at least 2 and with AHI NREM < 15; (c) overall AHI at
      least 5, AHI REM/AHI NREM ratio at least 2 and with AHI NREM < 8.
    

Detailed description: 
      The Sleep and Stent II is a cross-sectional study of patients who have undergone PCI for
      coronary artery disease. A total of 200 adult patients who have undergone clinically
      indicated PCI between 6 and 36 months ago are eligible. The study involves the 2 national
      heart centers and the Ng Teng Fong General Hospital in Singapore (3 centers in total). The
      National University Heart Center Singapore is the leading center and it is responsible for
      the overall study design and study conduct. The estimated duration of the Sleep and Stent II
      is 3 years (2018-2020).

      All subjects and/or their legally authorized representative must provide written informed
      consent before any study-related procedure can be conducted. The patients will be divided
      into DM and non-DM groups, and the two groups will be matched for age, sex, and BMI. As a
      standard clinical practice in Singapore, patients who have undergone PCI will be followed up
      at the outpatient clinic for continuation of care. As such, the recruitment will be conducted
      at the outpatient clinic. All recruited patients will undergo an overnight polysomnography at
      the National University Health System Cardiosleep research laboratory.

      All polysomnography studies will be conducted using a standardized level I diagnostic device
      (Embla RemLogic, Natus Medical Inc. Canada). Outputs recorded from the portable diagnostic
      device will be manually scored by an independent sleep technologist with Registered
      Polysomnographic Technologist credentials, blinded to the patients' clinical characteristics.

      The primary measure of the polysomnography will be the AHI, quantified as the total number of
      apneas and hypopneas per hour of sleep. An apnea is defined as a 90% or greater decrease in
      airflow from the baseline value for at least 10 seconds. Apneas are further classified as
      obstructive or central based on the presence or absence, respectively, of respiratory-related
      chest wall movement. Hypopnea is defined as a 30-90% reduction in airflow from the baseline
      value lasting 10 seconds or more, in conjunction with ≥3% oxygen desaturation. The
      respiratory event scoring will be performed according to the American Academy of Sleep
      Medicine guidelines. For all patients the AHI during total sleep time, the AHI during REM
      (AHI-REM), and the AHI during non-REM sleep (AHI-NREM) will be calculated. REM OSA is defined
      in a variety of ways including AHI at least 5 withAHI-REM/AHI-NREM ratio at least 2; overall
      AHI at least 5 with AHI-REM/ AHI-NREM ratio at least 2 and with AHI-NREM less than 15;
      overall AHI at least 5, AHI-REM/AHI-NREM ratio at least 2 and with AHI-NREM less than 8.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have undergone clinically indicated PCI between 6 and 36 months ago
      
Keywords: sleep apnea, coronary artery, diabetes