Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Condition: Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus; Diabetes Mellitus, Type 2; Sleepiness
Intervention: Continuous Positive Airway Pressure (CPAP); Sham- Continuous Positive Airway Pressure (Sham-CPAP)
Intervention description: Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).; Mask worn over nose to splint open the airway with positive pressure to prevent the subject from holding their breath (apneas).
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants on sham-CPAP were allowed to try actual CPAP.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The mask and equipment appeared similar to actual CPAP but does not give pressure required to prevent OSA. Only CPAP naive persons eligible.
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: daytime sleepiness; obstructive sleep apnea; type 2 diabetes mellitus; diabetes management

Summary:

      Daily physical activity is important to achieve glucose control in persons with type 2
      diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime
      symptom, excessive sleepiness, act as barriers to physical activity. We will examine if
      treatment of obstructive sleep apnea with continuous positive airway pressure results in
      increased physical activity in persons with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2DM (verified by primary care provider (PCP) or medication for T2DM)

          -  AHI (from PSG) greater than > 15

          -  A1c < 9.0%

          -  Epworth Sleepiness Sca;e > 10 (Baseline Assessment)

          -  Able to ambulate independently or with a cane

          -  Age 40-65 years

          -  BMI< 45

          -  No acute medical and psychiatric illness in past 3 months

          -  Self-reported sleep duration of at least 6 hours

          -  No changes in medications, including diabetic medications, in last 3 months

          -  Telephone access

          -  Able to perform study tests (e.g., speak, read and write in English)

          -  Willing to be randomized to CPAP or sham-CPAP

        Exclusion Criteria:

          -  Diagnosis of another sleep disorder, in addition to OSA,

          -  Oxygen or Bi-level positive airway pressure required for treatment of OSA

          -  An oxygen saturation <75% for >10% of the diagnostic PSG or if subject has oxygen
             saturation <75% for >25% of the first 4 h of the diagnostic PSG

          -  Any individual in the household currently or with history of CPAP treatment

          -  Type 1 or gestational diabetes

          -  Prescribed insulin for treatment of type 2 diabetes

          -  Regular use (> 3 times/week) of hypnotic or alerting medications

          -  History of a near-miss or automobile accident due to sleepiness

          -  Employed in transportation-related safety sensitive occupation such as an airline
             pilot, truck driver, or train engineer

          -  Currently working night or rotating shifts

          -  Routine consumption of alcohol as determined by >2 drinks day

          -  Known allergy to medical adhesives or dermatological conditions that would preclude
             wearing CGMS

          -  Swim or water aerobics >once a week

          -  Participation in contact sports or activity that may damage CGMS device or cause
             injury from monitor

          -  Claustrophobia that prevents wearing the CPAP mask

          -  Pregnancy