Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Completed · Phase 3 · Has a placebo group
Conditions studied: Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT00801892
- Run by
- Eileen R. Chasens
- People needed
- 23
- Starts
- 2009-04-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2017-11-08
Who can join
Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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