Status:
COMPLETED
Obstructive Sleep Apnea (OSA), Sleepiness, and Activity in Diabetes Management
Lead Sponsor:
Eileen R. Chasens
Conditions:
Sleep Apnea, Obstructive
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40-65 years
Phase:
PHASE3
Brief 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 s...
Detailed Description
Obstructive sleep apnea (OSA) is a serious disorder characterized by episodic obstruction of the pharyngeal airway accompanied by cessation or reduction in airflow. Untreated OSA has a negative impact...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00801892
Start Date
April 1 2009
End Date
April 1 2012
Last Update
November 8 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261