Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00801892
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT00801892
Study Brief:
Protocol Section:
NCT00801892