Table 1.
Study Inclusion and Exclusion Criteria
| Inclusion criteria | Exclusion criteria |
|---|---|
|
| |
| • T2DM (verified by primary care provider or medication typically ordered for diabetes) | • Diagnosis of another sleep disorder, in addition to OSA, based on PSG (e.g., periodic limb movement disorder ≥ 10 limb movements/hr, or insomnia) |
| • AHI (from PSG) greater than ≥ 10 | • Oxygen or Bi-level positive airway pressure required for treatment of OSA |
| • A1C< 9.0% | • 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 |
| • ESS ≥ 10 (Screening) | • Any individual in the household currently or with history of CPAP treatment |
| • Able to ambulate independently or with a cane | • Type 1 or gestational diabetes |
| • Age 30 years or older | • Prescribed insulin for treatment of T2DM |
| • No acute medical and psychiatric illness in past 3 months | • Changes in diabetic medications in prior 3 months |
| • Self-reported sleep duration of at least 6 hours by baseline Sleep/Activity Diary | • Regular use (> 3 times/week) of hypnotic or alerting medications (i.e. modafinil) |
| • Telephone access | • Prior treatment for OSA with CPAP or surgery |
| • Able to perform study tests (e.g., speak, read and write in English). | • History of a near-miss or automobile accident due to sleepiness |
| • Willing to be randomized to CPAP or sham-CPAP | • Employed in transportation-related safety sensitive (i.e. airline pilot, truck driver, or train engineer) |
| • Currently working night or rotating shifts | |
| • Routine consumption of alcohol as determined by >2 drinks day | |
| • Claustrophobia that prevents wearing the CPAP mask | |
| • Pregnancy | |
T2DM= type 2 diabetes mellitus; AHI= apnea + hypopnea index; ESS= Epworth Sleepiness Scale; CPAP= continuous positive airway pressure, OSA= obstructive sleep apnea; PSG= polysomnography