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. Author manuscript; available in PMC: 2015 Mar 1.
Published in final edited form as: West J Nurs Res. 2013 Aug 22;36(3):294–311. doi: 10.1177/0193945913500567

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