Apnea Positive Pressure Long-Term Efficacy Study
Condition: Lung Diseases; Sleep Apnea Syndromes; Sleep
MeSH terms: Apnea; Sleep Apnea Syndromes; Lung Diseases
Intervention: Active CPAP; Sham CPAP
Intervention description: Nightly nasal continuous positive airway pressure (CPAP); Sham CPAP machine will be used for participants in the placebo group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea

Summary:

      The purpose of this study is to determine the effectiveness of nasal continuous positive
      airway pressure (CPAP) therapy for the treatment of obstructive sleep apnea syndrome (OSAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults age 18 years or older with a diagnosis of OSAS using clinical
             criteria defined by the study protocol

          -  Study participation may require seven or more laboratory visits over six months

        Exclusion Criteria:

          -  Prior treatment for OSAS with continuous positive airway pressure or surgery

          -  Potential sleep apnea complications that may affect the health or safety of the
             participant, including low blood oxygen, recent near-miss or prior automobile accident
             due to sleepiness, congestive heart failure, history of angina, coronary artery
             disease, myocardial infarction or stroke, cardiac rhythm disturbance, and chronic
             neurological disorders affecting neurocognitive abilities or daily function

          -  The use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating
             antihistamines, stimulants or other medications likely to affect neurocognitive
             function and/or alertness

          -  Respiratory disease requiring medications (unless on stable medications for 2 months)

          -  Cancer, unless in remission for greater than one year and not taking exclusionary
             medications

          -  Self-reported renal failure

          -  Pregnancy anytime during a subject's participation

          -  Psychiatric illness, as defined by a DSM-IV diagnosis, except for depression or mild
             anxiety

          -  Narcolepsy, idiopathic hypersomnolence, DSM-IV chronic insomnia, restless legs
             syndrome, or rapid eye movement (REM) behavior disorder

          -  Current use of diurnal or nocturnal supplemental oxygen

          -  Significant vision, hearing, or coordination problems

          -  Difficulty understanding or speaking English

          -  Currently working night or rotating shifts

          -  Consumption of more than 10 caffeinated beverages per day (approximately 1,000 mg per
             day)

          -  Smokers whose habit interferes with the overnight polysomnogram or with the battery of
             testing during the day

          -  Consumption of more than 2 alcoholic beverages per day

          -  Any illicit drug usage or marijuana usage more than once a week

          -  Any individual in the household currently on CPAP or on CPAP in the past

          -  A score of 26 or less on the Mini Mental State Examination (MMSE)