Apnea Positive Pressure Long-Term Efficacy Study

Completed · Phase 3 · Has a placebo group

Conditions studied: Lung Diseases, Sleep Apnea Syndromes, Sleep

In brief

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).

Key facts

Study ID

NCT00051363

Run by

Stanford University

People needed

1105

Starts

2002-09-01

Expected to finish

2008-09-01

Last updated by the study team

2018-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Arizona AHSC — Tucson, Arizona, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• St. Luke's Hospital — Chesterfield, Missouri, United States
• St. Mary Medical Center — Walla Walla, Washington, United States

Full record on ClinicalTrials.gov

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