Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea

Completed · Not applicable · Has a placebo group

Conditions studied: Lung Diseases, Sleep Apnea Syndromes, Hypertension

In brief

The purpose of this study is to determine whether functional status improves in individuals with milder obstructive sleep apnea (OSA) following continuous positive airway pressure (CPAP) treatment.

Key facts

Study ID

NCT00089752

Run by

University of Pennsylvania

People needed

281

Starts

2003-09-01

Expected to finish

2008-11-01

Last updated by the study team

2017-07-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed with OSA on overnight polysomnogram (PSG) with RDI between 5 and 30
• Score of greater than 11 on the Epworth Sleepiness Scale (ESS) on two administrations of the instrument (performed at prescreening and screening), each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness
• Stable medical history and no change in medications, including hypertension medications, in the 3 months prior to study entry
• Stable psychiatric history and no change in psychotropic medications in the 3 months prior to study entry
• Has access to a telephone

You may not qualify if…

• Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., periodic limb movement disorder (greater than 10 limb movements per hour of sleep with arousal); central sleep apnea (greater than 5 or more central apneas); insomnia; sleep hypoventilation syndrome; or narcolepsy
• Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA
• Oxygen or bi-level CPAP required for treatment of OSA
• Unable to return for study instructions or follow-up testing
• Medically unstable condition (e.g., heart attack, congestive heart failure, Cheyne-Stokes breathing, unstable angina, uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the 3 months prior to study entry
• Regular use (greater than 3 times per week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the 3 months prior to study entry
• Chronic nasal congestion that would prevent the use of a nasal mask, in the 3 months prior to study entry
• History of automobile accidents due to excessive daytime sleepiness
• Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer
• Night shift worker regularly experiencing jet lag, or a history of irregular work schedules in the 6 months prior to study entry
• Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (i.e., alcohol dependent)
• Recent or recurring history of substance abuse leading to tolerance or dependence
• Pregnant; women must either be postmenopausal or confirmed not pregnant by a urine pregnancy test
• Unable to perform study tests, e.g., inability to communicate verbally; inability to write and read in English; less than a 5th grade reading level (evaluated using Flesch-Kincaid assessment); visual impairment; hearing impairment; cognitive impairment (e.g., previous head injury); or upper extremity motor deficit (e.g., previous stroke or spinal cord injury)
• Residing with an individual who is currently using CPAP treatment

Where it is running

• National Jewish Medical and Research Center (NJC) — Denver, Colorado, United States
• Emory University School of Medicine (EMO) — Atlanta, Georgia, United States
• North Shore-Long Island Jewish Health System (LIJ) — Long Island City, New York, United States
• New York University Medical School — New York, New York, United States
• University of Western Ontario (UWO) — London, Ontario, Canada

Full record on ClinicalTrials.gov

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