Status:
COMPLETED
Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Respironics Sleep and Respiratory Foundation
Conditions:
Lung Diseases
Sleep Apnea Syndromes
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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.
Detailed Description
BACKGROUND: OSA is characterized as mild, moderate, or severe, according to the number of respiratory disturbances per hour of sleep (RDI), as defined by the American Academy of Sleep Medicine. CPAP ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00089752
Start Date
September 1 2003
End Date
November 1 2008
Last Update
July 24 2017
Active Locations (5)
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1
National Jewish Medical and Research Center (NJC)
Denver, Colorado, United States, 80206
2
Emory University School of Medicine (EMO)
Atlanta, Georgia, United States, 30329
3
North Shore-Long Island Jewish Health System (LIJ)
Long Island City, New York, United States, 11040
4
New York University Medical School
New York, New York, United States, 10016