To determine whether functional status improves in patients with milder obstructive sleep apnea following continuous positive airway pressure (CPAP) treatment.

Condition	Treatment or Intervention
Lung Diseases Sleep Apnea Syndromes Sleep Hypertension	Device: Continuous positive airway pressure

Further Study Details: 

BACKGROUND: Obstructive sleep apnea (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. Continuous positive airway pressure (CPAP) is the primary treatment for sleep apnea. The column of pressure delivered to the upper airway by this device immediately eliminates the respiratory disturbances when it is applied. There is evidence from randomized controlled studies that CPAP also improves functional status, and the key manifestation of OSA, excessive daytime sleepiness, in individuals with severe OSI, i.e., RDI >30. However, there has been limited work exploring improvement in functional status in patients with less severe OSA, i.e., those with mild (RDI 5-15) or moderate (RDI 16-30) disease. The large placebo effect that has been reported in controlled studies of functional outcomes associated with OSA mandates the need for a placebo in investigations evaluating the true impact of this treatment. Results from the three randomized controlled studies in milder OSA that have examined this issue have been equivocal principally because of serious methodological limitations. It remains unclear whether CPAP treatment improves daily functioning in those with milder disease (RDI 5-30). This is a critical issue as this level of disease severity represents the largest segment of OSA and comprises 15% of the US population.

DESIGN NARRATIVE: Using Granger's model of functional assessment the study determines whether functional status improves in patients with milder OSA following CPAP treatment. The study employs a randomized placebo-controlled parallel groups design using a sham-CPAP device as the placebo in a large sample manifesting significant daytime sleepiness. The study tests the hypothesis that the change in functional status (measured by the Functional Outcomes of Sleep Questionnaire) after 8 weeks of treatment will be greater for patients treated with active CPAP compared to sham CPAP. Secondary aims of the study are: 1) to examine whether CPAP also improves daytime sleepiness; 2) to determine whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Genders Eligible for Study: Both Male and Female

Inclusion Criteria

Patients at screen will have the following

1. Newly diagnosed with OSA on overnight PSG with an RDI between 5 and 30 2. ESS score > 11 on two administrations of the instrument (Prescreening and Screening) each completed on a different day to avoid sporadic values and confirm the presence of excessive daytime sleepiness 3. Age >18 4. Stable medical history and no change in medications, including hypertension medications, in the last 3 months. 5. Stable psychiatric history and no change in psychotropic medications in the last 3 months. 6. No regular use (> 3 times/week) of sedative, hypnotic, or alerting medications (such as Modafinil) in the last 3 months. 7. The participant has telephone access.

Exclusion Criteria

Patients entering the study at screen will not have the following:

1. Unable or unwilling to provide informed consent 2. Diagnosis of another sleep disorder in addition to OSA based on PSG, e.g., Periodic Limb Movement Disorder (>10 limb movements/hour of sleep with arousal); central sleep apnea (> 5 or more central apneas26); insomnia, sleep hypoventilation syndrome, or narcolepsy) 3. Previous treatment for sleep apnea with nasal CPAP, oral appliance, home oxygen therapy, uvulopalatopharyngoplasty, tracheotomy, or other surgery for OSA 4. Oxygen or Bi-level CPAP required for treatment of OSA 5. Unable to return for instructions or follow-up testing 6. Medically unstable condition (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, or uncontrolled thyroid disease, unstable diabetes, depression or psychosis, ventricular arrhythmias, cirrhosis, or recently diagnosed cancer) in the last three months 7. Chronic nasal congestion over the last three months that would prevent the use of the nasal mask 8. History of an automobile accident due to excessive daytime sleepiness 9. Employed in transportation-related safety sensitive occupation such as an airline pilot, truck driver, or train engineer 10. Night shift worker in situation or occupation where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months. 11. Regular use of alcohol as determined by answering yes to one or more of the questions on the CAGE questionnaire (alcohol dependent) 12. Recent or recurring history of substance abuse leading to tolerance or dependence 13. Pregnant. Women will either be postmenopausal or confirmed not pregnant by a pregnancy test using a normal voiding urine sample 14. Unable to perform 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) 15. Residing with an individual who is currently using CPAP treatment.

New York
      North Shore-Long Island Jewish Health System (LIJ), Long Island,  New York,  United States; Recruiting
      New York University Medical School, New York,  New York,  United States; Recruiting
Canada, Ontario
      University of Western Ontario (UWO), London,  Ontario,  Canada; Recruiting

Study chairs or principal investigators

Terri Weaver,  University of Pennsylvania   

Study ID Numbers:  163
Record last reviewed:  March 2005
Last Updated:  March 17, 2005
Record first received:  August 12, 2004
ClinicalTrials.gov Identifier:  NCT00089752
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08