Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea (CATNAP)
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|ClinicalTrials.gov Identifier: NCT00089752|
Recruitment Status : Completed
First Posted : August 16, 2004
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
|Condition or disease||Intervention/treatment|
|Lung Diseases Sleep Apnea Syndromes Hypertension||Device: Continuous Positive Airway Pressure (CPAP) Treatment Device: Sham CPAP device - CPAP device with pressure delivered <1 cm H20|
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 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, including excessive daytime sleepiness, in individuals with severe OSI (i.e., RDI greater than 30). However, there has been limited research exploring improvement in functional status in individuals with less severe OSA (i.e., those with mild OSA and RDI of 5-15 or moderate OSA and RDI of 16-30). The large placebo effect that has been reported in controlled studies of OSA-associated functional outcomes mandates the need for a placebo in studies 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 OSA (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 U.S. population.
Using Granger's model of functional assessment, this study will examine whether functional status improves in participants with milder OSA following CPAP treatment. The study will employ a randomized, placebo-controlled, parallel study design, and will use a sham CPAP device as the placebo in participants with significant daytime sleepiness. The study will test 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 participants treated with active CPAP compared to the placebo. Secondary aims of the study include examining whether CPAP also improves daytime sleepiness, and determining whether CPAP can reduce nocturnal blood pressure to lower the risk for stroke and hypertension linked to OSA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||281 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)|
|Study Start Date :||September 2003|
|Primary Completion Date :||August 2008|
|Study Completion Date :||November 2008|
Active Comparator: Active Treatment
Continuous Positive Airway Pressure Treatment
Device: Continuous Positive Airway Pressure (CPAP) Treatment
CPAP device used at night
Other Name: Positive Airway Pressure
Placebo Comparator: Sham/Placebo Treatment
Ineffective sham continuous positive airway pressure device with leak in interface to <1.0 cm H2O and resistance in motor to simulate normal operating noise and no compensation for leak.
Device: Sham CPAP device - CPAP device with pressure delivered <1 cm H20
Sham CPAP device used at night
- Change in the Score of the Functional Outcomes of Sleep Questionnaire at Baseline and Week 8 Treatment [ Time Frame: 8 weeks ]The primary endpoint is change after 8 weeks of treatment from baseline value (controlling for baseline value) in the 30-item Functional Outcomes of Sleep Questionnaire (FOSQ) that will be used to test the primary study hypothesis that patients with milder OSA (RDI 5-30) on active treatment will demonstrate greater mean change for the Total score from baseline to 8 weeks treatment. The FOSQ is designed to assess the impact of excessive sleepiness on functional status. The instrument has established content validity, test-retest reliability (r= 0.91), and internal consistency (alpha = 0.96). The scale ranges from 5 - 20 with normal functional status being a value greater than 17.
- Change in the Score From Baseline to 8 Weeks Treatment Epworth Sleepiness Scale [ Time Frame: Measured at Baseline and Week 8 of treatment in ITT sample ]Change in the score from baseline to 8 weeks treatment, controlling for baseline in the self-rated 8 item measure of daytime sleepiness with a range from 0 - 24. Lower values indicting less daytime sleepiness
- Change in Mean Arterial Daytime Pressure at Baseline and Week 8 Treatment [ Time Frame: Measured at Baseline and Week 8 treatment in the ITT sample ]Change in mean arterial pressure (MAP) value from baseline to 8 weeks treatment, controlling for baseline, measured by 48 hours ambulatory blood pressure device - Space Laboratories
- Change in the Score From Baseline to 8 Weeks Treatment Measured by the Profile of Mood States [ Time Frame: Measured at Baseline and Week 8 treatment in the ITT sample ]Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the POMS is a reliable and valid measure of mood states that consists of 65 adjectives on which subjects' rate themselves as they feel "today" using a five-point scale. There are six mood or affective states on this test derived through factor analysis: Tension-Anxiety (score range 0-36), Depression-Dejection (score range 0 - 60), Anger-Hostility (score range 0-48), Vigor-Activity (score range 0-32), Fatigue-Inertia (score range 0-28), and Confusion-Bewilderment (score range 0-28). There is also a summary Total Mood Disturbance (TMD) score that gives a Total estimate of affective state score range 0-200). Higher scores indicate greater disability.
- Change in the Number of Lapses From Baseline to 8 Weeks Treatment on the Psychomotor Vigilance Task (PVT) - Total Lapses in 20 Minute Test [ Time Frame: Baseline and 8 weeks of treatment in the ITT sample ]Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the PVT is an objective assessment of sleepiness and measures decrements in neurobehavioral performance due to sleepiness, i.e., ability to sustain attention and respond in a timely manner to salient signals.(7) The PVT yields five highly informative metrics on the capacity for sustained attention and vigilance performance: frequency of lapses, duration of lapse domain, optimum response time, vigilance decrement function, false response frequency. We applied this conceptually valid, relatively short duration, reliable task with known psychometric properties and minimal practice/learning curves to document attentional lapses (response times > 500 msec) in performance.
- Change in the Score From Baseline to 8 Weeks Treatment on the SF36 - Physical [ Time Frame: Baseline and Week 8 of treatment in ITT sample. ]Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
- Change in the Score From Baseline to 8 Weeks Treatment SF-36 Mental Component [ Time Frame: Baseline and after 8 weeks of treatment in ITT sample ]Change in the score from baseline to 8 weeks treatment, controlling for baseline, in the SF-36 is a 36-item questionnaire that assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate greater disability with a range of scores from 0-100.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089752
|United States, Colorado|
|National Jewish Medical and Research Center (NJC)|
|Denver, Colorado, United States, 80206|
|United States, Georgia|
|Emory University School of Medicine (EMO)|
|Atlanta, Georgia, United States, 30329|
|United States, New York|
|North Shore-Long Island Jewish Health System (LIJ)|
|Long Island City, New York, United States, 11040|
|New York University Medical School|
|New York, New York, United States, 10016|
|University of Western Ontario (UWO)|
|London, Ontario, Canada|
|Study Chair:||Terri Weaver||University of Pennsylvania|