NCT00089752

Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea

Impact of CPAP on Functional Outcomes in Milder Obstructive Sleep Apnea (CATNAP)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 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. DESIGN NARRATIVE: 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.

Conditions

• Lung Diseases
• Sleep Apnea Syndromes
• Hypertension

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure (CPAP) Treatment	CPAP device used at night
DEVICE	Sham CPAP device - CPAP device with pressure delivered <1 cm H20	Sham CPAP device used at night

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-08-01
• Completion: 2008-11-01
• First posted: 2004-08-16
• Last updated: 2017-07-24
• Results posted: 2017-07-24

Locations

5 sites across 2 countries: United States, Canada