Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea
Condition: Lung Diseases; Sleep Apnea Syndromes; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Lung Diseases
Study type: Interventional

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.
    

Intervention name(s): Continuous Positive Airway Pressure (CPAP) Treatment; Sham CPAP device - CPAP device with pressure delivered <1 cm H20
Intervention type(s): Device; Device
Intervention description(s): CPAP device used at night; Sham CPAP device used at night
Other intervention name(s): Positive Airway Pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment