Cost Effectiveness of Ambulatory Management for Veterans With Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This research study is comparing home and in-laboratory testing of veterans with suspected
      obstructive sleep apnea, a common breathing disorder during sleep. It is hoped that home
      testing will be equally effective in improving quality of life but have lower cost than
      in-lab testing. These findings will allow veterans to have greater access to diagnosis and
      treatment of their sleep apnea.
    

Detailed description: 
      Objective: The overall goal of the project is to improve access to care for veterans with
      suspected obstructive sleep apnea (OSA), a breathing disorder during sleep characterized by
      repetitive closure of the pharyngeal airway. Portable monitors are commercially available to
      diagnose participants with suspected OSA and establish the continuous positive airway
      pressure (CPAP) setting needed for treatment. Their application to home testing is not widely
      accepted because it is not known whether home testing, when compared to conventional in-lab
      polysomnograms, is cost effective and produces similar outcomes with regard to participant
      adherence to CPAP treatment and improvements in functional impairment. The specific goals of
      the proposed research are to address these barriers by comparing the functional impact, cost,
      and cost-effectiveness of evaluating veterans with suspected OSA using home versus in-lab
      testing.

      Research Design: In this prospective randomized control trial of equivalency, participants
      referred to the Philadelphia and Pittsburgh VA Medical Centers for evaluation for OSA will be
      randomized to either exclusively in-lab or home testing following baseline assessment.

      Methodology: In-lab polysomnograms will be performed to diagnose OSA and titrate the pressure
      setting for subsequent CPAP therapy. Self-administered home testing will consist of an
      overnight unattended sleep study followed by a 1-week autoCPAP titration trial. Objectively
      assessed CPAP adherence and its consequent effects on subjective and objective daytime
      sleepiness, disease specific and general functional impairment, and participant preference
      will be obtained at 1- and 3-months after starting CPAP treatment and 3-monthly thereafter to
      the end of study follow-up. Medical service use and cost will be collected for the entire
      observation period.

      Aim 1 will determine if participants with suspected OSA who receive home testing have the
      same adherence to subsequent CPAP treatment and the same functional outcomes as participants
      receiving in-lab testing. Primary outcome measures will be 1) objectively measured adherence
      to CPAP treatment and 2) the global score on the Functional Outcomes of Sleep Questionnaire
      (FOSQ) to assess the consequent effects of adherence on disease specific functional
      impairment. Secondary functional outcome measures will assess subjective (Epworth Sleepiness
      Scale) and objective (Psychomotor Vigilance Test) daytime sleepiness, and general quality of
      life (SF-12). Hypothesis 1: Despite differences between in-lab versus home testing in terms
      of technology, time participants interact with health care professionals, and environment,
      there is no clinically significant decline in mean CPAP adherence and no clinically
      significant reduction in functional outcomes in participants receiving home versus in-lab
      testing.

      Aim 2 will compare the differences in cost and quality-adjusted life years saved (QALYS)
      between home versus in-lab testing to estimate a cost-effectiveness ratio. Participant
      preference will be assessed with the EuroQol (EQ-5D) and Health Utilities Index 2 (HUI).
      Hypothesis 2a: Average total health-care delivery cost is lower for veterans receiving home
      testing relative to those receiving in-lab testing. Hypothesis 2b: Because we believe that
      at-home testing will have lower costs and equivalent outcomes, we will be 90% confident that
      the cost per QALY ratio comparing at-home testing with in-lab testing will be less than
      $100,000.

      Clinical Relationship: We need to determine the most cost effective way to diagnose veterans
      with OSA and initiate them on CPAP treatment. If the results show that home testing produces
      clinical outcomes that are not significantly clinically inferior and similar or reduced costs
      compared with in-lab testing, decision makers can be confident that home monitors can be used
      to diagnose and treat OSA and that improving veterans' access to care for OSA need not
      require construction of additional, costly sleep labs.

      Findings: We anticipate that the results of Aim 1 will demonstrate that participants
      receiving in-lab versus home testing have similar clinical outcomes. We further anticipate
      that Aim 2 will demonstrate that home testing is more cost effective than in-lab testing. If
      confirmed, these findings will lead to wide acceptance of home portable monitor testing and
      increase veteran access to care.
    

Intervention name(s): Continuous positive airway pressure apparatus
Intervention type(s): Device
Intervention description(s): Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure.
Other intervention name(s): CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Polysomnogram; Continuous positive airway pressure