The Apnea Positive Pressure Long-term Efficacy Study (APPLES): Rationale, design, methods, and procedures

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Abstract

Study Objective: To assess the size, time course, and durability of the effects of long-term continuous positive airway pressure (CPAP) therapy on neurocognitive function, mood, sleepiness, and quality of life in patients with obstructive sleep apnea. Design: Randomized, double-blinded, 2-arm, sham-controlled, multicenter, long-term, intention-to-treat trial of CPAP therapy. Setting: Sleep clinics and laboratories at 5 university medical centers and community-based hospitals. Patients or Participants: Target enrollment is 1100 randomly assigned subjects across 5 clinical centers. Interventions: Active versus sham (subtherapeutic) CPAP. Measurements and Results: A battery of conventional and novel tests designed to evaluate neurocognitive function, mood, sleepiness, and quality of life. Conclusions: The Apnea Positive Pressure Long-term Efficacy Study (APPLES) is designed to study obstructive sleep apnea and test the effects of CPAP through a comprehensive, controlled, and long-term trial in a large sample of subjects with obstructive sleep apnea.

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Kushida, C. A., Nichols, D. A., Quan, S. F., Goodwin, J. L., White, D. P., Gottlieb, D. J., … Dement, W. C. (2006). The Apnea Positive Pressure Long-term Efficacy Study (APPLES): Rationale, design, methods, and procedures. Journal of Clinical Sleep Medicine, 2(3), 288–300. https://doi.org/10.5664/jcsm.26588

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