A planning study to address challenges in conducting future large-scale trials of sleep apnea treatment.
Sleep apnea patients with cardiovascular disease or risk factors.
2011-2014, subjects had two or three visits – baseline, 6-month, and/or 12-month follow-up.
National Heart, Lung, and Blood Institute and ResMed Foundation.
The Best Apnea Interventions for Research (BestAIR) study aimed to randomize approximately 180 patients with sleep apnea who had either established CVD or at least three CVD risk factors into a 12-mo, four-arm intervention study. All arms included nightly use of nasal dilator strips and conservative medical therapy (CMT) defined as education on healthy sleep and lifestyle. The two active arms were: (1) active CPAP delivered using standard support from a trained sleep technician; and (2) active CPAP enhanced by a behavioral promotion intervention delivered by a behavioral therapist. The two control arms were: (1) sham-CPAP; and (2) CMT alone. The primary physiological outcome was change in mean 24-h systolic blood pressure. Process measures were recruitment yields, retention rates, and CPAP adherence levels.
Read more about BestAIR at ClinicalTrials.gov (NCT01261390).
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This study was supported by NIH NHLBI [Grant 1U34HL105277] and a grant from ResMed Foundation. Equipment was donated by ResMed and Philips Respironics.