Diagnosis and Treatment of Sleep Apnea in Patients' Homes: The Rationale and Methods of the “GoToSleep” Randomized-Controlled Trial
1VA Health Services Research and Development (HSR&D) Stroke Quality Enhancement Research Initiative (QUERI), Indianapolis, IN; 2VA HSR&D Center of Excellence on Implementing Evidence-Based Practice (CIEBP); Richard L. Roudebush VA Medical Center, Indianapolis, IN; 3Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN; 4Department of Neurology, Indiana University School of Medicine; 5Regenstrief Institute, Indianapolis, IN; 6Clinical Epidemiology Research Center, VA Connecticut Healthcare System, West Haven, CT; 7VA Connecticut Healthcare System, West Haven, CT; 8Department of Internal Medicine, Yale University School of Medicine, New Haven, CT; 9Department of Neurology, Yale University School of Medicine, New Haven, CT; 10Department of Biostatistics, Yale University, New Haven, CT; 11Sleep Medicine Service, Richard L. Roudebush VA Medical Center, Indianapolis, IN; 12Internal Medicine Service, Richard L. Roudebush VA Medical Center, Indianapolis, IN; 13Indiana University School of Liberal Arts, Indianapolis, IN; 14Indiana University School of Health and Rehabilitation Science, Indianapolis, IN; 15Department of Communication Studies, Indiana University-Purdue University at Indianapolis (IUPUI), Indianapolis, IN
The “Diagnosis and Treatment of Sleep Apnea in Cerebrovascular Disease” (GoToSleep) study is evaluating a strategy to improve the diagnosis and treatment of sleep apnea among veterans with stroke or transient ischemic attack (TIA) who also have hypertension. Specifically, the GoToSleep study was designed to overcome some of the barriers that exist within the Veterans Health Administration (VHA) to the timely diagnosis and treatment of sleep apnea by using ambulatory home-based polysomnography and auto-titrating continuous positive airway pressure (CPAP) to reduce the reliance on laboratory-based sleep studies.
The GoToSleep study is a prospective, multi-site, randomized, controlled strategy trial among an expected 318 veterans with cerebrovascular disease and hypertension who are assigned to an intervention group or a control group. Patients in the intervention group receive unattended polysomnography at baseline, and those with sleep apnea receive auto-titrating CPAP therapy for up to one year. Patients in the control group receive usual care and unattended polysomnography at the end of the study to identify the rate of undiagnosed sleep apnea. The primary objectives of the GoToSleep study are to determine whether a diagnostic and therapeutic intervention strategy among veterans with cerebrovascular disease and hypertension improves: (1) detection of sleep apnea; (2) appropriate treatment for sleep apnea; and (3) control of hypertension. Twenty-four-hour blood pressure assessments are made at baseline and at the end of the one-year study period for both groups. Antihypertensive medications and their doses are recorded at the time of the 24-hour blood pressure measurements.
This manuscript provides the rationale for 4 key components of the design of the GoToSleep trial: the inclusion of patients with cerebrovascular disease and hypertension without the use of a measure of daytime sleepiness as an eligibility criterion; the use of portable polysomnography and auto-titrating CPAP in patients' homes rather than using sleep laboratory polysomnography with fixed pressure CPAP; the analytic approach to evaluating change in blood pressure in the context of change in antihypertensive medications; and the use of a usual care control group.
Bravata DM; Ferguson J; Miech EJ; Agarwal R; McClain V; Austin C; Struve F; Foresman B; Li X; Wang Z; Williams LS; Dallas MI; Couch CD; Sico J; Fragoso C; Matthias MS; Chumbler N; Myers J; Burrus N; Dube A; French DD; Schmid AA; Concato J; Yaggi HK. Diagnosis and treatment of sleep apnea in patients' homes: the rationale and methods of the “GoToSleep” randomized-controlled trial. J Clin Sleep Med 2012;8(1):27–35.
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