title: Diagnosis and Treatment of Sleep Apnea in patients' homes: the rationale and methods of the "GoToSleep" randomized-controlled trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: VA Health Services Research and Development (HSR&D) Stroke Quality Enhancement Research Initiative (QUERI), Indianapolis, IN 46202, USA.
authors.forename: Dawn M
authors.initials: DM
authors.lastname: Bravata
authors.forename: Jared
authors.initials: J
authors.lastname: Ferguson
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Miech
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
authors.forename: Vincent
authors.initials: V
authors.lastname: McClain
authors.forename: Charles
authors.initials: C
authors.lastname: Austin
authors.forename: Frederick
authors.initials: F
authors.lastname: Struve
authors.forename: Brian
authors.initials: B
authors.lastname: Foresman
authors.forename: Xinli
authors.initials: X
authors.lastname: Li
authors.forename: Zhu
authors.initials: Z
authors.lastname: Wang
authors.forename: Linda S
authors.initials: LS
authors.lastname: Williams
authors.forename: Mary I
authors.initials: MI
authors.lastname: Dallas
authors.forename: Cody D
authors.initials: CD
authors.lastname: Couch
authors.forename: Jason
authors.initials: J
authors.lastname: Sico
authors.forename: Carlos
authors.initials: C
authors.lastname: Fragoso
authors.forename: Marianne S
authors.initials: MS
authors.lastname: Matthias
authors.forename: Neale
authors.initials: N
authors.lastname: Chumbler
authors.forename: Jennifer
authors.initials: J
authors.lastname: Myers
authors.forename: Nicholas
authors.initials: N
authors.lastname: Burrus
authors.forename: Archana
authors.initials: A
authors.lastname: Dube
authors.forename: Dustin D
authors.initials: DD
authors.lastname: French
authors.forename: Arlene A
authors.initials: AA
authors.lastname: Schmid
authors.forename: John
authors.initials: J
authors.lastname: Concato
authors.forename: H Klar
authors.initials: HK
authors.lastname: Yaggi
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D001794:Blood Pressure; D045422:Continuous Positive Airway Pressure / Q000379:methods; D017048:Health Care Costs; D006297:Health Services Accessibility; D006699:Home Care Services / Q000458:organization & administration; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy; D002546:Ischemic Attack, Transient / Q000150:complications; D017286:Polysomnography / Q000379:methods; D012891:Sleep Apnea Syndromes / Q000150:complications / Q000175:diagnosis* / Q000191:economics / Q000628:therapy; D020521:Stroke / Q000150:complications; D014481:United States; D014493:United States Department of Veterans Affairs
chemical_list: D000959:Antihypertensive Agents