title: Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Sleep is an essential component of good physical and mental health. Previous studies have reported that poor quality sleep is associated with an increased risk of hypertension and cardiovascular disease. Hypertension is the most common and important risk factor for cardiovascular disease, and even modest reductions in blood pressure can result in significant reductions in the risk of stroke and myocardial infarction. In this trial, we will determine the efficacy of an online sleep intervention in improving blood pressure, in participants with hypertension and poor sleep quality.
  
  
  METHODS
  
  
  
  METHODS
  Randomized-controlled, two-group, parallel, blinded, single-center, Phase II trial of 134 participants. Population and recruitment: Primary prevention population of participants with hypertension (systolic blood pressure, 130 to 160 mm Hg; diastolic blood pressure, <110 mm Hg) and poor sleep quality in a community setting.
  
  
  METHODS
  Multicomponent online sleep intervention consisting of sleep information, sleep hygiene education, and cognitive behavioral therapy. Comparator: Standardized cardiovascular risk factor and lifestyle-education session (usual care).
  
  
  METHODS
  Change in mean 24-hour ambulatory systolic blood pressure between baseline and 8-week follow-up. Hypertension has been selected as the primary outcome measure because of its robust association with both poor sleep quality and cardiovascular disease.
  
  
  METHODS
  Intention-to-treat analysis by using a linear mixed model.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01809821, registered March 8, 2013.
authors.affiliation: HRB Clinical Research Facility, National University of Ireland, Galway, Ireland. emcgrath2@partners.org.
authors.forename: Emer R
authors.initials: ER
authors.lastname: McGrath
authors.forename: Colin A
authors.initials: CA
authors.lastname: Espie
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Murphy
authors.forename: John
authors.initials: J
authors.lastname: Newell
authors.forename: Alice
authors.initials: A
authors.lastname: Power
authors.forename: Sarah
authors.initials: S
authors.lastname: Madden
authors.forename: Molly
authors.initials: M
authors.lastname: Byrne
authors.forename: Martin J
authors.initials: MJ
authors.lastname: O'Donnell
mesh_terms: D001794:Blood Pressure; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D057194:Intention to Treat Analysis; D020407:Internet; D007494:Ireland; D016014:Linear Models; D010353:Patient Education as Topic; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012890:Sleep; D012893:Sleep Wake Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome