SLEPTSleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
Online Sleep Education
Mental Disorders+9
+ Nervous System Diseases
+ Neurologic Manifestations
Treatment Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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, stroke and cardiovascular disease (CVD). Hypertension is the most common and important risk factor for CVD, and even modest reductions in blood pressure result in significant reductions in stroke and myocardial infarction. In this randomised trial, the investigators aim to evaluate whether a simple, multi-component, online sleep intervention reduces blood pressure in patients with essential hypertension.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.134 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Signed written informed consent ≥18 years on entry to study Average automated Systolic Blood Pressure (SBP) monitor readings between 130 - 160 mmHg with average automated Diastolic Blood Pressure(DBP) monitor readings <110 mmHg on three occasions, measured in a valid standardized manner while seated, or average Ambulatory Blood Pressure Monitor (ABPM) SBP reading between 130-160 mmHg with average DBP reading <110 mmHg. Self-reported difficulty getting to sleep (defined as usually taking more than 30 mins to get to sleep), and/or staying asleep (usually waking up more than once per night) for at least 3 months duration Internet access and self-reported competency in using the internet Exclusion Criteria: Receiving > 2 antihypertensive medications, or recent change in antihypertensive medications (within previous 2 months) or planned change in antihypertensive medication in next 8 weeks Previous history of myocardial infarction, ischaemic stroke or transient ischaemic attack Previous history of congestive heart failure History of dialysis for chronic renal impairment or evidence of chronic kidney disease (eGFR <60 or albuminuria). Known history of diabetes mellitus Current ongoing sleep hygiene education or sleep related cognitive behavioural therapy Ongoing involvement in night shift work History of obstructive sleep apnoea (OSA) and previously received or currently receiving treatment for OSA (patients with a history of untreated OSA are eligible for inclusion). Known history of sleep disorders (i.e. narcolepsy; hypersomnias; parasomnias such as sleep walking, night terrors, recurring nightmares; periodic limb movements/restless leg syndrome; circadian rhythm sleep disorder) Unable to follow educational advice in the opinion of the clinician Baby or young children at home that wake during the night History of bipolar affective disorder History of psychosis History of major depression (defined as depression requiring hospitalization in the past or visit to psychiatry outpatient clinic in the past 3 months) Unstable depression (unstable will be defined as changes in antidepressant medications within the last 3 months - i.e. start, stop or change in dose.) Unstable anxiety disorders/panic attacks (unstable will be defined as changes in medications within the last 3 months - i.e. start, stop or change in dose.) Ongoing substance or alcohol abuse Planned surgery or hospitalization over the next 8 weeks (i.e. during the trial) Incapacitating pain or illness or other medical condition in which, in the opinion of the clinician, the sleep intervention is unlikely to be effective.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
HRB Clinical Research Facility Galway
Galway, IrelandOpen HRB Clinical Research Facility Galway in Google Maps