NCT01809821CompletedNot Applicable
Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
University College Hospital Galway1 site in 1 country134 target enrollmentStarted: May 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Systolic Blood Pressure
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Systolic Blood Pressure
Time Frame: 8 weeks
To determine if the addition of a multi-component, online, sleep intervention to usual care (standard CV risk factor education), results in a greater reduction in mean 24-hr systolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period.
Secondary Outcomes
- Sleep efficiency(8 weeks)
- Sleep onset latency(8 weeks)
- ISI(8 weeks)
- SCI(8 weeks)
- Diastolic Outcome Measure(8 weeks)
- PSQI(8 weeks)
Investigators
Dr. Emer McGrath
Dr.Emer McGrath
University College Hospital Galway
Study Sites (1)
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