Clinical trial NCT01809821: Sleep to Lower Elevated Blood Pressure
Official title: Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Sleep Disorders
Insomnia
Cardiovascular Diseases
Keywords: Hypertension
Sleep Disorders
Insomnia
Cardiovascular Diseases
Internet treatment
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
Collaborators: name: Health Research Board, Ireland
First posted: 2013-03-13
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Diastolic Outcome Measure
timeFrame: 8 weeks
measure: Sleep efficiency
timeFrame: 8 weeks
measure: Sleep onset latency
timeFrame: 8 weeks
measure: PSQI
timeFrame: 8 weeks
measure: SCI
timeFrame: 8 weeks
measure: ISI
timeFrame: 8 weeks
Other outcomes:
measure: Body Mass Index
timeFrame: 8 weeks
measure: Plasma lipoproteins
timeFrame: 8 weeks
measure: Plasma HbA1c
timeFrame: 8 weeks
measure: eGFR
timeFrame: 8 weeks
measure: Insomnia Severity Index
timeFrame: 8 weeks
measure: Sleep Condition Indicator Score
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
measure: Mean number of cigarettes smoked
timeFrame: 8 weeks
measure: Sleep onset latency
timeFrame: 8 weeks
measure: Wake time to sleep onset
timeFrame: 8 weeks
measure: Sleep efficiency
timeFrame: 8 weeks
measure: Beck Depression Inventory score
timeFrame: 8 weeks
measure: Beck Anxiety Inventory score
timeFrame: 8 weeks
measure: Smoking status
timeFrame: 8 weeks
measure: Diastolic blood pressure
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
measure: Total Sleep Time
timeFrame: 8 weeks
measure: Diastolic blood pressure
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
Locations:
city: Galway
country: Ireland
facility: HRB Clinical Research Facility Galway
Study officials:
affiliation: National University of Ireland, Galway
name: Martin J O'Donnell, MB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGrath ER, Espie CA, Murphy AW, Newell J, Power A, Madden S, Byrne M, O'Donnell MJ. Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial. Trials. 2014 Oct 9;15:393. doi: 10.1186/1745-6215-15-393.