Sleep to Lower Elevated Blood Pressure

NCT ID: NCT01809821

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-06-30

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.

Conditions

Hypertension; Sleep Disorders; Insomnia; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Online Sleep Education

The sleep intervention is a multi-component online intervention consisting of sleep information and sleep hygiene education, along with behavioural and cognitive components.

Group Type: EXPERIMENTAL

Online Sleep Education

Intervention Type: BEHAVIORAL

Usual CV care

Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Online Sleep Education

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Research Board, Ireland

OTHER

Sponsor Role: collaborator

University College Hospital Galway

OTHER

Sponsor Role: lead

Responsible Party

Dr. Emer McGrath

Dr.Emer McGrath

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin J O'Donnell, MB PhD

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

HRB Clinical Research Facility Galway

Galway, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 25300874 (View on PubMed)

Other Identifiers

HRBCRFG-150213-EMG

Identifier Type: -

Identifier Source: org_study_id