Sleep to Lower Elevated Blood Pressure

NCT01809821 | Completed

• 1 other identifier: HRBCRFG-150213-EMG
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension; Sleep Disorders; Insomnia; Cardiovascular Diseases; Internet treatment

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  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.

  8 weeks

Secondary Outcomes (6)

• Diastolic Outcome Measure

  8 weeks

• Sleep efficiency

  8 weeks

• Sleep onset latency

  8 weeks

• PSQI

  8 weeks

• SCI

  8 weeks

Other Outcomes (21)

• Body Mass Index

  8 weeks

• Plasma lipoproteins

  8 weeks

• Plasma HbA1c

  8 weeks

Study Arms (2)

Online Sleep Education

EXPERIMENTAL

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

Behavioral: Online Sleep Education

Usual CV care

NO INTERVENTION

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

Interventions

Online Sleep Education BEHAVIORAL

Online Sleep Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• University College Hospital Galway: lead
• Health Research Board, Ireland: collaborator

Study Sites (1)

HRB Clinical Research Facility Galway

Galway, Ireland

Location

Related Publications (1)

• 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.

  PMID: 25300874 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Martin J O'Donnell, MB PhD

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Emer McGrath

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 13, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

IE (1)