Completed

SLEPTSleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial

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What is being tested

Online Sleep Education

Behavioral
Who is being recruted

Mental Disorders+9

+ Nervous System Diseases

+ Neurologic Manifestations

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorUniversity College Hospital Galway
Last updated: September 3, 2014
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorUniversity College Hospital Galway
Last updated: September 3, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

134 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Mental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesSleep Disorders, IntrinsicDyssomniasCardiovascular DiseasesHypertensionSleep Initiation and Maintenance DisordersSleep Wake Disorders

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

No Intervention
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.

Study 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
CompletedOne Study Center