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Sleep to Lower Elevated Blood Pressure (SLEPT)

Primary Purpose

Hypertension, Sleep Disorders, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Online Sleep Education
Sponsored by
University College Hospital Galway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Sleep Disorders, Insomnia, Cardiovascular Diseases, Internet treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • HRB Clinical Research Facility Galway

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online Sleep Education

Usual CV care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Diastolic Outcome Measure
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a greater reduction in mean 24-hr diastolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period?
Sleep efficiency
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
Sleep onset latency
Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
PSQI
Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
SCI
Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
ISI
Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks

Full Information

First Posted
March 8, 2013
Last Updated
September 1, 2014
Sponsor
University College Hospital Galway
Collaborators
Health Research Board, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT01809821
Brief Title
Sleep to Lower Elevated Blood Pressure
Acronym
SLEPT
Official Title
Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway
Collaborators
Health Research Board, Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Sleep Disorders, Insomnia, Cardiovascular Diseases
Keywords
Hypertension, Sleep Disorders, Insomnia, Cardiovascular Diseases, Internet treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online Sleep Education
Arm Type
Experimental
Arm Description
The sleep intervention is a multi-component online intervention consisting of sleep information and sleep hygiene education, along with behavioural and cognitive components.
Arm Title
Usual CV care
Arm Type
No Intervention
Arm Description
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.
Intervention Type
Behavioral
Intervention Name(s)
Online Sleep Education
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Diastolic Outcome Measure
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a greater reduction in mean 24-hr diastolic blood pressure in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8-week period?
Time Frame
8 weeks
Title
Sleep efficiency
Description
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
Time Frame
8 weeks
Title
Sleep onset latency
Description
Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
Time Frame
8 weeks
Title
PSQI
Description
Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
Time Frame
8 weeks
Title
SCI
Description
Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
Time Frame
8 weeks
Title
ISI
Description
Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in body mass index in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Plasma lipoproteins
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in plasma lipids in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Plasma HbA1c
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in plasma HbA1c in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
eGFR
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in eGFR in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Insomnia Severity Index
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Insomnia Severity Index Score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Sleep Condition Indicator Score
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Sleep Condition Indicator Score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Pittsburgh Sleep Quality Index in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Mean number of cigarettes smoked
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in mean number of cigarettes smoked in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Sleep onset latency
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in sleep onset latency in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Wake time to sleep onset
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in wake time to sleep onset in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Sleep efficiency
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in sleep efficiency in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Beck Depression Inventory score
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Beck Depression Inventory score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Beck Anxiety Inventory score
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with greater improvements in Beck Anxiety Inventory score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Smoking status
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in smoking status compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Diastolic blood pressure
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in daytime (peak and mean) diastolic blood pressure , compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Systolic blood pressure
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in daytime (peak and mean) systolic blood pressure , compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Total Sleep Time
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in Total Sleep Time , compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Diastolic blood pressure
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in nighttime (peak and mean) diastolic blood pressure , compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Systolic blood pressure
Description
Is the addition of a multi-component online sleep intervention to usual care (standard CV risk factor education), associated with a change in nighttime (peak and mean) systolic blood pressure , compared to usual care alone, over an 8 week period?
Time Frame
8 weeks
Title
Systolic blood pressure
Description
Is the level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks
Time Frame
8 weeks
Title
Systolic blood pressure
Description
To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin J O'Donnell, MB PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
HRB Clinical Research Facility Galway
City
Galway
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25300874
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.
Results Reference
derived

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Sleep to Lower Elevated Blood Pressure

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