Sleep to Lower Elevated Blood Pressure (SLEPT)
This study is currently recruiting participants.
Verified May 2013 by University College Hospital Galway
Sponsor:
University College Hospital Galway
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Dr. Emer McGrath, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01809821
First received: March 8, 2013
Last updated: May 21, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension Sleep Disorders Insomnia Cardiovascular Diseases |
Behavioral: Online Sleep Education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University College Hospital Galway:
Primary Outcome Measures:
- Systolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
Other Outcome Measures:
- Body Mass Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Plasma lipoproteins [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Plasma HbA1c [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- eGFR [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Insomnia Severity Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Sleep Condition Indicator Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Pittsburgh Sleep Quality Index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Mean number of cigarettes smoked [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Sleep onset latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Wake time to sleep onset [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Sleep efficiency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Beck Depression Inventory score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Beck Anxiety Inventory score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Smoking status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Diastolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Systolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
- Total Sleep Time [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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?
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: Online Sleep Education |
|
No Intervention: Usual CV care
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed written informed consent
- ≥18 years on entry to study
- Average automated SBP monitor readings between 140 - 160 mmHg with average automated DBP monitor readings <110 mmHg on three occasions, measured in a valid standardized manner while seated.
- Self-reported difficulty getting to sleep (defined as usually taking more than 30mins to get to sleep), and/or staying asleep (usually wakes-up more two or more times per night) for at least 3 months duration
- Internet access and self-reported competency in using the internet
Exclusion Criteria:
- Currently receiving antihypertensive medication
- Previous history of myocardial infarction, ischaemic stroke or transient ischaemic attack
- Previous history of congestive heart failure or history of dialysis for chronic renal impairment
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809821
Contacts
| Contact: Emer McGrath, MB | 0035391494367 | |
| Contact: Alice Power, MSc | 0035391494282 |
Locations
| Ireland | |
| HRB Clinical Research Facility Galway | Recruiting |
| Galway, Ireland | |
| Principal Investigator: Martin J O'Donnell, MB, PhD | |
| Principal Investigator: Emer R McGrath, MB | |
Sponsors and Collaborators
University College Hospital Galway
Health Research Board, Ireland
Investigators
| Principal Investigator: | Martin J O'Donnell, MB PhD | National University of Ireland Galway |
More Information
No publications provided
| Responsible Party: | Dr. Emer McGrath, Dr.Emer McGrath, University College Hospital Galway |
| ClinicalTrials.gov Identifier: | NCT01809821 History of Changes |
| Other Study ID Numbers: | HRBCRFG-150213-EMG |
| Study First Received: | March 8, 2013 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Ireland: Research Ethics Committee |
Keywords provided by University College Hospital Galway:
|
Hypertension Sleep Disorders Insomnia Cardiovascular Diseases Internet treatment |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Sleep Disorders Parasomnias Sleep Initiation and Maintenance Disorders Vascular Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms Mental Disorders Sleep Disorders, Intrinsic Dyssomnias |
ClinicalTrials.gov processed this record on May 23, 2013