HypertensionSLEPTNCT01809821
Sleep to Lower Elevated Blood Pressure
A study testing Online Sleep Education in people with Hypertension and Sleep Disorders, run by University College Hospital Galway at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Sleep Disorders, Insomnia
- What is being tested?
- Online Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteIreland
- Study dates
- May 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
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
- Being tested
- Online Sleep Education
- Keywords
- Hypertension, Sleep Disorders, Insomnia, Cardiovascular Diseases, Internet treatment
- Medical subject headings
- Hypertension, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Sleep EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
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?
Measured: 8 weeks
Sleep efficiency
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
Measured: 8 weeks
Sleep onset latency
Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
Measured: 8 weeks
PSQI
Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
Measured: 8 weeks
SCI
Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
Measured: 8 weeks
ISI
Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Dr. Emer McGrath, University College Hospital Galway
- Investigators
- Martin J O'Donnell, MB PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809821
- Sponsor's protocol ID
- HRBCRFG-150213-EMG
- Acronym
- SLEPT
- Status last verified
- Sep 2014
- First submitted
- 8 Mar 2013
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25300874
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01809821
- Acronym / sponsor ID
- SLEPT / HRBCRFG-150213-EMG
- Conditions
- Hypertension, Sleep Disorders, Insomnia, Cardiovascular Diseases
- Keywords
- Hypertension, Sleep Disorders, Insomnia, Cardiovascular Diseases, Internet treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Sleep Education | Experimental | Behavioral: Online Sleep EducationThe sleep intervention is a multi-component online intervention consisting of sleep information and sleep hygiene education, along with behavioural and cognitive components. |
| Usual CV care | No intervention | –Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Sleep Education | Behavioural | Online Sleep Education |
Primary outcome
Systolic Blood Pressure
Time frame: 8 weeks
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.
6 secondary outcomes
Diastolic Outcome Measure
Time frame: 8 weeks
Sleep efficiency
Time frame: 8 weeks
Sleep onset latency
Time frame: 8 weeks
PSQI
Time frame: 8 weeks
SCI
Time frame: 8 weeks
ISI
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
- Derived from this study: PubMed 25300874McGrath 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin J O'Donnell, MB PhD principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Sleep Education in people with Hypertension and Sleep Disorders, run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01809821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.