Sleep to Lower Elevated Blood Pressure (SLEPT)

This study has been completed.
Sponsor:
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: September 1, 2014
Last verified: September 2014

March 8, 2013
September 1, 2014
May 2013
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01809821 on ClinicalTrials.gov Archive Site
  • 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?
  • Sleep efficiency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
  • Sleep onset latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
  • PSQI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks
  • SCI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
  • ISI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
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?
  • 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?
  • 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 nighttime (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 nighttime (peak and mean) systolic 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 level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks
  • Systolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
  • 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 lipids [ 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?
  • Montreal cognitive assessment 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 Montreal cognitive assessment score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
  • Digit symbol substitution test 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 Digit symbol substitution test score in patients with hypertension and poor sleep quality, compared to usual care alone, over an 8 week period?
 
Sleep to Lower Elevated Blood Pressure
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • Sleep Disorders
  • Insomnia
  • Cardiovascular Diseases
Behavioral: Online Sleep Education
  • 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.
    Intervention: 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT01809821
HRBCRFG-150213-EMG
No
Dr. Emer McGrath, University College Hospital Galway
University College Hospital Galway
Health Research Board, Ireland
Principal Investigator: Martin J O'Donnell, MB PhD National University of Ireland Galway
University College Hospital Galway
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP