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OpenTrials
Completed

NCT Number: NCT01809821

Sleep to Lower Elevated Blood Pressure

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HRB Clinical Research Facility Galway

Galway, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online Sleep Education

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Diastolic Outcome Measure

    Time frame: 8 weeks

    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?

  2. Sleep efficiency

    Time frame: 8 weeks

    Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks

  3. Sleep onset latency

    Time frame: 8 weeks

    Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks

  4. PSQI

    Time frame: 8 weeks

    Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks

  5. SCI

    Time frame: 8 weeks

    Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks

  6. ISI

    Time frame: 8 weeks

    Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks

Other outcomes

  1. Body Mass Index

    Time frame: 8 weeks

    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?

  2. Plasma lipoproteins

    Time frame: 8 weeks

    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?

  3. Plasma HbA1c

    Time frame: 8 weeks

    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?

  4. eGFR

    Time frame: 8 weeks

    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?

  5. Insomnia Severity Index

    Time frame: 8 weeks

    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?

  6. Sleep Condition Indicator Score

    Time frame: 8 weeks

    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?

  7. Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

    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?

  8. Mean number of cigarettes smoked

    Time frame: 8 weeks

    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?

  9. Sleep onset latency

    Time frame: 8 weeks

    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?

  10. Wake time to sleep onset

    Time frame: 8 weeks

    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?

  11. Sleep efficiency

    Time frame: 8 weeks

    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?

  12. Beck Depression Inventory score

    Time frame: 8 weeks

    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?

  13. Beck Anxiety Inventory score

    Time frame: 8 weeks

    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?

  14. Smoking status

    Time frame: 8 weeks

    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?

  15. Diastolic blood pressure

    Time frame: 8 weeks

    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?

  16. Systolic blood pressure

    Time frame: 8 weeks

    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?

  17. Total Sleep Time

    Time frame: 8 weeks

    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?

  18. Diastolic blood pressure

    Time frame: 8 weeks

    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?

  19. Systolic blood pressure

    Time frame: 8 weeks

    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?

  20. Systolic blood pressure

    Time frame: 8 weeks

    Is the level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks

  21. Systolic blood pressure

    Time frame: 8 weeks

    To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Collaborators

  • Health Research Board, Ireland

Registry information

Official study title

Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial

Acronym: SLEPT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 13, 2013
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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