Sleep to Lower Elevated Blood Pressure

Hypertension Clinical Trial

— SLEPT  

Official title:

Sleep to Lower Elevated Blood Pressure: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809821
• Other study ID #: HRBCRFG-150213-EMG
• Status: Completed
• Phase: N/A
• First received: March 8, 2013
• Last updated: September 1, 2014
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Insomnia
• Parasomnias
• Sleep Disorders

Intervention

Behavioral:
• Online Sleep Education

Locations

Country	Name	City	State
Ireland	HRB Clinical Research Facility Galway	Galway

Sponsors (2)

Lead Sponsor	Collaborator
University College Hospital Galway	Health Research Board, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index	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?	8 weeks	No
Other	Plasma lipoproteins	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?	8 weeks	No
Other	Plasma HbA1c	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?	8 weeks	No
Other	eGFR	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?	8 weeks	No
Other	Insomnia Severity Index	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?	8 weeks	No
Other	Sleep Condition Indicator Score	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?	8 weeks	No
Other	Pittsburgh Sleep Quality Index	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 weeks	No
Other	Mean number of cigarettes smoked	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?	8 weeks	No
Other	Sleep onset latency	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?	8 weeks	No
Other	Wake time to sleep onset	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?	8 weeks	No
Other	Sleep efficiency	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?	8 weeks	No
Other	Beck Depression Inventory score	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?	8 weeks	No
Other	Beck Anxiety Inventory score	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?	8 weeks	No
Other	Smoking status	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?	8 weeks	No
Other	Diastolic blood pressure	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?	8 weeks	No
Other	Systolic blood pressure	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?	8 weeks	No
Other	Total Sleep Time	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?	8 weeks	No
Other	Diastolic blood pressure	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?	8 weeks	No
Other	Systolic blood pressure	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?	8 weeks	No
Other	Systolic blood pressure	Is the level of adherence to a multi-component online sleep intervention associated with a change in mean 24-hour SBP over 8 weeks	8 weeks	No
Other	Systolic blood pressure	To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .	8 weeks	No
Primary	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.	8 weeks	No
Secondary	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?	8 weeks	No
Secondary	Sleep efficiency	Change in proportion of participants with sleep efficacy = 85% at 8 weeks	8 weeks	No
Secondary	Sleep onset latency	Change in proportion of participants with sleep onset latency = 30 minutes at 8 weeks	8 weeks	No
Secondary	PSQI	Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks	8 weeks	No
Secondary	SCI	Change in proportion of participants with sleep condition indicator (SCI) score =5.9 at 8 weeks	8 weeks	No
Secondary	ISI	Change in proportion of participants with Insomnia Severity index (ISI) score =15 at 8 weeks	8 weeks	No