An interventional study of Online Sleep Education in Hypertension, Sleep Disorders and Insomnia, sponsored by University College Hospital Galway. Completed at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-03.
Sponsored by University College Hospital Galway · Not applicable, Interventional, and Treatment
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 134 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →University College Hospital Galway is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour.
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.
Time frame: 8 weeks
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?
Time frame: 8 weeks
Sleep efficiency
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks
Time frame: 8 weeks
Sleep onset latency
Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks
Time frame: 8 weeks
PSQI
Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score \<5 over 8 weeks
Time frame: 8 weeks
SCI
Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks
Time frame: 8 weeks
ISI
Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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?
Time frame: 8 weeks
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
Time frame: 8 weeks
Systolic blood pressure
To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks .
Time frame: 8 weeks
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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University College Hospital Galway