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| Name | Class |
|---|---|
| Health Research Board, Ireland | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual CV care | No Intervention | Specialist nurses will administer the CV risk factor education intervention to participants in small groups over one hour. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Sleep Education | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma lipoproteins |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin J O'Donnell, MB PhD | National University of Ireland, Galway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRB Clinical Research Facility Galway | Galway | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25300874 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Sleep efficiency |
Change in proportion of participants with sleep efficacy ≥ 85% at 8 weeks |
| 8 weeks |
| Sleep onset latency | Change in proportion of participants with sleep onset latency ≤ 30 minutes at 8 weeks | 8 weeks |
| PSQI | Change in proportion of participants with Pittsburgh Sleep Quality Index (PSQI) score <5 over 8 weeks | 8 weeks |
| SCI | Change in proportion of participants with sleep condition indicator (SCI) score ≤5.9 at 8 weeks | 8 weeks |
| ISI | Change in proportion of participants with Insomnia Severity index (ISI) score ≥15 at 8 weeks | 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? |
| 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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? | 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 | 8 weeks |
| Systolic blood pressure | To determine if concomitant use of antihypertensive medication influences the change in mean 24-hour SBP over 8 weeks . | 8 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |