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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT002713 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers.
Hypertension, or high blood pressure, is a condition in which an individual's blood pressure is higher than the normal level. It is estimated that one in three individuals in the United States has high blood pressure, though many do not know it because there are usually no symptoms. Uncontrolled hypertension may lead to stroke, heart attack, heart failure, or kidney failure. Beta-blockers are one class of drugs that have been developed to help lower blood pressure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Many individuals who take beta-blockers for hypertension complain that they have trouble sleeping, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with high blood pressure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in lowering blood pressure.
Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study. Participants will take part in two inpatient phases. Each inpatient stay will last 4 days and will be separated by 3 to 4 weeks. While in the clinic, participants' sleep patterns and core temperature will be recorded and plasma, saliva, and urine samples will be collected. Blood pressure will be measured before and after each inpatient stay, as well as at points during the stay. Throughout the study, participants' activity will be monitored by an accelerometer worn around the wrist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks) |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | 2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity) | Measurement after 3 weeks of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring | Measurement after 3 weeks of supplementation compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank AJ Scheer, PhD | Brigham and Women's Hospital, Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14732734 | Background | Scheer FA, Van Montfrans GA, van Someren EJ, Mairuhu G, Buijs RM. Daily nighttime melatonin reduces blood pressure in male patients with essential hypertension. Hypertension. 2004 Feb;43(2):192-7. doi: 10.1161/01.HYP.0000113293.15186.3b. Epub 2004 Jan 19. | |
| 23024438 | Derived | Scheer FA, Morris CJ, Garcia JI, Smales C, Kelly EE, Marks J, Malhotra A, Shea SA. Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. Sleep. 2012 Oct 1;35(10):1395-402. doi: 10.5665/sleep.2122. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin | Melatonin |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin | Melatonin |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Quality | Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity) | One subject was removed from analysis because of an unstable dose of prescription medication. | Posted | Mean | Standard Error | % (% asleep during 8 hour opportunity) | Measurement after 3 weeks of supplementation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin | Melatonin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Scheer | Brigham and Women's Hospital | 617-732-7014 | fscheer@rics.bwh.harvard.edu |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Placebo |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Change in Systolic Blood Pressure | Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring | Posted | Mean | Standard Error | mmHg | Measurement after 3 weeks of supplementation compared to baseline |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo | Placebo | 0 | 8 | 0 | 8 |
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| D001523 | Mental Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |