Hypertension, Sleep Disorders
Conditions
Keywords
Sleep disorders, High blood pressure
Brief summary
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.
Detailed description
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.
Interventions
DRUGMelatonin
2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
DRUGPlacebo
Placebo
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with uncomplicated hypertension * Currently being treated with Atenolol (a beta-blocker)
Exclusion criteria
* History of medical illness other than essential hypertension * Personal or family history of psychiatric illness * Current use of any medication other than anti-hypertensive drugs * Any recent travel across time zones * History of working various shifts on an irregular basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | Measurement after 3 weeks of supplementation | Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Measurement after 3 weeks of supplementation compared to baseline | Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Melatonin Melatonin | 8 |
| Placebo Placebo | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Placebo | Melatonin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 5.7 | 56 years STANDARD_DEVIATION 6.9 | 56 years STANDARD_DEVIATION 6.1 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Sleep Quality
Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)
Time frame: Measurement after 3 weeks of supplementation
Population: One subject was removed from analysis because of an unstable dose of prescription medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Melatonin | Sleep Quality | 88.1 % (% asleep during 8 hour opportunity) | Standard Error 2.7 |
| Placebo | Sleep Quality | 80.5 % (% asleep during 8 hour opportunity) | Standard Error 2.6 |
Secondary
Change in Systolic Blood Pressure
Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring
Time frame: Measurement after 3 weeks of supplementation compared to baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Melatonin | Change in Systolic Blood Pressure | -0.2 mmHg | Standard Error 2.7 |
| Placebo | Change in Systolic Blood Pressure | -0.4 mmHg | Standard Error 2.7 |