Melatonin Supplements for Improving Sleep in Individuals With Hypertension
NCT ID: NCT00238108
Last Updated: 2017-11-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2005-10-31
2010-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks)
Melatonin
2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
2
Placebo
Placebo
Placebo
Interventions
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Melatonin
2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently being treated with Atenolol (a beta-blocker)
Exclusion Criteria
* 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
35 Years
65 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Office of Dietary Supplements (ODS)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Frank AJL Scheer, PhD
Assistant Professor of Medicine
Principal Investigators
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Frank AJ Scheer, PhD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Harvard Medical School
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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