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Melatonin Supplements for Improving Sleep in Individuals With Hypertension

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ClinicalTrials.gov Identifier: NCT00238108
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : September 25, 2012
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Sleep Disorders Hypertension Drug: Melatonin Drug: Placebo Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Supplementation in Hypertensive Patients
Study Start Date : October 2005
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks)
Drug: Melatonin
2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
Other Name: N-acetyl-5-methoxytryptamine
Placebo Comparator: 2
Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Sleep Quality [ Time Frame: 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 Outcome Measures :
  1. Change in Systolic Blood Pressure [ Time Frame: Measurement after 3 weeks of supplementation compared to baseline ]
    Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238108

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Principal Investigator: Frank AJ Scheer, PhD Brigham and Women's Hospital, Harvard Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank AJL Scheer, PhD, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00238108     History of Changes
Other Study ID Numbers: R21AT002713 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2005    Key Record Dates
Results First Posted: September 25, 2012
Last Update Posted: November 14, 2017
Last Verified: October 2017

Keywords provided by Frank AJL Scheer, PhD, Brigham and Women's Hospital:
Sleep disorders
High blood pressure

Additional relevant MeSH terms:
Sleep Wake Disorders
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants