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Melatonin Supplements for Improving Sleep in Individuals With Hypertension

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00238108
First received: October 11, 2005
Last updated: August 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Sleep Disorders
Hypertension
 Drug: Melatonin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Supplementation in Hypertensive Patients

Resource links provided by NLM:

Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Sleep Quality [ Time Frame: Measurement after 3 weeks of supplementation ] [ Designated as safety issue: No ]
    Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)


Secondary Outcome Measures:
  • Change in Blood Pressure [ Time Frame: measured before, during, and after each inpatient phase ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
 Drug: Placebo
Placebo

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238108

Locations
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 Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Frank AJ Scheer, PhD Brigham and Women's Hospital, Harvard Medical School
  More Information

Publications:

Additional 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: R21 AT002713, R21AT002713, R21 AT002713
Study First Received: October 11, 2005
Results First Received: June 18, 2012
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Sleep disorders
High blood pressure

Additional relevant MeSH terms:
Hypertension
Sleep Disorders
Parasomnias
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
 Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013