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Melatonin Supplements for Improving Sleep in Individuals With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238108
First Posted: October 13, 2005
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
Frank AJL Scheer, PhD, Brigham and Women's Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Supplementation in Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Frank AJL Scheer, PhD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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:
  • 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


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

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
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
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


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 Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Frank AJ Scheer, PhD Brigham and Women's Hospital, Harvard Medical School
  More Information

Publications:
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 Submitted: October 11, 2005
First Posted: October 13, 2005
Results First Submitted: June 18, 2012
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:
Hypertension
Sleep Wake Disorders
Parasomnias
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants