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Completed

NCT Number: NCT00238108

Melatonin Supplements for Improving Sleep in Individuals With Hypertension

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.

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Key information

Conditions

Sleep Disorders Cardiovascular Diseases Hypertension Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Vascular Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks

Other names: N-acetyl-5-methoxytryptamine

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Office of Dietary Supplements (ODS)

Registry information

Official study title

Melatonin Supplementation in Hypertensive Patients

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Oct 13, 2005
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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