Melatonin Supplements for Improving Sleep in Individuals With Hypertension

Hypertension Clinical Trial

Official title:

Melatonin Supplementation in Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238108
• Other study ID #: R21AT002713
• Secondary ID: R21AT002713
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2005
• Last updated: October 13, 2017
• Start date: October 2005
• Est. completion date: August 2010

Study information

• Verified date: October 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• Melatonin
2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Scheer FA, Van Montfrans GA, van Someren EJ, Mairuhu G, Buijs RM. Daily nighttime melatonin reduces blood pressure in male patients with essential hypertension. Hypertension. 2004 Feb;43(2):192-7. Epub 2004 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)	Measurement after 3 weeks of supplementation
Secondary	Change in Systolic Blood Pressure	Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring	Measurement after 3 weeks of supplementation compared to baseline