NCT00238108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2012

Completed
Last Updated

November 14, 2017

Status Verified

October 1, 2017

Enrollment Period

4.8 years

First QC Date

October 11, 2005

Results QC Date

June 18, 2012

Last Update Submit

October 13, 2017

Conditions

Sleep DisordersHypertension

Keywords

Sleep disordersHigh blood pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Systolic Blood Pressure

    Measurement after 3 weeks of supplementation compared to baseline

Study Arms (2)

1

EXPERIMENTAL

Melatonin (2,5 mg, by mouth, 1 per day, for 3-4 weeks)

Drug: Melatonin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MelatoninDRUG

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

Also known as: N-acetyl-5-methoxytryptamine
1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with uncomplicated hypertension
  • Currently being treated with Atenolol (a beta-blocker)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • 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. doi: 10.1161/01.HYP.0000113293.15186.3b. Epub 2004 Jan 19.

    PMID: 14732734BACKGROUND

  • Scheer FA, Morris CJ, Garcia JI, Smales C, Kelly EE, Marks J, Malhotra A, Shea SA. Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. Sleep. 2012 Oct 1;35(10):1395-402. doi: 10.5665/sleep.2122.

    PMID: 23024438DERIVED

MeSH Terms

Conditions

Sleep Wake DisordersHypertension

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Dr. Frank Scheer
Organization
Brigham and Women's Hospital
fscheer@rics.bwh.harvard.edu
617-732-7014

Study Officials

  • Frank AJ Scheer, PhD

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 14, 2017

Results First Posted

September 25, 2012

Record last verified: 2017-10

Locations

US(1)