Trial Outcomes & Findings for Melatonin Supplements for Improving Sleep in Individuals With Hypertension (NCT NCT00238108)

Results Overview

Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Measurement after 3 weeks of supplementation

Results posted on

2017-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Melatonin Melatonin	Placebo Placebo
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Melatonin Supplements for Improving Sleep in Individuals With Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Melatonin n=8 Participants Melatonin	Placebo n=8 Participants Placebo	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 6.9 • n=5 Participants	56 years STANDARD_DEVIATION 5.7 • n=7 Participants	56 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Measurement after 3 weeks of supplementation

Population: One subject was removed from analysis because of an unstable dose of prescription medication.

Sleep efficiency as measured by polysomnography (total time asleep as a percentage of the 8-hour sleep opportunity)

Outcome measures

Outcome measures
Measure	Melatonin n=7 Participants Melatonin	Placebo n=8 Participants Placebo
Sleep Quality	88.1 % (% asleep during 8 hour opportunity) Standard Error 2.7	80.5 % (% asleep during 8 hour opportunity) Standard Error 2.6

SECONDARY outcome

Timeframe: Measurement after 3 weeks of supplementation compared to baseline

Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring

Outcome measures

Outcome measures
Measure	Melatonin n=7 Participants Melatonin	Placebo n=8 Participants Placebo
Change in Systolic Blood Pressure	-0.2 mmHg Standard Error 2.7	-0.4 mmHg Standard Error 2.7

Adverse Events

Melatonin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Frank Scheer

Brigham and Women's Hospital

Phone: 617-732-7014

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place