Trial · NCT00238108
Melatonin Supplements for Improving Sleep in Individuals With Hypertension
NCT00238108, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2012-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Melatonin Supplements for Improving Sleep in Individuals With Hypertension. Trials, record NCT00238108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00238108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Melatonin Supplements for Improving Sleep in Individuals With Hypertension
- NCT number
- NCT00238108
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Sleep Disorders, Hypertension
- Interventions
- Melatonin, Placebo
- First posted
- 2005-10-13
- Last updated
- 2017-11-14
- Results first posted
- 2012-09-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sleep Quality | 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 | Change in Systolic Blood Pressure | Measurement after 3 weeks of supplementation compared to baseline | Systolic blood pressure as measured by 24-h ambulatory blood pressure monitoring |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sleep Quality | Measurement after 3 weeks of supplementation | One subject was removed from analysis because of an unstable dose of prescription medication. | % (% asleep during 8 hour opportunity) | MEAN |
| SECONDARY | Change in Systolic Blood Pressure | Measurement after 3 weeks of supplementation compared to baseline | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sleep Quality | Melatonin | 88.1 | Standard Error 2.7 | % (% asleep during 8 hour opportunity) | |
| Sleep Quality | Placebo | 80.5 | Standard Error 2.6 | % (% asleep during 8 hour opportunity) | |
| Change in Systolic Blood Pressure | Melatonin | -0.2 | Standard Error 2.7 | mmHg | |
| Change in Systolic Blood Pressure | Placebo | -0.4 | Standard Error 2.7 | mmHg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Melatonin | 8 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Melatonin | 8 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Melatonin | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Melatonin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Melatonin | 0 | 8 |
| Total, other adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Melatonin | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AT002713 | Melatonin Supplementation in Hypertensive Patients | SCHEER, FRANK A | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2005 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Melatonin vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00238108
GET https://conductscience.org/api/trials/v1/NCT00238108/registered