Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238108
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2005-10-11
Brief Title:
Melatonin Supplements for Improving Sleep in Individuals With Hypertension
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Melatonin Supplementation in Hypertensive Patients
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Hypertension or high blood pressure is a condition in which an individuals 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT002713 | NIH | None | httpsreporternihgovquickSearchR21AT002713 |