Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230737
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2005-09-12
Brief Title:
Effects of Melatonin on Insomnia Symptoms in Older Adults
Sponsor:
Nalaka Gooneratne
Organization:
University of Pennsylvania
Study Overview
Official Title:
Melatonin Randomized Trial for Insomnia in the Elderly
Status:
COMPLETED
Status Verified Date:
2017-01
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 determine whether melatonin tablets will increase the sleep of older adults with insomnia
Detailed Description:
Melatonin is a hormone secreted predominantly during the sleep period suspected to have a strong link to the circadian sleep-wake cycle Melatonin is also available in a pill form and when administered during the day tends to have a sedative effect Clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia regardless of their endogenous melatonin levels Data indicate however that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin Generally melatonin levels decrease with age therefore older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep This study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep
Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints the beginning of Week 1 and the end of Week 6 At study entry participants will be admitted to the General Clinical Research Center for a 3-night stay beginning with an overnight urine screen to confirm low melatonin levels Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity the diary will be used throughout the study During Night 1 at the clinic participants will have urine samples collected throughout the night Night 2 will be an adaptation night to allow participants to get used to their surroundings On Night 3 participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency Participants with sleep efficiencies of 80 or higher will complete their study participation Participants with sleep efficiencies less than 80 will be randomly assigned to one of three study treatments daily for 6 weeks high-dose melatonin 40 mg low-dose melatonin 04 mg or placebo Participants will have study visits at Weeks 1 3 and 6 to monitor for adverse events After 6 weeks participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study Sleep questionnaires cognitive tests and psychomotor tests will be used to assess participants at the beginning of the study after 6 weeks and at the end of the study One month after the end of the study participants will have a follow-up visit to be reassessed for adverse events
Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints the beginning of Week 1 and the end of Week 6 At study entry participants will be admitted to the General Clinical Research Center for a 3-night stay beginning with an overnight urine screen to confirm low melatonin levels Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity the diary will be used throughout the study During Night 1 at the clinic participants will have urine samples collected throughout the night Night 2 will be an adaptation night to allow participants to get used to their surroundings On Night 3 participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency Participants with sleep efficiencies of 80 or higher will complete their study participation Participants with sleep efficiencies less than 80 will be randomly assigned to one of three study treatments daily for 6 weeks high-dose melatonin 40 mg low-dose melatonin 04 mg or placebo Participants will have study visits at Weeks 1 3 and 6 to monitor for adverse events After 6 weeks participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study Sleep questionnaires cognitive tests and psychomotor tests will be used to assess participants at the beginning of the study after 6 weeks and at the end of the study One month after the end of the study participants will have a follow-up visit to be reassessed for adverse events
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 |
|---|---|---|---|
| R01AT001521-01A1 | NIH | None | httpsreporternihgovquickSearchR01AT001521-01A1 |