Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:42 AM
Study NCT ID:
NCT03066518
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2017-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Melatonin on Sleep Quality in Patients Dementia
Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Organization:
Study Overview
Official Title:
A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia
Status:
COMPLETED
Status Verified Date:
2017-02
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:
Introduction: Patients with dementia may suffer from poor sleep quality. Disturbance in the metabolism melatonin may have a role in the pathogenesis of sleep-wake cycle alterations in dementia.
Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.
Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.
Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).
Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.
Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).
Objective: To evaluate the efficacy of low dose exogenous melatonin in improving sleep quality.
Design: A single-center randomized, double-blinded, placebo-controlled study carried out on outpatients with dementia and sleep alterations.
Participants: The investigators calculated a 40 individuals aged 65 years or over with a diagnosis of mild-moderate dementia (Clinical Dementia Rating 1-2).
Intervention: Patients were randomized to receive either 5 mg of melatonin or placebo every night for 8 weeks.
Measurements: The primary outcome was sleep quality according to the Pittsburgh Sleep Quality Index (PSQI).
Detailed Description:
This is a single-center study. The study protocol, informed consents, and amendments were approved in writing by the appropriate local site Independent Ethics Committee (IEC)/Institutional Review Boards (IRB) (Ethics Committee of the Universidad Autónoma de Nuevo León, School of Medicine).
The patients were recruited as outpatients from the Geriatrics Clinic. A total of 67 patients were screened out of which 40 male and female patients diagnosed with mild to moderate dementia were recruited to the study. Following inclusion, all patients underwent randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. To prevent bias, matching placebo tablets, which were identical in appearance, taste, and odor, were used. The treatment was double-blinded, with two parallel treatment groups. Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.
The patients were recruited as outpatients from the Geriatrics Clinic. A total of 67 patients were screened out of which 40 male and female patients diagnosed with mild to moderate dementia were recruited to the study. Following inclusion, all patients underwent randomization to treatment with melatonin (5 mg orally) or placebo for 8 weeks. To prevent bias, matching placebo tablets, which were identical in appearance, taste, and odor, were used. The treatment was double-blinded, with two parallel treatment groups. Selection for a treatment group was determined by a computer-generated randomization list, in a 1:1 ratio using the randomized permuted blocks method.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: