Effect of Melatonin on Sleep Quality in Patients Dementia
NCT ID: NCT03066518
Last Updated: 2017-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2016-01-15
2017-01-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Melatonin
Melatonin 5 mg, daily, eight weeks
Melatonin 5 mg
placebo
Placebo, daily, eight weeks
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Melatonin 5 mg
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Circadian cycle sleep disorder with insomnia (according to Diagnostic and Statistical Manual of Mental Disorders- V criteria);
* Mild or moderate dementia (clinical dementia rating 1 and 2);
* Medications such as anti-depressants, acetylcholinesterase inhibitors, antipsychotics or memantine were allowed as long as they were initiated for over 8 weeks.
Exclusion Criteria
60 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario Dr. Jose E. Gonzalez
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rocio Morales Delgado
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guillermo Guajardo, MD
Role: STUDY_DIRECTOR
HUGonzález
References
Explore related publications, articles, or registry entries linked to this study.
Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Epub 2011 Jan 12.
Neikrug AB, Ancoli-Israel S. Sleep disorders in the older adult - a mini-review. Gerontology. 2010;56(2):181-9. doi: 10.1159/000236900. Epub 2009 Sep 9.
Beaulieu-Bonneau S, Hudon C. Sleep disturbances in older adults with mild cognitive impairment. Int Psychogeriatr. 2009 Aug;21(4):654-66. doi: 10.1017/S1041610209009120. Epub 2009 May 11.
Woods DL, Phillips LR, Martin JL. Biological basis for sleep disturbance and behavioral symptoms in dementia: a biobehavioral model. Res Gerontol Nurs. 2011 Oct;4(4):281-93. doi: 10.3928/19404921-20110302-01. Epub 2011 Mar 16.
Guarnieri B, Cerroni G, Sorbi S. Sleep disturbances and cognitive decline: recommendations on clinical assessment and the management. Arch Ital Biol. 2015 Jun-Sep;153(2-3):225-30. doi: 10.12871/0003982920152347.
Ooms S, Ju YE. Treatment of Sleep Disorders in Dementia. Curr Treat Options Neurol. 2016 Sep;18(9):40. doi: 10.1007/s11940-016-0424-3.
Xu J, Wang LL, Dammer EB, Li CB, Xu G, Chen SD, Wang G. Melatonin for sleep disorders and cognition in dementia: a meta-analysis of randomized controlled trials. Am J Alzheimers Dis Other Demen. 2015 Aug;30(5):439-47. doi: 10.1177/1533317514568005.
McCleery J, Cohen DA, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2016 Nov 16;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub3.
Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532.
Morales-Delgado R, Camara-Lemarroy CR, Salinas-Martinez R, Gamez-Trevino D, Arredondo-Jaime A, Hernandez-Maldonado E, Guajardo-Alvarez G. A randomized placebo-controlled trial evaluating the effect of melatonin on sleep quality in patients with mild-moderate dementia. Eur Geriatr Med. 2018 Aug;9(4):449-454. doi: 10.1007/s41999-018-0068-9. Epub 2018 May 24.
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GE15-002
Identifier Type: -
Identifier Source: org_study_id