Effect of Melatonin on Sleep Quality in Patients Dementia

Dementia Clinical Trial

Official title:

A Randomized Placebo-controlled Trial Evaluating the Effect of Melatonin on Sleep Quality in Patients With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066518
• Other study ID #: GE15-002
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2017
• Last updated: February 23, 2017
• Start date: January 15, 2016
• Est. completion date: January 25, 2017

Study information

• Verified date: February 2017
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria:

• Older than 60 years;

• 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:

• They had other diagnoses of sleep disorders, known hypersensitivity to melatonin, use of stimulants or hypnotics, recent diagnosis (within 8 weeks) of mood disorders or neuropsychiatric symptoms.

Related Conditions & MeSH terms

• Dementia
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• Melatonin 5 mg

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

References & Publications (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. Review. — View Citation

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. — View Citation

Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011 Mar;21(1):41-53. doi: 10.1007/s11065-010-9154-6. Review. — View Citation

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. — View Citation

McCleery J, Cohen DA, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2016 Nov 16;11:CD009178. Review. — View Citation

Neikrug AB, Ancoli-Israel S. Sleep disorders in the older adult - a mini-review. Gerontology. 2010;56(2):181-9. doi: 10.1159/000236900. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index	A self-administered questionnaire that provides an overall rating of sleep quality.	8 weeks
Secondary	Minimental test	The original purpose is to allow physicians to standardize and quantify cognitive status.	baseline and to the 8 weeks