Effect of Melatonin on Sleep Quality in Patients Dementia
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).
Timeline
- Start
- 2016-01-15
- Primary completion
- 2017-01-25
- Completion
- 2017-01-25
Publications
- Background 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.
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- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 5 mg | Oral |