The Impact of Music Intervention on Sleep

Официальное название

The Impact of Music Intervention on Sleep: CoMPoSER Trial

Обзор

The primary purpose of this Stage 1b NIH-funded clinical trial (K23AG073618, PI Petrovsky) is to determine the efficacy of a 1-month music intervention (Calming Music Personalized for Sleep Enhancement in PeRsons living with Dementia, CoMPoSER) on health outcomes in 72 dyads (144 participants) of persons living with dementia (PLWD) and their caregivers (Stage 1b). The secondary purpose of this research project is to examine the mechanism of stress reduction and sustained effects of the music intervention on PLWD and caregiver well-being. We will evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT and determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.

Подробное описание

Aim 1: Evaluate the acceptability of the mobile application CoMPoSER in a pilot RCT.

Aim 2: Determine the impact of the mobile application CoMPoSER on PLWD (sleep latency, sleep efficiency, wake after sleep onset, total sleep time, sleep quality) and caregiver (perceived stress and well-being) outcomes.

Aim 3: Examine stress reduction as a mechanism of action measured via salivary cortisol by which 1-month long CoMPoSER intervention affects insomnia symptoms in PLWD.

Aim 4: To determine the sustained (3 months) efficacy of CoMPoSER compared to control group on PLWD and caregiver health outcomes.

Вмешательства

• Другое CoMPoSER intervention group
  Participants in the intervention will use a mobile application that plays calming music personalized for sleep enhancement, relaxation techniques and nighttime routine guidance.
• Другое Sleep Education
  Participants in this intervention will receive sleep education based on the NIH/NIA guide, which includes tips for getting a good night's sleep.

Первичные конечные точки

• Acceptability [Срок оценки: 4 weeks]

Вторичные конечные точки (6)

• PLWD Objective Sleep Outcomes [Срок оценки: 1 month, 3 months]
• PLWD Subjective Sleep Outcomes [Срок оценки: 1 month, 3 months]
• Caregiver Stress Outcome [Срок оценки: 1 month, 3 months]
• Caregiver Wellbeing Outcome (Burden) [Срок оценки: 1 month, 3 months]
• Caregiver Wellbeing Outcome (Depression) [Срок оценки: 1 month, 3 months]
• Stress Change [Срок оценки: 1 month]

Критерии участия

Inclusion Criteria for persons living with dementia (PLWD):

• Age 60 and above
• Existing physician diagnosis of dementia or self-reported memory impairment and Clinical Dementia Rating Scale score of greater than 0.5,
• Score of >10 on the Insomnia Severity Index
• Stable dose of psychotropic medications
• Agreeing to wear an actiwatch for the duration of the study

PLWD Exclusion Criteria:

• Hearing impairment
• Planned transition to a residential or institutional care facility in 3 months
• Presence of extrapyramidal symptoms or acute sleep disruption
• Bed bound
• Living in an alternative home setting (such as Assisted Living Community)

Informal caregivers inclusion criteria:

• Age 18 and above.
• Providing at least 4 hours of daily care
• Living with PLWD
• Able to read and communicate in English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Duke University School of Nursing — Durham

Публикации

• Vitiello MV, Borson S. Sleep disturbances in patients with Alzheimer's disease: epidemiology, pathophysiology and treatment. CNS Drugs. 2001;15(10):777-96. doi: 10.2165/00023210-200115100-00004. PMID 11602004
• Petrovsky DV, Ramesh P, McPhillips MV, Hodgson NA. Effects of music interventions on sleep in older adults: A systematic review. Geriatr Nurs. 2021 Jul-Aug;42(4):869-879. doi: 10.1016/j.gerinurse.2021.04.014. Epub 2021 Jun 2. PMID 34090233
• Cheour S, Cheour C, Kilani C, Guemri A, Zineddine D, Khelifa R, Supriya R, Bragazzi NL, Cheour F, Baker JS, Gaied-Chortane S. Salivary Testosterone and Cortisol Levels in Tunisian Elderly Male Patients With Mild Alzheimer's Disease. Implications of Musical Therapy And/Or Physical Rehabilitation. Front Physiol. 2022 Aug 5;13:839099. doi: 10.3389/fphys.2022.839099. eCollection 2022. PMID 35991172
• Takahashi T, Matsushita H. Long-term effects of music therapy on elderly with moderate/severe dementia. J Music Ther. 2006 Winter;43(4):317-33. doi: 10.1093/jmt/43.4.317. PMID 17348758
• Gooneratne NS, Vitiello MV. Sleep in older adults: normative changes, sleep disorders, and treatment options. Clin Geriatr Med. 2014 Aug;30(3):591-627. doi: 10.1016/j.cger.2014.04.007. Epub 2014 Jun 12. PMID 25037297
• Shum A, Taylor BJ, Thayala J, Chan MF. The effects of sedative music on sleep quality of older community-dwelling adults in Singapore. Complement Ther Med. 2014 Feb;22(1):49-56. doi: 10.1016/j.ctim.2013.11.003. Epub 2013 Nov 14. PMID 24559816

Идентификаторы

NCT: NCT06088810 · PRO00115115 · 1K23AG073618-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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