Clinical trial NCT05398419: Music Interventions for the Facilitation of Sleep in the Acute Geriatric Setting
Official title: Music Interventions for the Facilitation of Sleep in the Acute Geriatric Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Insomnia
Music Listening Intervention
Non-musical Sound Listening Intervention
Keywords: Sleep disturbance
Insomnia
Music
Non-musical sounds
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: St. Mary's Hospital Foundation
First posted: 2022-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be a 3-arm randomized controlled trial where participants will be randomized to one of the three following groups: music listening intervention involving instrumental slow tempo music, non-musical sounds involving nature sounds, or standard of care on the Geriatric Assessment Unit (control). The patients will be randomized in equal ratios to the 3 groups. Each intervention will take place over 7 consecutive nights. The music or non-musical sounds will be played throughout the whole night for each patient in those groups.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep disturbance is a common problem experienced by older patients, especially in the acute care setting, and has detrimental effects on patients' health and recovery. There is a keen focus on non-pharmacological interventions because of the high risk of side effects related to pharmacotherapy. Music is safe and cost-effective, and there is a growing body of evidence for its potential health benefits.

The purpose of our study is to examine the impact of music listening interventions on the facilitation of sleep for patients admitted to the geriatric assessment unit (GAU).

The investigators predict that a musical listening exercise will more effectively contribute to the facilitation of sleep compared to non-musical sounds and compared to standard of care on the GAU. The investigators plan to conduct this study as a feasibility study. It will be a 3-arm randomized controlled trial where participants will be randomized to either: (1) music listening intervention, (2) non-musical sounds involving nature sounds, or (3) standard of care on the GAU. The intervention will take place over 7 consecutive nights.

The primary outcome will be sleep quality, which will be measured objectively using sleep logs and subjectively through patients' own perspectives of their sleep through the Insomnia Severity Index. Secondary outcomes will include patients' sleep quality assessed by smart watches, which the investigators will evaluate to see if the data correlates to the sleep logs and patients' subjective view of their sleep. Other secondary outcomes will include patients' mood, level of pain, number medications used for sleep, duration of stay in hospital, patients' level of enjoyment of the music or non-musical sounds, and feasibility measures.

As this is a feasibility study, the goal is to show that it is possible to conduct a larger study with the same objectives and methodology. The ultimate goal is to create high-quality evidence to support (or refute) our hypothesis that music listening interventions are effective at facilitating sleep for patients admitted to the GAU. This would be a safe and cost-effective intervention to improve the health outcomes of this vulnerable population.

Detailed description: Summary of background:

Sleep disturbance is a common problem experienced by older patients, especially in the acute care setting, and has detrimental effects on patients' health and recovery. There is a keen focus on non-pharmacological interventions because of the high risk of side effects related to pharmacotherapy. Music is safe and cost-effective, and there is a growing body of evidence for its potential health benefits.

Purpose:

The purpose of this study is to examine the impact of music listening interventions on the facilitation of sleep and the improvement of sleep quality for patients admitted to the geriatric assessment unit (GAU), as well as the feasibility of applying these interventions.

Hypothesis:

The investigators predict that a musical listening exercise involving instrumental slow-tempo music (STM) will more effectively contribute to the facilitation of sleep compared to non-musical sounds (nature sounds) and compared to standard of care on the GAU which involves an adapted in-hospital approach to geriatric patients.

Methods:

-Study design: The investigators plan to conduct this study as a feasibility study. It will be a 3-arm randomized controlled trial where participants will be randomized to one of the three following groups: music listening intervention involving instrumental STM, non-musical sounds involving nature sounds, or standard of care on the GAU (control). The patients will be randomized in equal ratios to the 3 groups. Each intervention will take place over 7 consecutive nights. The music or non-musical sounds will be played throughout the whole night for each patient in those groups.

The investigators note that patients' medical situation will likely change throughout their hospitalization stay and this may be a confounding factor affecting their sleep. The investigators also note that patients may be discharged prior to completing the 7-day intervention.

-Study outcomes and data collection procedure: See details in section below.

-Study population: See details in section below.

-Recruitment and consent: The investigators will provide the triage questionnaire (which contains the inclusion/exclusion criteria) to the treating physicians on the GAU at SMH to help them determine which patients would be appropriate for this study. The investigators will ask the treating physician to inform the patient that there is a research project on music and sleep and ask the patient if they would be interested in hearing more. If the patient is interested, the treating physician will then inform the research team. The research assistants will then discuss with the treating physicians regarding if the patient is able to consent to the study or not. They will then know whether to seek consent directly from the patient or from their substitute decision maker. In all cases, the research assistant will then approach the patient to explain the research project in detail and confirm the patient's eligibility and interest to participate in the study.

If the patient is deemed eligible based on the inclusion and exclusion criteria, wishes to participate in the study, and deemed capable to consent by their treating physician, the research assistant will obtain the patient's consent directly from them and provide the consent form for them to sign. If the patient's physician had deemed that the patient does not have the capacity to consent, and the patient wishes to participate in the study, the patient's substitute decision maker will be asked for consent on behalf of the patient. The consent will be done by the research assistants, not by the treating physician.

-Sample size: As this is a feasibility study, the investigators aim to enroll around 50 participants in the study, estimating that 2 patients will be enrolled every week. This sample size estimation is based on previous similar studies. A randomized controlled trial conducted in 2017 in the same patient population, specifically patients admitted to the GAU at St. Mary's Hospital, included 36 patients. This study examined the effect of music on patients' health, specifically their emotions and mobility. Furthermore, most of the studies included in two recent systematic reviews and meta-analyses examining the impact of music for the improvement of sleep quality in older patients in the community had sample sizes mostly between 40 and 60 patients.

A power calculation cannot be done as this is a feasibility study and there is too much patient heterogeneity with respect to medical and cognitive status to apply a power analysis from more homogenous study populations to the current study. The investigators plan to use the results of this study to help determine the sample size required to achieve sufficient statistical power in a subsequent larger study with the same objectives and methodology.

-Data analysis: The participants' baseline characteristics will be summarized using means and standard deviations or frequencies and percentages, as appropriate. Between-group comparisons will be performed using unpaired sample t-test, Mann-Whitney, and/or Chi-square test, as appropriate. Multiple linear or logistic regression models will be used to identify whether the interventions influenced sleep outcomes. The investigators will likely also utilize repeated-measure analysis of variance, to assess outcomes in our study.

Dissemination plan:

The investigators plan to publish a manuscript of our results in a suitable specialized journal. The results with also be presented as oral presentations at Medical Grands Rounds at St. Mary's Hospital and Geriatric Medicine Grand Rounds at the MUHC (McGill University Health Centre). Furthermore, the results will be presented at the AMGQ (Association des médecins gériatres du Québec) conference in May 2023.

Expected impact of findings:

As this is a feasibility study, the goal is to show that it is possible to conduct a larger study with the same objectives and methodology. The ultimate goal is to create high-quality evidence to support (or refute) our hypothesis that music listening interventions are effective at facilitating sleep for patients admitted to the GAU. This would be a safe and cost-effective intervention to improve the health outcomes of this vulnerable population.

Eligibility criteria: Inclusion Criteria:

* This study will include patients admitted to the GAU at St. Mary's hospital in Montréal over the six-month study period (March to August 2022). As many of the patients admitted to the GAU have major neurocognitive disorder (MNCD), the investigators will include them in our study (MNCD of any stage, including Alzheimer's disease). Furthermore, the investigators will include patients who take medications for sleep in our study, and they will be randomized into the 3 groups like all the other participants.
* The patients' baseline characteristics will be noted upon entry into the study: admitting diagnosis, demographics (age, sex), whether they have MNCD, and their music sophistication. Patients' music sophistication will be evaluated using the General Musical Sophistication Subscale (GMSS) which is embedded within the Goldsmiths Musical Sophistication Index (Gold-MSI). Furthermore, as the investigators will be including patients who use medications for sleep in our study, the investigators will note what type of medication(s) the participants are taking. Specifically, the investigators will categorize the medications in the following categories: benzodiazepines, antidepressants, antipsychotics, melatonin or other; and the investigators will note if the indication is specifically for sleep or not.

Exclusion Criteria:

* Patients who already listen to music or non-musical sounds as part of their sleep routine.
* Patients with medical instability which limits their ability to participate in the study (determined by the patient's treating physician).
* Patients who have a diagnosis of a sleep disorder including obstructive sleep apnea and REM sleep behaviour disorder.
* Patients who are unable to communicate in English or French.
* Patients with behavioural issues that limit their participation in the study; specifically, those that have agitation or hyperactivity that limits their compliance with the intervention as can be seen in cases of severe BPSD (Behavioural and Psychological Symptoms of Dementia) or hyperactive delirium.
* Patients with severe hearing impairment, specifically those for whom their hearing impairment affects their ability to communicate their consent for this study and to listen to music.

Primary outcomes:
measure: Sleep quality measured subjectively via the Insomnia Severity Index (ISI) questionnaire
timeFrame: 7 days
measure: Total sleep time measured objectively via sleep logs
timeFrame: 7 days
measure: Number of awakenings during the night measured objectively via sleep logs
timeFrame: 7 days
Secondary outcomes:
measure: Total sleep time assessed via smart watches
timeFrame: 7 days
measure: Sleep onset latency assessed via smart watches
timeFrame: 7 days
measure: Wake after sleep onset assessed via smart watches
timeFrame: 7 days
measure: Sleep efficiency assessed via smart watches
timeFrame: 7 days
measure: Mood assessed via visual analog mood scale
timeFrame: 7 days
measure: Pain level assessed via a visual analog pain scale
timeFrame: 7 days
measure: Medications used for sleep
timeFrame: 7 days
measure: Enjoyment of intervention
timeFrame: 7 days
measure: Protocol adherence
timeFrame: 7 days
measure: Noise level
timeFrame: 7 days
measure: Duration of stay in hospital
timeFrame: 7 days
measure: Number of participations as a feasibility measure
timeFrame: 6 months
measure: Number of refusals as a feasibility measure
timeFrame: 6 months
measure: Number of eligible participants as a feasibility measure
timeFrame: 6 months
measure: Number of exclusions as a feasibility measure
timeFrame: 6 months
measure: Availability of the data as a feasibility measure
timeFrame: 6 months
measure: Time needed to collect the data as a feasibility measure
timeFrame: 6 months
measure: Cost of the study as a feasibility measure
timeFrame: 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: St. Mary's Hospital Center
state: Quebec
Study officials:
affiliation: McGill University
name: Julia Chabot, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: