Music group for Dyssomnias

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Mary's Hospital Center, Montréal, Canada
Dyssomnias+6 More
Music listening intervention - Other
Eligibility
65+
All Sexes
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Study 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.

Eligible Conditions

  • Dyssomnias
  • Music Listening Intervention
  • Insomnia
  • Sleep Disturbance
  • Non-musical Sound Listening Intervention

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 18 Secondary · Reporting Duration: 6 months

6 months
Availability of the data as a feasibility measure
Cost of the study as a feasibility measure
Number of eligible participants as a feasibility measure
Number of exclusions as a feasibility measure
Number of participations as a feasibility measure
Number of refusals as a feasibility measure
Time needed to collect the data as a feasibility measure
7 days
Duration of stay in hospital
Enjoyment of intervention
Medications used for sleep
Mood assessed via visual analog mood scale
Noise level
Number of awakenings during the night measured objectively via sleep logs
Pain level assessed via a visual analog pain scale
Protocol adherence
Sleep efficiency assessed via smart watches
Sleep onset latency assessed via smart watches
Sleep quality measured subjectively via the Insomnia Severity Index (ISI) questionnaire
Total sleep time assessed via smart watches
Total sleep time measured objectively via sleep logs
Wake after sleep onset assessed via smart watches

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Non-musical sounds group
1 of 3
Standard of care (Control)
1 of 3
Music group
1 of 3
Active Control
Experimental Treatment

50 Total Participants · 3 Treatment Groups

Primary Treatment: Music group · No Placebo Group · N/A

Music group
Other
Experimental Group · 1 Intervention: Music listening intervention · Intervention Types: Other
Non-musical sounds group
Other
ActiveComparator Group · 1 Intervention: Non-musical sounds listening intervention · Intervention Types: Other
Standard of care (Control)NoIntervention Group · 1 Intervention: Standard of care (Control) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Trial Background

Shek Fung, Principal Investigator
Principal Investigator
McGill University
Closest Location: St. Mary's Hospital Center · Montréal, Canada
2010First Recorded Clinical Trial
1 TrialsResearching Dyssomnias
21 CompletedClinical Trials

Eligibility Criteria

Age 65+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.