Recruiting

Music Interventions

Sponsor:

McGill University

Code:

NCT05398419

Conditions

Sleep Disturbance

Insomnia

Music Listening Intervention

Non-musical Sound Listening Intervention

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Music listening intervention

Non-musical sounds listening intervention

Study Details

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.

Conditions

Sleep Disturbance

Insomnia

Music Listening Intervention

Non-musical Sound Listening Intervention

Study ID

NCT05398419

Start date

Apr 19, 2022

Status verified date

May, 2022

Completion date

Oct, 2022

Anticipated

Primary completion date

Oct, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Music group

The participants will listen to music at bedtime and overnight for 7 consecutive nights. The music selected in our study will be pleasant instrumental slow tempo music in a major mode. It will also be low contrast (without periods of silence).

active comparator: Non-musical sounds group

The participants will listen to non-musical sounds at bedtime and overnight for 7 consecutive nights. The non-musical sounds will be low-contrast nature sounds such as waves or rain. The investigators plan to use non-musical sounds that align with the frequency range of the musical stimuli.

no intervention: Standard of care (Control)

The participants will have no change to their usual sleep routine on the Geriatric Assessment Unit.

Interventions

Music listening intervention

Participants will listen to the music at bedtime and overnight for 7 consecutive nights. The music will be administered via headphones (sleep headbands without a cord) that are connected via Bluetooth to an MP3 player.

Non-musical sounds listening intervention

Participants will listen to the non-musical sounds at bedtime and overnight for 7 consecutive nights. The non-musical sounds will be administered via headphones (sleep headbands without a cord) that are connected via Bluetooth to an MP3 player.

Primary outcome measure

  • Sleep quality measured subjectively via the Insomnia Severity Index (ISI) questionnaire [ Time Frame: 7 days ]
  • Total sleep time measured objectively via sleep logs [ Time Frame: 7 days ]
  • Number of awakenings during the night measured objectively via sleep logs [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Sophia Mondestin, MD

514-625-0616sophia.mondestin@mail.mcgill.ca

Julia Chabot, MD, MSc

514-345-3511julia.chabot@mcgill.ca

Locations

St. Mary's Hospital Center

Recruiting

Montréal, Quebec, Canada, H3T 1M5

Contacts

Sophia Mondestin, MD

514-625-0616sophia.mondestin@mail.mcgill.ca

Julia Chabot, MD, MSc

514-345-3511julia.chabot@mcgill.ca

Principal Investigator:

Julia Chabot, MD, MSc

More Information

Sponsor

McGill University

Last update posted

Jun 1, 2022

Last verified

May, 2022

Keywords

  • Sleep disturbance
  • Insomnia
  • Music
  • Non-musical sounds

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2022-06-01.