Music Interventions for the Facilitation of Sleep in the Acute Geriatric Setting

NCT05398419 | Unknown

• 1 other identifier: SMHC-21-21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Sleep disturbance; Insomnia; Music; Non-musical sounds

Outcome Measures

Primary Outcomes (3)

• Sleep quality measured subjectively via the Insomnia Severity Index (ISI) questionnaire

  Sleep quality will also be measured subjectively through patients' own perspectives of their sleep with the Insomnia Severity Index (ISI) questionnaire which will be administered to the patients daily. The ISI is a questionnaire which has seven questions that pertain to participants' severity of insomnia symptoms. Participants are asked to answer each question on a scale of 0 to 4 (0 being asymptomatic and 4 being very symptomatic). The seven answers are added up to get a total score which ranges between 0 and 28. The higher the score, the more severe the insomnia is. The ISI questions will be slightly modified so that the questions focus on patients' latest night of sleep, not on their sleep over the past 2 weeks, as this questionnaire will be administered daily. The ISI has been shown to be a reliable and valid tool as an outcome measure in insomnia treatment and research in older patients.

  7 days

• Total sleep time measured objectively via sleep logs

  Total sleep time will be measured objectively by sleep logs. This will be done by the overnight nurses who will complete a form in the morning where they will write down the following for each participant: * the time of sleep onset * the wake time in the morning * the number and duration of awakenings during the night (if there are any). The research assistants will pick up the form the next day to collect that data. With this information, the investigators will be able to calculate the total sleep time of each participant for each night in the study.

  7 days

• Number of awakenings during the night measured objectively via sleep logs

  The number of awakenings will be measured objectively by sleep logs. This will be done by the overnight nurses who will complete a form in the morning where they will write down the number and duration of awakenings during the night (if there are any) for each participant as noted above. The research assistants will pick up the form the next day to collect that data.

  7 days

Secondary Outcomes (18)

• Total sleep time assessed via smart watches

  7 days

• Sleep onset latency assessed via smart watches

  7 days

• Wake after sleep onset assessed via smart watches

  7 days

• Sleep efficiency assessed via smart watches

  7 days

• Mood assessed via visual analog mood scale

  7 days

Study Arms (3)

Music group

EXPERIMENTAL

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).

Other: Music listening intervention

Non-musical sounds group

ACTIVE COMPARATOR

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.

Other: Non-musical sounds listening intervention

Standard of care (Control)

NO INTERVENTION

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

Interventions

Music listening intervention OTHER

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.

Music group

Non-musical sounds listening intervention OTHER

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.

Non-musical sounds group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead
• St. Mary's Hospital Foundation: collaborator

Study Sites (1)

St. Mary's Hospital Center

Montreal, Quebec, H3T 1M5, Canada

RECRUITING

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Julia Chabot, MD, MSc

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Mondestin, MD

CONTACT

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

Julia Chabot, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: June 1, 2022
• Study Start: April 19, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

CA (1)