Decreasing Delirium Through Music in Critically Ill Older Adults

NCT04182334 | Completed Results DMC

• 2 other identifiers: 19066643665R01AG067631-03
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 5

Brief Summary

Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.

Conditions

Intensive Care Unit Delirium; Pain; Anxiety; Intensive Care Acquired Cognitive Impairment

Keywords

Delirium; Music; Pain; Anxiety; Cognition

Outcome Measures

Primary Outcomes (1)

• Days Free of Delirium and Coma

  Days free of delirium and coma will be the primary outcome for the trial. Days free of delirium and coma are the number of days after randomization patient is alive free of delirium and not in coma during the seven-day study intervention phase.

  Seven day study intervention phase

Secondary Outcomes (9)

• Delirium Severity

  Subjects will be followed up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.

• Pain Intensity

  4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.

• Anxiety

  4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.

• Cognition

  3 months post hospital discharge

• Cognition

  3 months post hospital discharge

Study Arms (2)

Slow Tempo Music

EXPERIMENTAL

Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.

Other: Slow Tempo Music

Attention Control

SHAM COMPARATOR

One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.

Other: Attention Control

Interventions

Slow Tempo Music OTHER

For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.

Slow Tempo Music

Attention Control OTHER

Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.

Attention Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years or older.
• English speaking.
• Admitted to the intensive care unit (medical or surgical).
• Expected mechanical ventilator support for ≥48 hours.
• Consentable through a legally authorized representative.
• Have access to a telephone.

You may not qualify if:

• History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.
• Psychiatric illness which is not well controlled.
• Alcohol withdrawal symptoms/concern for withdrawal.
• Suspected or confirmed drug intoxication/overdose
• Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
• Uncorrected hearing or vision impairment including legal blindness.
• Incarcerated at the time of study enrollment.
• Enrolled in another clinical trial which does not permit co-enrollment.
• Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (5)

IU Health West Hospital

Avon, Indiana, 46123, United States

Location

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Khan BA, Khan SH, Perkins AJ, Heiderscheit A, Unverzagt FW, Wang S, Downs JH 3rd, Gao S, Chlan LL. Slow-Tempo Music and Delirium/Coma-Free Days Among Older Adults Undergoing Mechanical Ventilation: A Randomized Clinical Trial. JAMA Intern Med. 2025 Dec 1;185(12):1442-1453. doi: 10.1001/jamainternmed.2025.5263.

  PMID: 41082215 DERIVED

• Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.

  PMID: 35854358 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Delirium

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders

Results Point of Contact

• Title: Babar Khan, MD, MS
• Organization: Indiana University

bakhan@iu.edu

(317) 274-9132

Study Officials

• Babar Khan, MD, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Linda Chlan, PhD, RN

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the unblinded study coordinator is aware of randomization. Outcomes assessors are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Slow Tempo Music vs Attention Control

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: March 5, 2020
• Primary Completion: December 15, 2023
• Study Completion: April 8, 2024
• Last Updated: September 22, 2025
• Results First Posted: January 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)