Decreasing Delirium Through Music in Critically Ill Older Adults (DDM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Anxiety; Intensive Care Unit Delirium; Intensive Care Acquired Cognitive Impairment
• Intervention / Treatment: Other: Slow Tempo Music; Other: Attention Control

Detailed Description

One million adults in the United States receive mechanical ventilation for acute respiratory failure in the intensive care units (ICUs) annually and up to 80% of them develop delirium during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia.

Recent research studies exploring pharmacological strategies to manage ICU delirium have not demonstrated efficacy; a limitation also acknowledged in the Society of Critical Care Medicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption guidelines. Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients, factors that could predispose to ICU delirium. Our team is now proposing to conduct a large randomized clinical trial called "Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Rawlings, BSN, RN; Phone Number: 317-274-9052; Email: rawlingl@regenstrief.org
• Study Contact Backup: Name: Austin Uebelhor, BS; Phone Number: 317-274-9310; Email: akuebelh@iupui.edu

Study Locations

• United States
  • Indiana
    • Avon, Indiana, United States, 46123
      • IU Health West Hospital
    • Indianapolis, Indiana, United States, 46202
      • Methodist Hospital
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Slow Tempo Music; 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; For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.
Sham Comparator: Attention Control; One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.	Other: Attention Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Subjects will be followed up to 28 days post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium Severity	Delirium severity will be assessed twice daily by trained research assistants using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU.	Subjects will be followed up to 28 days post randomization
Pain intensity	Pain will be assessed by trained research assistants utilizing the Critical Care Pain Observation Tool (CPOT), a valid and reliable instrument in critically ill patients with and without delirium.. Scale range 0-8, higher score indicates worse pain.	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
Anxiety	Anxiety intensity defined as a heightened state of apprehension, agitation, and arousal, will be measured four times daily before and after assigned intervention using a 100-mm Visual Analog Scale-Anxiety (VAS-A). Scale range 0-100, higher score indicates worse 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
Cognition	Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Auditory Verbal Learning Test [AVLT] will be administered using a phone-based format. Score ranges, sum of learning trials 0-75, 30-minute delay 0-15, a lower score indicates a worse outcome.	3 months post hospital discharge
Cognition	Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Wechsler Adult Intelligence Scale- III Digit Span test will be administered using a phone-based format. Score range 0-30, a lower score indicates a worse outcome.	3 months post hospital discharge
Cognition	Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Symbol Digit Modalities Test will be administered using a phone-based format. Score range 0-110, a lower score indicates a worse outcome.	3 months post hospital discharge
Cognition	Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Multilingual Aphasia Examination Controlled Oral Word Association test will be administered using a phone-based format. Score range 0-no max score, a lower score indicates a worse outcome.	3 months post hospital discharge
Depression	We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood. Scale range 0-27, higher score indicates worse depression.	3 months post hospital discharge
Anxiety	We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety. Scale range 0-21, higher score indicates worse anxiety.	3 months post hospital discharge

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Babar Khan, MD, MS, Indiana University; Principal Investigator: Linda Chlan, PhD, RN, Mayo Clinic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): December 15, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Cognition; Delirium; Music
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; TEMPO
• Other Study ID Numbers: 1906664366; 5R01AG067631-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No