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

Indiana University

Status: Completed

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

Treatments: Other: Slow Tempo Music; Other: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04182334

5R01AG067631-03 (U.S. NIH Grant/Contract)

1906664366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups

Slow Tempo Music

Experimental group

Description:

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.

Treatment:

Other: Slow Tempo Music

Attention Control

Sham Comparator group

Description:

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

Treatment:

Other: Attention Control