Clinical trial NCT04182334: Decreasing Delirium Through Music in Critically Ill Older Adults
Official title: Decreasing Delirium Through Music in Critically Ill Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Delirium
Pain
Anxiety
Intensive Care Acquired Cognitive Impairment
Keywords: Delirium
Music
Pain
Anxiety
Cognition
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-12-02
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Slow Tempo Music vs Attention Control
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Days Free of Delirium and Coma
timeFrame: Seven day study intervention phase
Secondary outcomes:
measure: Delirium Severity
timeFrame: Subjects will be followed up to 28 days post randomization
measure: Pain Intensity
timeFrame: 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
measure: Anxiety
timeFrame: 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
measure: Cognition
timeFrame: 3 months post hospital discharge
measure: Cognition
timeFrame: 3 months post hospital discharge
measure: Cognition
timeFrame: 3 months post hospital discharge
measure: Cognition
timeFrame: 3 months post hospital discharge
measure: Depression
timeFrame: 3 months post hospital discharge
measure: Anxiety
timeFrame: 3 months post hospital discharge
Other outcomes:
Locations:
city: Avon
country: United States
facility: IU Health West Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Indiana University
name: Babar Khan, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Linda Chlan, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.