Trial Outcomes & Findings for Decreasing Delirium Through Music in Critically Ill Older Adults (NCT NCT04182334)

NCT ID: NCT04182334

Last Updated: 2025-09-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: Seven day study intervention phase
• Results posted on: 2025-09-22

Participant Flow

Per protocol subjects were considered to be enrolled in the study at the time of completion of the informed consent process. 160 subjects were enrolled. 159 subjects were randomized to one of the two study groups.

Participant milestones

Measure	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. 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.	Attention Control One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Overall Study STARTED	79	80
Overall Study COMPLETED	59	55
Overall Study NOT COMPLETED	20	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decreasing Delirium Through Music in Critically Ill Older Adults

Baseline characteristics by cohort

Measure	Slow Tempo Music n=79 Participants 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. 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.	Attention Control n=80 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.	Total n=159 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 9.1 • n=5 Participants	68.2 years STANDARD_DEVIATION 9.3 • n=7 Participants	67.9 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	63 Participants n=7 Participants	122 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Seven day study intervention phase

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.

Outcome measures

Measure	Slow Tempo Music n=79 Participants 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. 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.	Attention Control n=80 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Days Free of Delirium and Coma	2.5 Delirium/coma-free days by day 7 Interval 0.0 to 5.0	3 Delirium/coma-free days by day 7 Interval 0.0 to 5.0

SECONDARY outcome

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

Population: maximum number of participants analyzed during day 1 through day 7

Delirium severity was assessed twice daily by trained research assistants by the CAM-ICU-7, a seven point rating scale (0-7) where higher scores reflect higher delirium severity (worse outcomes). The CAM-ICU-7 score are categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. For the twice daily assessments, the mean of the two assessments was used.

Outcome measures

Measure	Slow Tempo Music n=68 Participants 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. 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.	Attention Control n=67 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Delirium Severity Day 5	2.78 score on a scale Standard Deviation 2.70	3.27 score on a scale Standard Deviation 2.83
Delirium Severity Day 1	5.43 score on a scale Standard Deviation 2.35	5.79 score on a scale Standard Deviation 2.16
Delirium Severity Day 2	4.77 score on a scale Standard Deviation 2.35	5.51 score on a scale Standard Deviation 2.18
Delirium Severity Day 3	4.10 score on a scale Standard Deviation 2.55	4.45 score on a scale Standard Deviation 2.61
Delirium Severity Day 4	3.54 score on a scale Standard Deviation 2.75	3.95 score on a scale Standard Deviation 2.72
Delirium Severity Day 6	2.73 score on a scale Standard Deviation 2.73	3.49 score on a scale Standard Deviation 2.94
Delirium Severity Day 7	2.72 score on a scale Standard Deviation 2.80	2.56 score on a scale Standard Deviation 2.72

SECONDARY outcome

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. The first 7 days were used for analysis per the protocol statistical plan.

Population: maximum number of participants analyzed during day 1 through day 7

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. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.

Outcome measures

Measure	Slow Tempo Music n=67 Participants 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. 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.	Attention Control n=66 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Pain Intensity Day 3	0.32 score on a scale Standard Deviation 0.82	0.21 score on a scale Standard Deviation 0.47
Pain Intensity Day 4	0.51 score on a scale Standard Deviation 0.87	0.31 score on a scale Standard Deviation 0.65
Pain Intensity Day 5	0.44 score on a scale Standard Deviation 0.91	0.31 score on a scale Standard Deviation 0.64
Pain Intensity Day 6	0.17 score on a scale Standard Deviation 0.48	0.25 score on a scale Standard Deviation 0.47
Pain Intensity Day 7	0.20 score on a scale Standard Deviation 0.55	0.61 score on a scale Standard Deviation 1.29
Pain Intensity Day 1	0.42 score on a scale Standard Deviation 0.94	0.30 score on a scale Standard Deviation 0.72
Pain Intensity Day 2	0.34 score on a scale Standard Deviation 0.85	0.34 score on a scale Standard Deviation 0.83

SECONDARY outcome

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. The first 7 days were used for analysis per the protocol statistical plan.

Population: maximum number of participants analyzed during day 1 through day 7

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. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.

Outcome measures

Measure	Slow Tempo Music n=25 Participants 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. 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.	Attention Control n=19 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Anxiety Day 1	40.56 score on a scale Standard Deviation 34.41	43.13 score on a scale Standard Deviation 33.77
Anxiety Day 2	38.40 score on a scale Standard Deviation 33.49	38.82 score on a scale Standard Deviation 34.81
Anxiety Day 3	39.38 score on a scale Standard Deviation 37.45	35.39 score on a scale Standard Deviation 38.28
Anxiety Day 4	37.86 score on a scale Standard Deviation 36.36	39.50 score on a scale Standard Deviation 33.31
Anxiety Day 5	25.72 score on a scale Standard Deviation 30.23	53.50 score on a scale Standard Deviation 38.97
Anxiety Day 6	34.36 score on a scale Standard Deviation 35.40	37.80 score on a scale Standard Deviation 44.57
Anxiety Day 7	43.63 score on a scale Standard Deviation 24.67	28.83 score on a scale Standard Deviation 38.40

SECONDARY outcome

Timeframe: 3 months post hospital discharge

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. During test administration there are 5 learning trials. After a 30-minute delay, the participants are asked to recall as many words as possible. The sum of learning trials are presented as scores ranging from 0-75, and for the 30-minute delay test scores range from 0-15. A lower score indicates a worse outcome.

Outcome measures

Measure	Slow Tempo Music n=13 Participants 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. 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.	Attention Control n=17 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Cognition AVTL Total Learning	32.23 score on a scale Standard Deviation 13.14	35.76 score on a scale Standard Deviation 12.10
Cognition AVTL Delayed Recall	5.3 score on a scale Standard Deviation 3.6	5.9 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 3 months post hospital discharge

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.

Outcome measures

Measure	Slow Tempo Music n=13 Participants 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. 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.	Attention Control n=17 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Cognition	15.85 score on a scale Standard Deviation 6.08	13.88 score on a scale Standard Deviation 4.48

SECONDARY outcome

Timeframe: 3 months post hospital discharge

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.

Outcome measures

Measure	Slow Tempo Music n=10 Participants 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. 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.	Attention Control n=15 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Cognition	35.10 score on a scale Standard Deviation 21.08	30.13 score on a scale Standard Deviation 12.44

SECONDARY outcome

Timeframe: 3 months post hospital discharge

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.

Outcome measures

Measure	Slow Tempo Music n=13 Participants 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. 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.	Attention Control n=15 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Cognition	32.31 score on a scale Standard Deviation 14.46	34.13 score on a scale Standard Deviation 10.22

SECONDARY outcome

Timeframe: 3 months post hospital discharge

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.

Outcome measures

Measure	Slow Tempo Music n=13 Participants 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. 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.	Attention Control n=16 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Depression	3.38 score on a scale Standard Deviation 3.62	7.50 score on a scale Standard Deviation 6.39

SECONDARY outcome

Timeframe: 3 months post hospital discharge

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.

Outcome measures

Measure	Slow Tempo Music n=13 Participants 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. 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.	Attention Control n=16 Participants One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Anxiety	2.46 score on a scale Standard Deviation 2.85	5.94 score on a scale Standard Deviation 6.49

Adverse Events

Slow Tempo Music

Serious events: 1 serious events

Other events: 2 other events

Deaths: 10 deaths

Attention Control

Serious events: 0 serious events

Other events: 2 other events

Deaths: 10 deaths

Serious adverse events

Measure	Slow Tempo Music n=79 participants at risk 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. 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.	Attention Control n=80 participants at risk One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Nervous system disorders Seizure	1.3% 1/79 • Number of events 1 • Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.	0.00% 0/80 • Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.

Other adverse events

Measure	Slow Tempo Music n=79 participants at risk 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. 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.	Attention Control n=80 participants at risk One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. 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.
Nervous system disorders Hallucination	1.3% 1/79 • Number of events 1 • Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.	0.00% 0/80 • Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.
Skin and subcutaneous tissue disorders Ear/ earlobe skin breakdown	1.3% 1/79 • Number of events 1 • Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.	2.5% 2/80 • Number of events 2 • Participants were assessed for adverse events from the time of informed consent process completion until the end of study participation. This was approximately 1 year if the study was completed.

Additional Information

Babar Khan, MD, MS

Indiana University

Phone: (317) 274-9132

Email: bakhan@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place