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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG067631-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Attention Control | Sham Comparator | One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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. | Seven day study intervention phase |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium Severity | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Babar Khan, MD, MS | Indiana University | Principal Investigator |
| Linda Chlan, PhD, RN | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health West Hospital | Avon | Indiana | 46123 | United States | ||
| Eskenazi Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41082215 | Derived | 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. | |
| 35854358 | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
160 subjects were enrolled, 159 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | Delirium/coma-free days by day 7 | Seven day study intervention phase |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hallucination | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Babar Khan, MD, MS | Indiana University | (317) 274-9132 | bakhan@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2023 | Dec 10, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2023 | Dec 10, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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Slow Tempo Music vs Attention Control
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Only the unblinded study coordinator is aware of randomization. Outcomes assessors are blinded
| 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. |
|
| 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 | 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. | 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 | 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. | 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 | 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. | 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 |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| IU Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. |
|
|
|
| Secondary | Delirium Severity | 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. | maximum number of participants analyzed during day 1 through day 7 | Posted | Mean | Standard Deviation | score on a scale | Subjects will be followed up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan. |
|
|
|
|
| Secondary | 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. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used. | maximum number of participants analyzed during day 1 through day 7 | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
|
| Secondary | 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. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used. | maximum number of participants analyzed during day 1 through day 7 | Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
|
| Secondary | 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. 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post hospital discharge |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post hospital discharge |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post hospital discharge |
|
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post hospital discharge |
|
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post hospital discharge |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post hospital discharge |
|
|
|
|
| 10 |
| 79 |
| 1 |
| 79 |
| 2 |
| 79 |
| EG001 | 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. | 10 | 80 | 0 | 80 | 2 | 80 |
| Ear/ earlobe skin breakdown | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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