Intensive Care Unit DeliriumDDMNCT04182334
Decreasing Delirium Through Music in Critically Ill Older Adults
A study testing Slow Tempo Music in people with Intensive Care Unit Delirium and Pain, run by Indiana University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intensive Care Unit Delirium, Pain, Anxiety
- What is being tested?
- Slow Tempo Music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Mar 2020to 8 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years or older.
- English speaking.
- Admitted to the intensive care unit (medical or surgical).
- Expected mechanical ventilator support for ≥48 hours.
- Consentable through a legally authorized representative.
- Have access to a telephone.
Who cannot join
- History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.
- Psychiatric illness which is not well controlled.
- Alcohol withdrawal symptoms/concern for withdrawal.
- Suspected or confirmed drug intoxication/overdose
- Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
- Uncorrected hearing or vision impairment including legal blindness.
Show all 9Show fewer
- Incarcerated at the time of study enrollment.
- Enrolled in another clinical trial which does not permit co-enrollment.
- Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
IU Health West Hospital
Avon, Indiana, 46123
Eskenazi Hospital
Indianapolis, Indiana, 46202
IU Health University Hospital
Indianapolis, Indiana, 46202
Methodist Hospital
Indianapolis, Indiana, 46202
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Being tested
- Slow Tempo Music, Attention Control
- Keywords
- Delirium, Music, Pain, Anxiety, Cognition
- Medical subject headings
- Pain, Anxiety Disorders, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow Tempo MusicOther
For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.
Attention ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Slow Tempo Music |
| Attention Control | Sham comparator | One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven day study intervention phase
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start5 Mar 2020
- Primary completion15 Dec 2023
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit DeliriumStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Slow Tempo Music vs Attention Control
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Babar Khan, MD, MS, Indiana University
- Investigators
- Babar Khan, MD, MS, Principal investigator, Indiana UniversityLinda Chlan, PhD, RN, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182334
- Sponsor's protocol ID
- 1906664366
- Other IDs
- 5R01AG067631-03
- Acronym
- DDM
- Status last verified
- Sep 2025
- First submitted
- 25 Nov 2019
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41082215Seyffert 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.
PubMed 35854358
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Delirium Through Music in Critically Ill Older Adults
- ClinicalTrials.gov ID
- NCT04182334
- Acronym / sponsor ID
- DDM / 1906664366
- Keywords
- Delirium, Music, Pain, Anxiety, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Slow Tempo Music vs Attention Control
| Arm | Type | Receives |
|---|---|---|
| Slow Tempo Music | Experimental | Other: Slow Tempo MusicSlow-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 | Other: Attention ControlOne-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 years or older.
- English speaking.
- Admitted to the intensive care unit (medical or surgical).
- Expected mechanical ventilator support for ≥48 hours.
- Consentable through a legally authorized representative.
Key exclusion criteria (9 listed)
- History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.
- Psychiatric illness which is not well controlled.
- Alcohol withdrawal symptoms/concern for withdrawal.
- Suspected or confirmed drug intoxication/overdose
- Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow Tempo MusicFor up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones. | Other | Slow Tempo Music |
| Attention ControlSubjects 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. | Other | Attention Control |
Primary outcome
Days Free of Delirium and Coma
Time frame: 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.
9 secondary outcomes
Delirium Severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months post hospital discharge
Cognition
Time frame: 3 months post hospital discharge
Cognition
Time frame: 3 months post hospital discharge
Cognition
Time frame: 3 months post hospital discharge
Depression
Time frame: 3 months post hospital discharge
Anxiety
Time frame: 3 months post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41082215Khan 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.
- Derived from this study: PubMed 35854358Seyffert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babar Khan, MD, MS principal investigator
Indiana University
Linda Chlan, PhD, RN principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Tempo Music in people with Intensive Care Unit Delirium and Pain, run by Indiana University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days Free of Delirium and Coma (time frame: Seven day study intervention phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.