Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182334
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Babar Khan, MD, MS, Indiana University

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.

Condition or disease Intervention/treatment Phase
Intensive Care Unit Delirium Pain Anxiety Intensive Care Acquired Cognitive Impairment Other: Slow Tempo Music Other: Attention Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Slow Tempo Music vs Attention Control
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Only the unblinded study coordinator is aware of randomization. Outcomes assessors are blinded
Primary Purpose: Treatment
Official Title: Decreasing Delirium Through Music in Critically Ill Older Adults
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma Delirium
Drug Information available for: Gelusil

Arm Intervention/treatment
Experimental: 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.
Other: 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.

Sham Comparator: Attention Control
One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.
Other: 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.




Primary Outcome Measures :
  1. Days free of delirium and coma [ Time Frame: Subjects will be followed up to 28 days post randomization ]
    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.


Secondary Outcome Measures :
  1. Delirium Severity [ Time Frame: Subjects will be followed up to 28 days post randomization ]
    Delirium severity will be assessed twice daily by trained research assistants using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU.


Other Outcome Measures:
  1. 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 ]
    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.

  2. 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 ]
    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).

  3. Cognition [ Time Frame: 3 months post intervention ]
    Cognition will be measured by 4 objective tests of memory, attention, information processing speed, and executive cognitive function (Auditory Verbal Learning Test [AVLT], Digit Span, and Symbol Digit Modalities Test [SDMT], and Controlled Oral Word Association test [COWA]) using a telephone-based administration format, the Indiana University Telephone-Based Assessment of Neuropsychological Status (IU- TBANS) at 3-months post hospital discharge.

  4. Depression [ Time Frame: 3 months post intervention ]
    We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood.

  5. Anxiety [ Time Frame: 3 months post intervention ]
    We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04182334


Contacts
Layout table for location contacts
Contact: Lori Rawlings, BSN, RN 317-274-9052 rawlingl@regenstrief.org
Contact: Austin Uebelhor, BS 317-274-9310 akuebelh@iupui.edu

Locations
Layout table for location information
United States, Indiana
Eskenazi Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Babar Khan, MD, MS         
Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Babar Khan, MD, MS         
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Babar Khan, MD, MS Indiana University
Principal Investigator: Linda Chlan, PhD, RN Mayo Clinic
Layout table for additonal information
Responsible Party: Babar Khan, MD, MS, Associate Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04182334    
Other Study ID Numbers: 1906664366
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Babar Khan, MD, MS, Indiana University:
Delirium
Music
Pain
Anxiety
Cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Delirium
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
TEMPO
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs