Acute Respiratory Distress SyndromeNCT03642002
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
A study testing Toning, Ocean drum & SOK melody and SOK in people with Acute Respiratory Distress Syndrome and Acute Hypoxemic Respiratory Failure, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial summary
While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure
- What is being tested?
- Toning, Ocean drum & SOK melody and SOK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Dec 2018to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
- Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study
Who cannot join
- Under 18 years of age
- Identified hearing disorder
- Prior history of chronic respiratory failure requiring mechanical ventilation
- RASS score of -4, or -5
- Active seizures, or status epilepticus
- Cardiac arrest
Show all 9Show fewer
- Coma
- End of life
- More than 2 vasopressors
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Jennifer Townsend, Master of Music Therapy, 713-441-9231, jdtownsend@houstonmethodist.org
Jennifer Townsend, Master of Music Therapy
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Jennifer Townsend, 713-441-9231, jdtownsend@houstonmethodist.org
Jennifer Townsend
- Recruiting
Mount Sinai West
New York, New York, 10019
Joanne Loewy, DA, LCAT, MT-BC, (212) 420-3484, joanne.loewy@mountsinai.org
Christopher Pizzute, MA, LCAT-LP, MT-BC, (212) 636-3112, Christopher.Pizzute2@mountsinai.org
About this study
While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.
Read the detailed description
The study will include 178 adult patients on mechanical ventilation. These patients will be randomly assigned to the music therapy group or control group and matched for diagnosis, co-morbidities, age, and gender. The music therapy group will utilize a certified music therapist to provide live music based on the patient's cultural preferences and entrainment. The primary outcome is a reduction in mechanical ventilation hours of 35% compared to the control group. Secondary outcomes include: Amount of sedation, Richmond Agitation-Sedation Scale (RASS), delirium and pain score, ICU and hospital length of stay. The researchers hypothesize that live entrained music therapy compared to control will result in a reduction in the time of extubation, amount of sedation administered, ICU and hospital length of stay.
- Conditions
- Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure
- Being tested
- Toning, Ocean drum & SOK melody, SOK, Process, Holding Harmonic Container
- Keywords
- music therapy, song of kin, music medicine
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToningOther
Music therapist will begin gentle breathing and toning on a descending "Ah" vowel to stimulate vibration in the chest and increase awareness of the breath. The patient will be encouraged to join the music therapist as is comfortable
Ocean drum & SOK melodyOther
Music therapist will introduce ocean drum to mimic breathing sounds and will hum the melody of Song of Kin to begin entrainment process. Patient will be invited to join the music therapist in humming as is comfortable
SOKOther
Music therapist will introduce sung lyric content of Song of Kin accompanied on guitar. Patient will be invited to sing with music therapist as is comfortable.
ProcessBehavioural
Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
Holding Harmonic ContainerOther
Music therapist will provide a holding harmonic container of IM7 - IVM7 and will improvise a repeating melody on "ah" based on the ambient sounds in the patient's immediate environment
| Study group | Role | What they receive |
|---|---|---|
| Toning | Experimental | Vocal Tonal Holding Receives: Other: Toning |
| Ocean drum & SOK melody | Other | Ocean drum followed by melody of song of kin Receives: Other: Ocean drum & SOK melody |
| SOK | Experimental | Song of kin with lyric content Receives: Other: SOK |
| Process | Experimental | Processing of experience Receives: Behavioral: Process |
| Holding Harmonic Container | Experimental | Not described Receives: Other: Holding Harmonic Container |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Length of Time on Ventilator
Measured: average 14 days
Secondary outcomes (11)
Cumulative Length of Stay in Hospital
Measured: average 14 days
Respiration Rate
Measured: 15 minute intervals over 30 minute intervention
Heart Rate
Measured: 15 minute intervals over 30 minute intervention
Oxygen Saturation
Measured: 15 minute intervals over 30 minute intervention
Amount of sedation
Measured: 14 days
Richmond Agitation-Sedation Scale (RASS)
RASS is scored from +4 (combative) to -5 (unarousable), with lower score indicating more sedation.
Measured: 14 days
State-Trait Anxiety Inventory (STAI) (Short Form)
To calculate the total STAI score (range 20-80):
- Reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2, and 4=1;
- Sum all six scores;
- Multiply total score by 20/6
- Scores are interpreted such that a "normal" score is approximately 24-36, Higher score indicates more anxiety
Measured: 14 days
Confusion Assessment Method for the ICU (CAM-ICU)
CAM-ICU is a delirium monitoring instrument for ICU patients, scored for two possibilities: CAM-ICU Positive (where delirium is present for a patient) or CAM-ICU Negative (where delirium is not present for a patient).
Measured: 14 days
Pain score
Numeric Pain Score (for enrollees able to speak). Pain score from 0 (no pain) to 10 (most pain)
Measured: 14 days
Wong-Baker FACES ® Pain Rating Scale
Wong-Baker FACES ® Pain Rating Scale (for enrollees unable to speak). Pain score from 0 (no pain) to 10 (most pain)
Measured: 14 days
ICU length of stay
Measured: average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start12 Dec 2018
- Primary completionApr 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Outcomes Assessor will be unfamiliar with desired outcomes
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Loewy, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanne Loewy, DA, LCAT, MT-BC, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642002
- Sponsor's protocol ID
- GCO 18-1079
- Status last verified
- Apr 2025
- First submitted
- 15 Aug 2018
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chlan LL. Psychophysiologic responses of mechanically ventilated patients to music: a pilot study. Am J Crit Care. 1995 May;4(3):233-8.
PubMed 7787918Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.
PubMed 26522499Chlan L. Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance. Heart Lung. 1998 May-Jun;27(3):169-76. doi: 10.1016/s0147-9563(98)90004-8.
PubMed 9622403Chlan LL. Music therapy as a nursing intervention for patients supported by mechanical ventilation. AACN Clin Issues. 2000 Feb;11(1):128-38. doi: 10.1097/00044067-200002000-00014.
PubMed 11040559Conti G, Mantz J, Longrois D, Tonner P. Sedation and weaning from mechanical ventilation: time for 'best practice' to catch up with new realities? Multidiscip Respir Med. 2014 Aug 29;9(1):45. doi: 10.1186/2049-6958-9-45. eCollection 2014.
PubMed 25473522Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.
PubMed 28786890Hetland B, Lindquist R, Weinert CR, Peden-McAlpine C, Savik K, Chlan L. Predictive Associations of Music, Anxiety, and Sedative Exposure on Mechanical Ventilation Weaning Trials. Am J Crit Care. 2017 May;26(3):210-220. doi: 10.4037/ajcc2017468.
PubMed 28461543Hunter BC, Oliva R, Sahler OJ, Gaisser D, Salipante DM, Arezina CH. Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation. J Music Ther. 2010 Fall;47(3):198-219. doi: 10.1093/jmt/47.3.198.
PubMed 21275332Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
PubMed 17085009Lee CH, Lee CY, Hsu MY, Lai CL, Sung YH, Lin CY, Lin LY. Effects of Music Intervention on State Anxiety and Physiological Indices in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit. Biol Res Nurs. 2017 Mar;19(2):137-144. doi: 10.1177/1099800416669601. Epub 2016 Sep 21.
PubMed 27655993Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
PubMed 23589814Loewy J, Hallan C, Friedman E, Martinez C. Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):343-55.
PubMed 17285817Lindgren VA, Ames NJ. Caring for patients on mechanical ventilation: what research indicates is best practice. Am J Nurs. 2005 May;105(5):50-60; quiz 61. doi: 10.1097/00000446-200505000-00029. No abstract available.
PubMed 15867534Zilberberg MD, Shorr AF. Prolonged acute mechanical ventilation and hospital bed utilization in 2020 in the United States: implications for budgets, plant and personnel planning. BMC Health Serv Res. 2008 Nov 25;8:242. doi: 10.1186/1472-6963-8-242.
PubMed 19032766Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
PubMed 24088092
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
- ClinicalTrials.gov ID
- NCT03642002
- Acronym / sponsor ID
- GCO 18-1079
- Conditions
- Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure, Acute Hypercapnic Respiratory Failure
- Keywords
- music therapy, song of kin, music medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.
Detailed description
The study will include 178 adult patients on mechanical ventilation. These patients will be randomly assigned to the music therapy group or control group and matched for diagnosis, co-morbidities, age, and gender. The music therapy group will utilize a certified music therapist to provide live music based on the patient's cultural preferences and entrainment. The primary outcome is a reduction in mechanical ventilation hours of 35% compared to the control group. Secondary outcomes include: Amount of sedation, Richmond Agitation-Sedation Scale (RASS), delirium and pain score, ICU and hospital length of stay. The researchers hypothesize that live entrained music therapy compared to control will result in a reduction in the time of extubation, amount of sedation administered, ICU and hospital length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Outcomes Assessor will be unfamiliar with desired outcomes
| Arm | Type | Receives |
|---|---|---|
| Toning | Experimental | Other: ToningVocal Tonal Holding |
| Ocean drum & SOK melody | Other | Other: Ocean drum & SOK melodyOcean drum followed by melody of song of kin |
| SOK | Experimental | Other: SOKSong of kin with lyric content |
| Process | Experimental | Behavioral: ProcessProcessing of experience |
| Holding Harmonic Container | Experimental | Other: Holding Harmonic Container |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
- Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study
Key exclusion criteria (9 listed)
- Under 18 years of age
- Identified hearing disorder
- Prior history of chronic respiratory failure requiring mechanical ventilation
- RASS score of -4, or -5
- Active seizures, or status epilepticus
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 |
|---|---|---|
| ToningMusic therapist will begin gentle breathing and toning on a descending "Ah" vowel to stimulate vibration in the chest and increase awareness of the breath. The patient will be encouraged to join the music therapist as is comfortable | Other | Toning |
| Ocean drum & SOK melodyMusic therapist will introduce ocean drum to mimic breathing sounds and will hum the melody of Song of Kin to begin entrainment process. Patient will be invited to join the music therapist in humming as is comfortable | Other | Ocean drum & SOK melody |
| SOKMusic therapist will introduce sung lyric content of Song of Kin accompanied on guitar. Patient will be invited to sing with music therapist as is comfortable. | Other | SOK |
| ProcessMusic therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath. | Behavioural | Process |
| Holding Harmonic ContainerMusic therapist will provide a holding harmonic container of IM7 - IVM7 and will improvise a repeating melody on "ah" based on the ambient sounds in the patient's immediate environment | Other | Holding Harmonic Container |
Primary outcome
Cumulative Length of Time on Ventilator
Time frame: average 14 days
11 secondary outcomes
Cumulative Length of Stay in Hospital
Time frame: average 14 days
Respiration Rate
Time frame: 15 minute intervals over 30 minute intervention
Heart Rate
Time frame: 15 minute intervals over 30 minute intervention
Oxygen Saturation
Time frame: 15 minute intervals over 30 minute intervention
Amount of sedation
Time frame: 14 days
Richmond Agitation-Sedation Scale (RASS)
Time frame: 14 days
State-Trait Anxiety Inventory (STAI) (Short Form)
Time frame: 14 days
Confusion Assessment Method for the ICU (CAM-ICU)
Time frame: 14 days
Pain score
Time frame: 14 days
Wong-Baker FACES ® Pain Rating Scale
Time frame: 14 days
ICU length of stay
Time frame: average 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 7787918Chlan LL. Psychophysiologic responses of mechanically ventilated patients to music: a pilot study. Am J Crit Care. 1995 May;4(3):233-8.
- Background: PubMed 26522499Canga B, Azoulay R, Raskin J, Loewy J. AIR: Advances in Respiration - Music therapy in the treatment of chronic pulmonary disease. Respir Med. 2015 Dec;109(12):1532-9. doi: 10.1016/j.rmed.2015.10.001. Epub 2015 Oct 19.
- Background: PubMed 9622403Chlan L. Effectiveness of a music therapy intervention on relaxation and anxiety for patients receiving ventilatory assistance. Heart Lung. 1998 May-Jun;27(3):169-76. doi: 10.1016/s0147-9563(98)90004-8.
- Background: PubMed 11040559Chlan LL. Music therapy as a nursing intervention for patients supported by mechanical ventilation. AACN Clin Issues. 2000 Feb;11(1):128-38. doi: 10.1097/00044067-200002000-00014.
- Background: PubMed 25473522Conti G, Mantz J, Longrois D, Tonner P. Sedation and weaning from mechanical ventilation: time for 'best practice' to catch up with new realities? Multidiscip Respir Med. 2014 Aug 29;9(1):45. doi: 10.1186/2049-6958-9-45. eCollection 2014.
- Background: PubMed 28786890Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.
- Background: PubMed 28461543Hetland B, Lindquist R, Weinert CR, Peden-McAlpine C, Savik K, Chlan L. Predictive Associations of Music, Anxiety, and Sedative Exposure on Mechanical Ventilation Weaning Trials. Am J Crit Care. 2017 May;26(3):210-220. doi: 10.4037/ajcc2017468.
- Background: PubMed 21275332Hunter BC, Oliva R, Sahler OJ, Gaisser D, Salipante DM, Arezina CH. Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation. J Music Ther. 2010 Fall;47(3):198-219. doi: 10.1093/jmt/47.3.198.
- Background: PubMed 17085009Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.
- Background: PubMed 27655993Lee CH, Lee CY, Hsu MY, Lai CL, Sung YH, Lin CY, Lin LY. Effects of Music Intervention on State Anxiety and Physiological Indices in Patients Undergoing Mechanical Ventilation in the Intensive Care Unit. Biol Res Nurs. 2017 Mar;19(2):137-144. doi: 10.1177/1099800416669601. Epub 2016 Sep 21.
- Background: PubMed 23589814Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
- Background: PubMed 17285817Loewy J, Hallan C, Friedman E, Martinez C. Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):343-55.
- 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.
Joanne Loewy, DA, LCAT, MT-BC principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toning, Ocean drum & SOK melody and SOK in people with Acute Respiratory Distress Syndrome and Acute Hypoxemic Respiratory Failure, run by Icahn School of Medicine at Mount Sinai at 3 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 2 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Loewy, DA, LCAT, MT-BC ((212) 420-3484, joanne.loewy@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Length of Time on Ventilator (time frame: average 14 days). 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 NCT03642002, which also lists 15 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 9 Apr 2025.