Post Covid-19 RespiratoryNCT05231512
The Effects of a Music Therapy Respiratory Protocol on Post-Covid-19 Respiratory Symptoms
A study testing Respiratory Music Therapy Protocol in people with Post Covid-19 Respiratory and Dyspnea, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The effects of a tested and published music therapy respiratory protocol shown to be efficacious with pediatric asthma and adult COPD is being studied with individuals living with post-Covid-19 respiratory symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Covid-19 Respiratory, Dyspnea, SARS-CoV 2
- What is being tested?
- Respiratory Music Therapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2022to 13 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Participation in Mount Sinai Post-COVID Treatment Center care
- Confirmed or presumptive COVID-19 history based on symptoms
- Experiencing residual pulmonary issues (shortness of breath, fatigue)
- MRC Dyspnea score of grade 3, 4, or 5
- 18 years or older
Who cannot join
- Under 18 years
- MRC Dyspnea Score of grade 1 or 2
- Presence of respiratory issues without confirmed or presumptive COVID-19 diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Louis Armstrong Dept. of Music & Medicine, Mount Sinai Union Square
New York, New York, 10003
NYC Health & Hospitals - Elmhurst
New York, New York, 11373
About this study
Official title: The Effects of a Music Therapy Respiratory Protocol on Post-Covid Respiratory Symptoms
The effects of a tested and published music therapy respiratory protocol shown to be efficacious with pediatric asthma and adult COPD is being studied with individuals living with post-Covid-19 respiratory symptoms. An interventional, single arm study is being conducted with individuals meeting eligibility criteria detailed below. Primary outcome is a change in the MRC Dyspnea score, with secondary aims focusing on improved quality of life, including reduced fatigue and depression and improved sleep and resilience.
Read the detailed description
Since November 2019, the SARS-CoV-2 (COVID-19) virus has rapidly spread to countries across the globe. The COVID-19 pandemic is particularly destructive in the U.S., where, as of August 2020, total case numbers exceed 4 million. Recovering patients of COVID-19 report symptoms of fatigue, dyspnea (shortness of breath) and other pulmonary dysfunctions. A study conducted in Italy, where cases spiked to around 40,000 in March, showed that 87.4% of participants with post-acute COVID-19 experience at least one persistent symptom. Pulmonologists facing the pressing challenge of creating a respiratory rehabilitation program for recovering COVID-19 patients can benefit from integrating music therapy into their practice. Music therapy is the use of music, vocal or instrumental, to therapeutically address the holistic needs of a patient. Several studies have been conducted in the past investigating the neurological and physiological benefits of music therapy for patients engaging in breath regulation, and with pulmonary dysfunction such as COPD or asthma. At Mount Sinai Beth Israel, the Louis Armstrong Department of Music Therapy provides the Music for AIR (Advances in Respiration) programs to treat patients with lung disease, especially those with COPD. Music for AIR has successfully used wind instrument playing, singing, and music visualization to ease common symptoms of COPD including dyspnea and fatigue. As dyspnea and fatigue are also common persisting symptoms of patients recovering from COVID-19, Music for AIR interventions and its possible therapeutic benefits for recovering COVID-19 patients warrant a necessary investigation. Currently, there is no research looking specifically at music therapy as a modality of treatment for physical symptoms in post-COVID-19 patients. Thus, the aim of this study is to utilized previously validated interventions to measure efficacy in this unique population.COVID-19 affects multiple organs and systems. Current evidence shows that effects of the virus have surpassed the acute phase, manifesting in residual symptoms in neurological, physical, cognitive, pulmonary, and emotional areas. Music therapy is a clinical therapy that has demonstrated efficacy in improving function in these aforementioned areas. The purpose of this study is to examine clinical music therapy - specifically including wind playing, singing, and music visualizations - to study the effects on physical function and quality of life for adults experiencing shortness of breath who have been previously diagnosed with (or presumptive) COVID-19. This study aims to test a previously studied music therapy protocol on patients presenting with continued respiratory symptoms following confirmed or presumed COVID-19 diagnosis over an 8-week period within a virtual group setting. Secondary aims to be monitored are any changes in depression, anxiety, fatigue, sleep, quality of life, and resilience.
- Conditions
- Post Covid-19 Respiratory, Dyspnea, SARS-CoV 2
- Being tested
- Respiratory Music Therapy Protocol
- Keywords
- Post-Covid-19, respiratory, pulmonary, music, therapy, music therapy
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Music Therapy ProtocolOther
Also called Music therapy
Participants will engage in eight (8) 45-minute virtual music therapy groups containing up to 6 participants over the course of 8 weeks. Within these groups, participants will be invited to use instruments provided including a Yamaha recorder and a Grover Trophy slide whistle. 45 minute virtual music therapy sessions facilitated by board-certified music therapy will consist of music-assisted relaxation through music visualization, followed by gentle pulmonary exercise via wind instrumental playing, and concluding with group singing.
| Study group | Role | What they receive |
|---|---|---|
| Individuals living with post-Covid-19 respiratory symptoms | Experimental | Live virtual music therapy interventions for people experiencing difficulties breathing after having had COVID-19 (diagnosed or presumed). Receives: Other: Respiratory Music Therapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRC dyspnea score
MRC Dyspnea Score -Total scale from 1-5, with higher score indicating more perceived breathlessness.
Measured: 12 weeks
Secondary outcomes (10)
Self-reported Chronic Respiratory Questionnaire (CRQ-SR)
20 item questionnaire, each item score from 1 to 7. Total range from 20-140, with higher score indicating better health outcomes.
Measured: 12 weeks
Visual Analog Scale (VAS)
VAS full range from 0-10, with higher score indicating more fatigue
Measured: 12 weeks
Beck Depression Inventory - short form (BDI-SF)
13 items, full range from 0-39, with higher score indicating more severe symptoms of depression.
Measured: 12 weeks
General Anxiety Disorder 7-item questionnaire (GAD-7)
The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). Full scale from 0-21, with higher score indicating more symptoms.
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, scores for each subscale from 0 (normal) to 21 (severe symptoms) with full range from 0 to 42. Higher score indicating more distress.
Measured: 12 weeks
Coronavirus Anxiety Scale (CAS)
5-item scale, each item scored 0 (not at all) to 4 (nearly every day over the last 2 weeks). Full scale from 0-20, with higher score indicating poorer health outcomes.
Measured: 12 weeks
Fatigue Severity Scale
9 item scale, each item scored from 1 (strongly disagree) to 7 (strongly agree). Total scale from 9-63, with higher score indicating greater fatigue.
Measured: 12 weeks
The Epworth Sleepiness Scale (ESS
An 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities. Each item is scored from 0, no chance of dozing, to 3, high chance of dozing. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.
Measured: 12 weeks
EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
The EQ-5D is a generic instrument for describing and valuing health. The new version includes the 5 levels of severity in each of the existing five EQ-5D dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and now called the EQ-5D-5L. Full scale from 5 to 25, with higher score indicating poorer health outcomes.
Measured: 12 weeks
Connor-davidson Resilience Scale (CD-RISC)
Self-report 25-item scale, each item score from 0 (not true at all) to 4 (true nearly all the time). Full scale from 0-100, with higher score indicating better health outcomes.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start13 Jan 2022
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Covid-19 RespiratoryStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
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 V Loewy, DA, Principal investigator, Director Louis Armstrong Center for Music & Medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231512
- Sponsor's protocol ID
- STUDY 20-02110
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is specific to this study only
Publications
Loewy J, Goldsmith C, Deshpande S, Sun A, Harris J, van Es C, Zvi ZB, Dahmer S. Music therapy in pediatric asthma improves pulmonary function while reducing hospitalizations. J Asthma. 2021 May;58(5):674-682. doi: 10.1080/02770903.2020.1712725. Epub 2020 Jan 23.
PubMed 31906748Canga 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 26522499
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Music Therapy Respiratory Protocol on Post-Covid Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT05231512
- Acronym / sponsor ID
- STUDY 20-02110
- Conditions
- Post Covid-19 Respiratory, Dyspnea, SARS-CoV 2
- Keywords
- Post-Covid-19, respiratory, pulmonary, music, therapy, music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 9 Feb 2022 (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.
The effects of a tested and published music therapy respiratory protocol shown to be efficacious with pediatric asthma and adult COPD is being studied with individuals living with post-Covid-19 respiratory symptoms. An interventional, single arm study is being conducted with individuals meeting eligibility criteria detailed below. Primary outcome is a change in the MRC Dyspnea score, with secondary aims focusing on improved quality of life, including reduced fatigue and depression and improved sleep and resilience.
Detailed description
Since November 2019, the SARS-CoV-2 (COVID-19) virus has rapidly spread to countries across the globe. The COVID-19 pandemic is particularly destructive in the U.S., where, as of August 2020, total case numbers exceed 4 million. Recovering patients of COVID-19 report symptoms of fatigue, dyspnea (shortness of breath) and other pulmonary dysfunctions. A study conducted in Italy, where cases spiked to around 40,000 in March, showed that 87.4% of participants with post-acute COVID-19 experience at least one persistent symptom. Pulmonologists facing the pressing challenge of creating a respiratory rehabilitation program for recovering COVID-19 patients can benefit from integrating music therapy into their practice. Music therapy is the use of music, vocal or instrumental, to therapeutically address the holistic needs of a patient. Several studies have been conducted in the past investigating the neurological and physiological benefits of music therapy for patients engaging in breath regulation, and with pulmonary dysfunction such as COPD or asthma. At Mount Sinai Beth Israel, the Louis Armstrong Department of Music Therapy provides the Music for AIR (Advances in Respiration) programs to treat patients with lung disease, especially those with COPD. Music for AIR has successfully used wind instrument playing, singing, and music visualization to ease common symptoms of COPD including dyspnea and fatigue. As dyspnea and fatigue are also common persisting symptoms of patients recovering from COVID-19, Music for AIR interventions and its possible therapeutic benefits for recovering COVID-19 patients warrant a necessary investigation. Currently, there is no research looking specifically at music therapy as a modality of treatment for physical symptoms in post-COVID-19 patients. Thus, the aim of this study is to utilized previously validated interventions to measure efficacy in this unique population.COVID-19 affects multiple organs and systems. Current evidence shows that effects of the virus have surpassed the acute phase, manifesting in residual symptoms in neurological, physical, cognitive, pulmonary, and emotional areas. Music therapy is a clinical therapy that has demonstrated efficacy in improving function in these aforementioned areas. The purpose of this study is to examine clinical music therapy - specifically including wind playing, singing, and music visualizations - to study the effects on physical function and quality of life for adults experiencing shortness of breath who have been previously diagnosed with (or presumptive) COVID-19. This study aims to test a previously studied music therapy protocol on patients presenting with continued respiratory symptoms following confirmed or presumed COVID-19 diagnosis over an 8-week period within a virtual group setting. Secondary aims to be monitored are any changes in depression, anxiety, fatigue, sleep, quality of life, and resilience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals living with post-Covid-19 respiratory symptoms | Experimental | Other: Respiratory Music Therapy ProtocolLive virtual music therapy interventions for people experiencing difficulties breathing after having had COVID-19 (diagnosed or presumed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participation in Mount Sinai Post-COVID Treatment Center care
- Confirmed or presumptive COVID-19 history based on symptoms
- Experiencing residual pulmonary issues (shortness of breath, fatigue)
- MRC Dyspnea score of grade 3, 4, or 5
- 18 years or older
Key exclusion criteria (3 listed)
- Under 18 years
- MRC Dyspnea Score of grade 1 or 2
- Presence of respiratory issues without confirmed or presumptive COVID-19 diagnosis
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 |
|---|---|---|
| Respiratory Music Therapy ProtocolAlso: Music therapyParticipants will engage in eight (8) 45-minute virtual music therapy groups containing up to 6 participants over the course of 8 weeks. Within these groups, participants will be invited to use instruments provided including a Yamaha recorder and a Grover Trophy slide whistle. 45 minute virtual music therapy sessions facilitated by board-certified music therapy will consist of music-assisted relaxation through music visualization, followed by gentle pulmonary exercise via wind instrumental playing, and concluding with group singing. | Other | Individuals living with post-Covid-19 respiratory symptoms |
Primary outcome
MRC dyspnea score
Time frame: 12 weeks
MRC Dyspnea Score -Total scale from 1-5, with higher score indicating more perceived breathlessness.
10 secondary outcomes
Self-reported Chronic Respiratory Questionnaire (CRQ-SR)
Time frame: 12 weeks
Visual Analog Scale (VAS)
Time frame: 12 weeks
Beck Depression Inventory - short form (BDI-SF)
Time frame: 12 weeks
General Anxiety Disorder 7-item questionnaire (GAD-7)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Coronavirus Anxiety Scale (CAS)
Time frame: 12 weeks
Fatigue Severity Scale
Time frame: 12 weeks
The Epworth Sleepiness Scale (ESS
Time frame: 12 weeks
EuroQoL 5 dimensions 5 levels (EQ-5D-5L)
Time frame: 12 weeks
Connor-davidson Resilience Scale (CD-RISC)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 31906748Loewy J, Goldsmith C, Deshpande S, Sun A, Harris J, van Es C, Zvi ZB, Dahmer S. Music therapy in pediatric asthma improves pulmonary function while reducing hospitalizations. J Asthma. 2021 May;58(5):674-682. doi: 10.1080/02770903.2020.1712725. Epub 2020 Jan 23.
- 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.
- Individual participant dataSharing planned: No. The data is specific to this study only
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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.
Joanne V Loewy, DA principal investigator
Director Louis Armstrong Center for Music & Medicine,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Music Therapy Protocol in people with Post Covid-19 Respiratory and Dyspnea, run by Icahn School of Medicine at Mount Sinai at 2 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 5 inclusion and 3 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 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRC dyspnea score (time frame: 12 weeks). 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 NCT05231512, 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 14 Feb 2024.