Spinal Cord InjuriesNCT03533400
Effectiveness of Jamboxx Respiratory Therapy Device: Study 1
A study testing Jamboxx Respiratory Therapy Device and Jamboxx Musical Device in people with Spinal Cord Injuries and Respiratory Complication, run by My Music Machines Inc. at 1 site in United States.
Trial summary
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Respiratory Complication
- What is being tested?
- Jamboxx Respiratory Therapy Device and Jamboxx Musical Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2019to 31 Dec 2019
- 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
- Quadriplegic and other spinal cord injury outpatients will be included.
Who cannot join
- Individuals already adhering to a daily regimen of prescribed respiratory therapy routine will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 1: Spinal Cord Injury Patients for Long Term Evaluation
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. The Jamboxx device combines gaming with traditional incentive spirometry to provide users with a fun experience to keep them engaged in their respiratory therapy routine. The device allows users to play a series of mini-games that walk them through their routines. The Jamboxx also records airflow and lung parameters with an external mouthpiece attachment to provide users with real time feedback, and helps to assess increases or decreases in relative lung function over time. The Jamboxx has the potential to significantly impact the field of respiratory therapy by being one of the first gaming devices for patient therapy, and the first respiratory therapy gaming device that is accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost alternative to the traditional therapy techniques used and aims to improve patient compliance.
Read the detailed description
Study 1 addresses the concerns of pneumonia risks in quadriplegics with compromised respiratory pump mechanics. In cases of spinal cord injury or high-level motor neuron disease, complications with respiratory function are a common concern. Lack of innervation to the intercostal and abdominal muscles can cause a decline in respiratory capacity as well as overall lung function, with associated increased risk of mortality. Shallow tidal breathing and impaired or absent cough results in morbidity and mortality from pneumonia. Several studies have found failure of the respiratory system, including pneumonia, to be a leading cause of mortality among spinal cord injury patients. In order to maintain pulmonary health, many people with quadriplegia and other high-level motor neuron diseases undergo routine respiratory therapy to help stretch the muscles around the lungs, exercise the diaphragm, and loosen mucus build-up. Incentive spirometry is one commonly used component of respiratory therapy designed to mimic natural sighing or yawning by encouraging the patient to take long, slow, deep breaths. This is done with an incentive spirometer device, which provides patients with visual or other positive feedback with a piston or a ball that moves inside a gauge. Respiratory therapy techniques are also used to help maintain pulmonary health in individuals with a number of chronic or temporary respiratory diseases and conditions such as asthma, chronic obstructive pulmonary disease, and emphysema. These techniques often become strenuous and mundane for users with limited mobility, and thus patient compliance rates are low. Gaming controlled by forceful respiratory maneuvers will be studied to ascertain if respiratory mechanics can be improved in this group.
Testing Plan: Study participants will be randomized into 2 groups through drawing of sealed envelopes. Group 1 (control group) will be given the standard Jamboxx musical device (see appendix a for device details), while Group 2 (treatment group) will be given the Jamboxx respiratory therapy device, which combines musical gameplay with incentive spirometry exercises. Participants from both groups will have two 20 minute training sessions with the device: one initial training visit and one follow up visit. Training sessions will take place either in the home, or at Albany Medical Center. During the initial visit a simple spirometry test (FEV1, FVC and PEF) and maximum inspiratory and expiratory pressures (MIP and MEP) will be performed. These functions will be measured again at 3, 6, 9 \& 12 months by a respiratory therapist (RT). The Dyspnea-12 (D-12) questionnaire will be conducted at by the RT at months 0, 3, 6, 9, and 12. Self-Reported Patient Dyspnea and the Multidimensional Dyspnea Profile (MDP) will be reported electronically by study participants on a weekly basis. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates. Access to medical records will be obtained by a signed medical release form.
- Conditions
- Spinal Cord Injuries, Respiratory Complication
- Being tested
- Jamboxx Respiratory Therapy Device, Jamboxx Musical Device
- Keywords
- respiratory therapy, videogaming therapy, incentive spirometry
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jamboxx Respiratory Therapy DeviceDevice
Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece containing a breath flow sensor that connects to a tablet. With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
Jamboxx Musical DeviceDevice
Jamboxx musical device is a hands free, breath controlled music device designed for people with quadriplegia. It resembles a common harmonica in that the user slides a mouthpiece along its horizontal axis to change the pitch of the instrument. The device connects to a personal computer via a mini USB to USB cable to interface with software that provides visual feedback for playing notes and sends the information to the computer speakers. The mouthpiece acts as a transducer, changing air pressure created by the user's lungs to a joystick signal to the computer via a differential pressure sensor. The Jamboxx musical device can produce musical sounds of many instruments (trumpet, drums, etc.) in many different scales and in any key
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 (control group) will be given the standard Jamboxx musical device. They will be trained to use the device during two 20 minute training session with a respiratory therapist, and will be instructed to play the device for a minimum of 30 minutes, 3 times a week. The Jamboxx musical device is a hands-free breath controlled musical device designed for people with quadriplegia. The mouthpiece acts as a transducer, changing air pressure created by the user's lungs to a joystick signal to the computer via a differential pressure sensor. The Jamboxx can produce musical sounds of many instruments (trumpet, drums, etc.) in many different scales and in any key. Receives: Device: Jamboxx Musical Device |
| Group 2 | Experimental | Group 2 (treatment group) will be given the Jamboxx musical device plus the Jamboxx respiratory therapy device. The respiratory therapy device is similar to the music device, but with specially designed games that guide the user through breathing exercises intended to strengthen the lungs. Receives: Device: Jamboxx Respiratory Therapy Device; Device: Jamboxx Musical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Reported Patient Dyspnea
Change in patient reported measure of breathlessness during daily activities from baseline over the course of the 1 year study
Measured: reported 1x/ week for the duration of the 1 year study
Secondary outcomes (10)
Multidimensional Dyspnea Profile
A measure of breathlessness after performing an activity
Measured: reported 1x/ week for the duration of the 1 year study
Dyspnea-12 Questionnaire
A survey that measures recent breathlessness with 12 questions related to dyspnea, each evaluated on a scale of 0-4 (0=none, 1=mild, 2=moderate, 3=severe) that indicate how troubled people are by each of these 12 topics, for a total possible score ranging from 0 to 36, where lower scores relate to better outcomes.
Measured: Months 0, 3, 6, 9, 12
FEV1
measure of pulmonary function (Forced Expiratory Volume over 1 second) measured in liters
Measured: Months 0, 3, 6, 9, 12
FVC
measure of pulmonary function (Forced Vital Capacity) measured in liters
Measured: Months 0, 3, 6, 9, 12
PEF
measure of pulmonary function (Peak Expiratory Flow) measured in liters
Measured: Months 0, 3, 6, 9, 12
MEP
measure of pulmonary function (Maximum Expiratory Pressure) measured in centimeters of H2O
Measured: Months 0, 3, 6, 9, 12
MIP
measure of pulmonary function (maximum inspiratory pressure) measured in centimeters of H2O
Measured: Months 0, 3, 6, 9, 12
Device usability
Measurement of enjoyment and engagement with the intervention via survey
Measured: Months 6, 12
Clinically relevant events
e.g. patient being sent for a chest x-ray, being ordered chest physiotherapy or blood tests
Measured: Months 0, 3, 6, 9, 12
Patient Empowerment
Measured via a single question ranked on a likert scale: "I believe that this respiratory therapy empowered me to protect my breathing" With answer options of 1. strongly disagree, 2. disagree, 3. neutral, 4. agree, 5. strongly agree, with higher numbers corresponding to better outcomes
Measured: Months 0, 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Dec 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: NHLBI has suggested the company focus on the other two ongoing trials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Study participants will be randomized into 2 groups via random number generator. Group 1 (control group) will be given the standard Jamboxx musical device, while Group 2 (treatment group) will be given the Jamboxx respiratory therapy device, which combines musical gameplay with incentive spirometry exercises.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- My Music Machines Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Albany Medical College, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marilyn Fisher, MD, Study chair, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533400
- Sponsor's protocol ID
- Jamboxx RT Device Study 1
- Other IDs
- 4R42HL132735-02
- Status last verified
- May 2020
- First submitted
- 26 Apr 2018
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 1: Spinal Cord Injury Patients for Long Term Evaluation
- ClinicalTrials.gov ID
- NCT03533400
- Acronym / sponsor ID
- Jamboxx RT Device Study 1
- Conditions
- Spinal Cord Injuries, Respiratory Complication
- Keywords
- respiratory therapy, videogaming therapy, incentive spirometry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NHLBI has suggested the company focus on the other two ongoing trials
- Enrolment
- 0 participants (actual)
- Lead sponsor
- My Music Machines Inc.Industry (pharma, biotech, devices)
- Collaborators
- Albany Medical College, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 May 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.
The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients with Decreased Respiratory Function is a proposal for investigation of the application of gaming to improving respiratory health. The Jamboxx device combines gaming with traditional incentive spirometry to provide users with a fun experience to keep them engaged in their respiratory therapy routine. The device allows users to play a series of mini-games that walk them through their routines. The Jamboxx also records airflow and lung parameters with an external mouthpiece attachment to provide users with real time feedback, and helps to assess increases or decreases in relative lung function over time. The Jamboxx has the potential to significantly impact the field of respiratory therapy by being one of the first gaming devices for patient therapy, and the first respiratory therapy gaming device that is accessible to users with limited mobility. Jamboxx provides a fun and engaging, low cost alternative to the traditional therapy techniques used and aims to improve patient compliance.
Detailed description
Study 1 addresses the concerns of pneumonia risks in quadriplegics with compromised respiratory pump mechanics. In cases of spinal cord injury or high-level motor neuron disease, complications with respiratory function are a common concern. Lack of innervation to the intercostal and abdominal muscles can cause a decline in respiratory capacity as well as overall lung function, with associated increased risk of mortality. Shallow tidal breathing and impaired or absent cough results in morbidity and mortality from pneumonia. Several studies have found failure of the respiratory system, including pneumonia, to be a leading cause of mortality among spinal cord injury patients. In order to maintain pulmonary health, many people with quadriplegia and other high-level motor neuron diseases undergo routine respiratory therapy to help stretch the muscles around the lungs, exercise the diaphragm, and loosen mucus build-up. Incentive spirometry is one commonly used component of respiratory therapy designed to mimic natural sighing or yawning by encouraging the patient to take long, slow, deep breaths. This is done with an incentive spirometer device, which provides patients with visual or other positive feedback with a piston or a ball that moves inside a gauge. Respiratory therapy techniques are also used to help maintain pulmonary health in individuals with a number of chronic or temporary respiratory diseases and conditions such as asthma, chronic obstructive pulmonary disease, and emphysema. These techniques often become strenuous and mundane for users with limited mobility, and thus patient compliance rates are low. Gaming controlled by forceful respiratory maneuvers will be studied to ascertain if respiratory mechanics can be improved in this group.
Testing Plan: Study participants will be randomized into 2 groups through drawing of sealed envelopes. Group 1 (control group) will be given the standard Jamboxx musical device (see appendix a for device details), while Group 2 (treatment group) will be given the Jamboxx respiratory therapy device, which combines musical gameplay with incentive spirometry exercises. Participants from both groups will have two 20 minute training sessions with the device: one initial training visit and one follow up visit. Training sessions will take place either in the home, or at Albany Medical Center. During the initial visit a simple spirometry test (FEV1, FVC and PEF) and maximum inspiratory and expiratory pressures (MIP and MEP) will be performed. These functions will be measured again at 3, 6, 9 \& 12 months by a respiratory therapist (RT). The Dyspnea-12 (D-12) questionnaire will be conducted at by the RT at months 0, 3, 6, 9, and 12. Self-Reported Patient Dyspnea and the Multidimensional Dyspnea Profile (MDP) will be reported electronically by study participants on a weekly basis. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates. Access to medical records will be obtained by a signed medical release form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be randomized into 2 groups via random number generator. Group 1 (control group) will be given the standard Jamboxx musical device, while Group 2 (treatment group) will be given the Jamboxx respiratory therapy device, which combines musical gameplay with incentive spirometry exercises.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Jamboxx Musical DeviceGroup 1 (control group) will be given the standard Jamboxx musical device. They will be trained to use the device during two 20 minute training session with a respiratory therapist, and will be instructed to play the device for a minimum of 30 minutes, 3 times a week. The Jamboxx musical device is a hands-free breath controlled musical device designed for people with quadriplegia. The mouthpiece acts as a transducer, changing air pressure created by the user's lungs to a joystick signal to the computer via a differential pressure sensor. The Jamboxx can produce musical sounds of many instruments (trumpet, drums, etc.) in many different scales and in any key. |
| Group 2 | Experimental | Device: Jamboxx Respiratory Therapy Device, Device: Jamboxx Musical DeviceGroup 2 (treatment group) will be given the Jamboxx musical device plus the Jamboxx respiratory therapy device. The respiratory therapy device is similar to the music device, but with specially designed games that guide the user through breathing exercises intended to strengthen the lungs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Quadriplegic and other spinal cord injury outpatients will be included.
Key exclusion criteria (1 listed)
- Individuals already adhering to a daily regimen of prescribed respiratory therapy routine will be excluded.
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 |
|---|---|---|
| Jamboxx Respiratory Therapy DeviceJamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece containing a breath flow sensor that connects to a tablet. With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking. | Device | Group 2 |
| Jamboxx Musical DeviceJamboxx musical device is a hands free, breath controlled music device designed for people with quadriplegia. It resembles a common harmonica in that the user slides a mouthpiece along its horizontal axis to change the pitch of the instrument. The device connects to a personal computer via a mini USB to USB cable to interface with software that provides visual feedback for playing notes and sends the information to the computer speakers. The mouthpiece acts as a transducer, changing air pressure created by the user's lungs to a joystick signal to the computer via a differential pressure sensor. The Jamboxx musical device can produce musical sounds of many instruments (trumpet, drums, etc.) in many different scales and in any key | Device | Group 1, Group 2 |
Primary outcome
Change in Self-Reported Patient Dyspnea
Time frame: reported 1x/ week for the duration of the 1 year study
Change in patient reported measure of breathlessness during daily activities from baseline over the course of the 1 year study
10 secondary outcomes
Multidimensional Dyspnea Profile
Time frame: reported 1x/ week for the duration of the 1 year study
Dyspnea-12 Questionnaire
Time frame: Months 0, 3, 6, 9, 12
FEV1
Time frame: Months 0, 3, 6, 9, 12
FVC
Time frame: Months 0, 3, 6, 9, 12
PEF
Time frame: Months 0, 3, 6, 9, 12
MEP
Time frame: Months 0, 3, 6, 9, 12
MIP
Time frame: Months 0, 3, 6, 9, 12
Device usability
Time frame: Months 6, 12
Clinically relevant events
Time frame: Months 0, 3, 6, 9, 12
Patient Empowerment
Time frame: Months 0, 3, 6, 9, 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- 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.
Marilyn Fisher, MD study chair
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jamboxx Respiratory Therapy Device and Jamboxx Musical Device in people with Spinal Cord Injuries and Respiratory Complication, run by My Music Machines Inc. at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Self-Reported Patient Dyspnea (time frame: reported 1x/ week for the duration of the 1 year study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2020.