- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03533400
Effectiveness of Jamboxx Respiratory Therapy Device: Study 1
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Albany, New York, United States, 12208
- Albany Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Quadriplegic and other spinal cord injury outpatients will be included.
Exclusion Criteria:
- Individuals already adhering to a daily regimen of prescribed respiratory therapy routine will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Group 1
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.
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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
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EXPERIMENTAL: Group 2
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.
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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
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Reported Patient Dyspnea
Time Frame: reported 1x/ week for the duration of the 1 year study
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Change in patient reported measure of breathlessness during daily activities from baseline over the course of the 1 year study
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reported 1x/ week for the duration of the 1 year study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multidimensional Dyspnea Profile
Time Frame: reported 1x/ week for the duration of the 1 year study
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A measure of breathlessness after performing an activity
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reported 1x/ week for the duration of the 1 year study
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Dyspnea-12 Questionnaire
Time Frame: Months 0, 3, 6, 9, 12
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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.
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Months 0, 3, 6, 9, 12
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FEV1
Time Frame: Months 0, 3, 6, 9, 12
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measure of pulmonary function (Forced Expiratory Volume over 1 second) measured in liters
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Months 0, 3, 6, 9, 12
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FVC
Time Frame: Months 0, 3, 6, 9, 12
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measure of pulmonary function (Forced Vital Capacity) measured in liters
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Months 0, 3, 6, 9, 12
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PEF
Time Frame: Months 0, 3, 6, 9, 12
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measure of pulmonary function (Peak Expiratory Flow) measured in liters
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Months 0, 3, 6, 9, 12
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MEP
Time Frame: Months 0, 3, 6, 9, 12
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measure of pulmonary function (Maximum Expiratory Pressure) measured in centimeters of H2O
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Months 0, 3, 6, 9, 12
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MIP
Time Frame: Months 0, 3, 6, 9, 12
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measure of pulmonary function (maximum inspiratory pressure) measured in centimeters of H2O
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Months 0, 3, 6, 9, 12
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Device usability
Time Frame: Months 6, 12
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Measurement of enjoyment and engagement with the intervention via survey
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Months 6, 12
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Clinically relevant events
Time Frame: Months 0, 3, 6, 9, 12
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e.g.
patient being sent for a chest x-ray, being ordered chest physiotherapy or blood tests
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Months 0, 3, 6, 9, 12
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Patient Empowerment
Time Frame: Months 0, 3, 6, 9, 12
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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
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Months 0, 3, 6, 9, 12
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marilyn Fisher, MD, Albany Medical College
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jamboxx RT Device Study 1
- 4R42HL132735-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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