Cystic Fibrosis in ChildrenNCT03522480
The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2
A study testing Jamboxx Respiratory Therapy Device and Autogenic Draining Training in people with Cystic Fibrosis in Children, 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 5 to 17 years
- Conditions the study is for
- Cystic Fibrosis in Children
- What is being tested?
- Jamboxx Respiratory Therapy Device and Autogenic Draining Training
- 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
- 30 Jan 2019to 31 Aug 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with CF requiring chest physiotherapy ages 5-17
Who cannot join
- Children with lung function of <25% FEV, hypercapnia, or requiring supplemental oxygen 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 2: Children With Cystic Fibrosis 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.
This study addresses the ongoing challenge of clearing the burden of bronchial secretions resulting from cystic fibrosis. These patients are dependent upon mechanical devices to help clear secretions. A device autonomous means for clearing secretions is well defined in the literature (autogenic drainage) but is difficult to learn. This study proposes to teach cystic fibrosis patients to master autogenic drainage, and seeks to determine at what age it can be taught. As it would be expected that gaming could easily teach adults this procedure, the study will include children for whom learning autogenic drainage based upon conceptualization would be expected to be very difficult.
Read the detailed description
Testing Plan: Children will be randomized into one of two groups via a random number generation software program
Group A (education \& gaming): Children will participate in 1 initial training session at Albany Med where they will be taught by a respiratory therapist (RT) to use autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to practice the autogenic draining technique 15 minutes three times per week. At week 8 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy. At the 8 week visit, the Jamboxx gaming device will be introduced through a training session with a RT, which will contain a game to guide them through the proper sequence of breathing for the autogenic draining technique. Patients will be sent home with a Jamboxx device and requested to do 15 minutes of autogenic drainage training three times a week. Patients will return for a research visits at week 16 and again will be tested via software program for ability to perform the autogenic drainage technique.
Group B (gaming only): Children will participate in an initial training session at Albany Med where they will be taught by a RT to use Jamboxx respiratory thearpy device to guide them through autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week. At week 8 and week 16 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy.
This protocol does not replace prescribed chest physiotherapy. There is no alteration of the standard of care beyond 15 minutes of autogenic drainage three times per week. Demographic data (age, gender, ethnicity) will be collected. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates.
- Conditions
- Cystic Fibrosis in Children
- Being tested
- Jamboxx Respiratory Therapy Device, Autogenic Draining Training
- Keywords
- cystic fibrosis, autogenic drainage, respiratory therapy, videogaming therapy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jamboxx Respiratory Therapy DeviceDevice
The 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, and 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.
Autogenic Draining TrainingOther
A respiratory therapist will teach children how to conduct the autogenic draining technique (a series of exhalations and inhalations) by demonstrating the technique to them, and having them practice in their office. Children will also receive an informational packet and short video about the technique for reference
| Study group | Role | What they receive |
|---|---|---|
| Group A: Education & Gaming | Other | Children will participate in 1 initial training session where they will be taught by a RT to use autogenic drainage (AD). Patients will be sent home \& prescribed to practice the technique 15 minutes 3 times / week. At week 8 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform the AD sequence (percent accuracy). At the 8 week visit, the Jamboxx gaming device will be introduced, which will contain a game to guide them through the proper sequence of breathing for the AD technique. Patients will be sent home with a Jamboxx device and requested to do 15 minutes of AD training 3 times / week. Patients will return at week 16 and again will be tested via software program for ability to perform the AD technique. Receives: Device: Jamboxx Respiratory Therapy Device; Other: Autogenic Draining Training |
| Group B: Gaming Only | Experimental | Children will participate in an initial training session at Albany Med where they will be taught by a RT to use the Jamboxx respiratory therapy device to guide them through autogenic drainage (AD): a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week. At week 8 and week 16 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform AD sequence (percent accuracy). Receives: Device: Jamboxx Respiratory Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in accuracy with the autogenic draining technique
A software program has been developed by the study team to evaluate ability to perform autogenic drainage sequence (percent accuracy). This program will be installed on the Jamboxx Respiratory Therapy device (without the associated games), and uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a change in percent accuracy from the baseline value to the end of the 16 week study.
Measured: Weeks 0, 8, 16
Secondary outcomes (2)
Cystic Fibrosis Questionnaire- Revised
A study developed by the Cystic Fibrosis Foundation to evaluate respiratory function and overall health and wellbeing for children living with CF
Measured: Weeks 0, 16
Clinically relevant events & exacerbations
e.g. patient being sent for a chest x-ray, being ordered chest physiotherapy, prescribed to new systemic antibiotics, hospital admission
Measured: Weeks 0, 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start30 Jan 2019
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Why it stopped: Change of Research Objectives for Grant Funded Study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis in ChildrenStudies 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
- Participants will be randomly assigned to one of two study groups: A or B. Participants assigned to study group A will be taught by a respiratory therapist how to perform the autogenic drainage technique in week 0, and will be asked to perform the technique regularly on their own for secretion clearance for the first 8 weeks of the study. Beginning in week 8, they will be taught to use autogenic draining technique guided by a videogame through the Jamboxx respiratory therapy device and will be advised to perform the technique regularly using the game for guidance through week 16 Participants in group B will be taught to perform the autogenic draining technique using the Jamboxx respiratory therapy guided by a videogame in week 0, and will be instructed to perform the technique regularly for the next 16 weeks using the game for guidance
- 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 Center IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522480
- Sponsor's protocol ID
- Jamboxx RT Device Study 2
- Other IDs
- 4R42HL132735-02
- Status last verified
- Jan 2019
- First submitted
- 26 Apr 2018
- Last updated
- 2 Sep 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 2 Sep 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 2: Children With Cystic Fibrosis for Long Term Evaluation
- ClinicalTrials.gov ID
- NCT03522480
- Acronym / sponsor ID
- Jamboxx RT Device Study 2
- Conditions
- Cystic Fibrosis in Children
- Keywords
- cystic fibrosis, autogenic drainage, respiratory therapy, videogaming therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of Research Objectives for Grant Funded Study
- 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
- 30 Jan 2019 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 11 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.
This study addresses the ongoing challenge of clearing the burden of bronchial secretions resulting from cystic fibrosis. These patients are dependent upon mechanical devices to help clear secretions. A device autonomous means for clearing secretions is well defined in the literature (autogenic drainage) but is difficult to learn. This study proposes to teach cystic fibrosis patients to master autogenic drainage, and seeks to determine at what age it can be taught. As it would be expected that gaming could easily teach adults this procedure, the study will include children for whom learning autogenic drainage based upon conceptualization would be expected to be very difficult.
Detailed description
Testing Plan: Children will be randomized into one of two groups via a random number generation software program
Group A (education \& gaming): Children will participate in 1 initial training session at Albany Med where they will be taught by a respiratory therapist (RT) to use autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to practice the autogenic draining technique 15 minutes three times per week. At week 8 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy. At the 8 week visit, the Jamboxx gaming device will be introduced through a training session with a RT, which will contain a game to guide them through the proper sequence of breathing for the autogenic draining technique. Patients will be sent home with a Jamboxx device and requested to do 15 minutes of autogenic drainage training three times a week. Patients will return for a research visits at week 16 and again will be tested via software program for ability to perform the autogenic drainage technique.
Group B (gaming only): Children will participate in an initial training session at Albany Med where they will be taught by a RT to use Jamboxx respiratory thearpy device to guide them through autogenic drainage: a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week. At week 8 and week 16 +/- 1 week patients will return for study visits and will be tested by a software program designed to evaluate their ability to perform autogenic drainage sequence (percent accuracy). This will be done through a software program installed on the device that uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a percent accuracy.
This protocol does not replace prescribed chest physiotherapy. There is no alteration of the standard of care beyond 15 minutes of autogenic drainage three times per week. Demographic data (age, gender, ethnicity) will be collected. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two study groups: A or B. Participants assigned to study group A will be taught by a respiratory therapist how to perform the autogenic drainage technique in week 0, and will be asked to perform the technique regularly on their own for secretion clearance for the first 8 weeks of the study. Beginning in week 8, they will be taught to use autogenic draining technique guided by a videogame through the Jamboxx respiratory therapy device and will be advised to perform the technique regularly using the game for guidance through week 16 Participants in group B will be taught to perform the autogenic draining technique using the Jamboxx respiratory therapy guided by a videogame in week 0, and will be instructed to perform the technique regularly for the next 16 weeks using the game for guidance
| Arm | Type | Receives |
|---|---|---|
| Group A: Education & Gaming | Other | Device: Jamboxx Respiratory Therapy Device, Other: Autogenic Draining TrainingChildren will participate in 1 initial training session where they will be taught by a RT to use autogenic drainage (AD). Patients will be sent home \& prescribed to practice the technique 15 minutes 3 times / week. At week 8 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform the AD sequence (percent accuracy). At the 8 week visit, the Jamboxx gaming device will be introduced, which will contain a game to guide them through the proper sequence of breathing for the AD technique. Patients will be sent home with a Jamboxx device and requested to do 15 minutes of AD training 3 times / week. Patients will return at week 16 and again will be tested via software program for ability to perform the AD technique. |
| Group B: Gaming Only | Experimental | Device: Jamboxx Respiratory Therapy DeviceChildren will participate in an initial training session at Albany Med where they will be taught by a RT to use the Jamboxx respiratory therapy device to guide them through autogenic drainage (AD): a series of controlled breathing exercises that mobilizes mucous without inducing wheezing in patients with reactive airways. Patients will be sent home and prescribed to use the Jamboxx respiratory therapy device 15 minutes three times per week. At week 8 and week 16 +/- 1 week patients will return and will be tested by a software program designed to evaluate their ability to perform AD sequence (percent accuracy). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with CF requiring chest physiotherapy ages 5-17
Key exclusion criteria (1 listed)
- Children with lung function of <25% FEV, hypercapnia, or requiring supplemental oxygen 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 DeviceThe 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, and 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 A: Education & Gaming, Group B: Gaming Only |
| Autogenic Draining TrainingA respiratory therapist will teach children how to conduct the autogenic draining technique (a series of exhalations and inhalations) by demonstrating the technique to them, and having them practice in their office. Children will also receive an informational packet and short video about the technique for reference | Other | Group A: Education & Gaming |
Primary outcome
Change in accuracy with the autogenic draining technique
Time frame: Weeks 0, 8, 16
A software program has been developed by the study team to evaluate ability to perform autogenic drainage sequence (percent accuracy). This program will be installed on the Jamboxx Respiratory Therapy device (without the associated games), and uses a series of calibration breaths to fit a curve that models the individual patient's idealized autogenic drainage sequence, then maps their actual performance to this curve and calculates a change in percent accuracy from the baseline value to the end of the 16 week study.
2 secondary outcomes
Cystic Fibrosis Questionnaire- Revised
Time frame: Weeks 0, 16
Clinically relevant events & exacerbations
Time frame: Weeks 0, 8, 16
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 2 Sep 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 Center IRB
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 Autogenic Draining Training in people with Cystic Fibrosis in Children, 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 2 Sep 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 accuracy with the autogenic draining technique (time frame: Weeks 0, 8, 16). 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 2 Sep 2020.