The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 2/3/2019 |
| Start Date: | January 30, 2019 |
| End Date: | August 31, 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- Children with CF requiring chest physiotherapy ages 5-17
Exclusion Criteria:
- Children with lung function of <25% FEV, hypercapnia, or requiring supplemental oxygen
will be excluded.
We found this trial at
1
site
Albany, New York 12208
Principal Investigator: Thomas Smith, MD
Phone: 518-817-8798
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