Clinical trial NCT03522480: The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: cystic fibrosis
autogenic drainage
respiratory therapy
videogaming therapy
Lead sponsor: My Music Machines Inc.
Sponsor class: INDUSTRY
Collaborators: name: Albany Medical College
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in accuracy with the autogenic draining technique
timeFrame: Weeks 0, 8, 16
Secondary outcomes:
measure: Cystic Fibrosis Questionnaire- Revised
timeFrame: Weeks 0, 16
measure: Clinically relevant events & exacerbations
timeFrame: Weeks 0, 8, 16
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical Center IRB
name: Marilyn Fisher, MD
role: STUDY_CHAIR
References: