Effectiveness of Jamboxx Respiratory Therapy Device: Study 1

NCT03533400 | Withdrawn DMC FDA Device

• 2 other identifiers: Jamboxx RT Device Study 14R42HL132735-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Respiratory Complication

Keywords

respiratory therapy; videogaming therapy; incentive spirometry

Outcome Measures

Primary Outcomes (1)

• 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

  reported 1x/ week for the duration of the 1 year study

Secondary Outcomes (10)

• Multidimensional Dyspnea Profile

  reported 1x/ week for the duration of the 1 year study

• Dyspnea-12 Questionnaire

  Months 0, 3, 6, 9, 12

• FEV1

  Months 0, 3, 6, 9, 12

• FVC

  Months 0, 3, 6, 9, 12

• PEF

  Months 0, 3, 6, 9, 12

Study Arms (2)

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.

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.

Device: Jamboxx Respiratory Therapy Device; Device: Jamboxx Musical Device

Interventions

Jamboxx Respiratory Therapy Device DEVICE

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.

Group 2

Jamboxx Musical Device DEVICE

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Quadriplegic and other spinal cord injury outpatients will be included.

You may not qualify if:

• Individuals already adhering to a daily regimen of prescribed respiratory therapy routine will be excluded.

Sponsors & Collaborators

• My Music Machines Inc.: lead
• Albany Medical College: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marilyn Fisher, MD

  Albany Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 23, 2018
• Study Start: December 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)