The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 3

NCT03547349 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-08-24

No results posted yet for this study

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 (see appendix A for device details) 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 postoperative pulmonary atelectasis that results from diaphragm dysfunction and pain following upper abdominal surgery. This issue is a major cause of morbidity in these patients (Ford et al 1983). Incentive spirometry is used in this setting, but there is conflicting data regarding its effectiveness (Rupp et al 2013). Study 3 will focus on the questions regarding the influence of education and a novel use of a gaming device on prevention of atelectasis. Study 3 will include 3 subgroups of subjects. The first subject group will be enrolled in a nonintrusive observation only studies. Group 1 will explore the effect of technology via a tablet device on standard spirometry usage. Group 2 will look at the combined effect of technology via the tablet device and intensive education on compliance and reduction of post-surgical atelectasis. Finally, Group 3 will explore the effect of gaming technology with intensive educational reinforcement on compliance and reduction of post-surgical atelectasis.

Conditions

  • Atelectases, Postoperative Pulmonary

Interventions

DEVICE

Digital Incentive Spirometer

This device is an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer

DEVICE

Jamboxx Respiratory Therapy Device

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.

Sponsors & Collaborators

  • Albany Medical College

    collaborator OTHER
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • My Music Machines Inc.

    lead INDUSTRY

Principal Investigators

  • Marilyn Fisher, MD · Albany Medical Center IRB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-03-10
Completion
2021-03-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547349 on ClinicalTrials.gov