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The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03547349
Recruitment Status : Suspended (COVID-19)
First Posted : June 6, 2018
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Albany Medical College
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
My Music Machines Inc.

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 (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.


Condition or disease Intervention/treatment Phase
Atelectases, Postoperative Pulmonary Device: Digital Incentive Spirometer Device: Jamboxx Respiratory Therapy Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be enrolled sequentially in Group 1 until the desired group enrollment number is met (N=25) at which point participants will be randomized into groups 2 and 3, stratified by surgery type (open or laproscopic)
Masking: Single (Outcomes Assessor)
Masking Description: Incidence and severity of atelectasis will be radiographically assessed on a 5 point scale (no apparent disease, subsegmental atelectasis, segmental atelectasis, lobar atelectasis, or pneumonia) by a chest radiologist and two pulmonary physicians blinded to study group assignment.
Primary Purpose: Prevention
Official Title: The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 3: Post-Op Inpatients for Short Term Evaluation of Atelectasis
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Active Comparator: Group 1
These study patients will receive a study information/authorization sheet about the study prior to surgery during their pre-operative clinic visit. This subgroup will be provided postoperatively with a digital 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. Subjects in this group will receive current standard of care with routine surgical and RN encouragement to use the spirometer. The tablet will monitor and record spirometer device utilization.
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

Active Comparator: Group 2
These study patients will be consented by members of the research team prior to surgery at their pre-operative clinic visit. The patient will receive RT or RN education preoperatively as to the importance of incentive spirometry in prevention of post-operative respiratory complications. This subgroup will be provided with a digital 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, and will set a spirometry goal while collecting usage and pulmonary function data. Subjects in this group will also receive daily intensive education from a study team member during the postoperative time up until 72 hours or until discharge.
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

Experimental: Group 3
These study patients will be consented by a member of the research team prior to surgery at their pre-operative clinic visit. The patients will receive RT or RN education preoperatively as to the importance of incentive spirometry in prevention of post-operative respiratory complications. This subgroup will be provided with both intensive education reinforcement and the Jamboxx Respiratory Therapy Device that also includes multiple gaming programs. The games are meant to encourage incentive spirometry and are programmed to progress in accordance with the patient's personal increasing capacity. Subjects in this group will also receive daily intensive education from a study team member during the postoperative time up until 72 hours or until discharge.
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.




Primary Outcome Measures :
  1. Severity of atelectasis [ Time Frame: 48 hours post-surgery ]
    Severity of atelectasis radiographically assessed on a 5 point scale (1. no apparent disease, 2. subsegmental atelectasis, 3. segmental atelectasis, 4. lobar atelectasis, or 5. pneumonia) by a chest radiologist and two pulmonary physicians blinded to study group assignment. Within this scale range, no apparent disease represents the best possible outcome, while pneumonia represents the worst possible outcome


Secondary Outcome Measures :
  1. Device Utilization Time [ Time Frame: 72 hours post surgery or time of discharge, whichever comes first ]
    total usage time (in minutes) as recorded by the digital device

  2. Device Uses [ Time Frame: 72 hours post surgery or time of discharge, whichever comes first ]
    Total number of uses as recorded by the digital device

  3. Pulse Oximetry [ Time Frame: 3x/ day (except between hours of 10pm and 6am) until 72 hour post-surgery mark or time of discharge, whichever comes first ]
    Pulse Oximetry off of supplemental oxygen

  4. Clinically relevant events [ Time Frame: 72 hours post surgery or time of discharge, whichever comes first ]
    e.g. patient being sent for a chest x-ray, being ordered chest physiotherapy or increased oxygen requirement

  5. Incidence of hospital acquired respiratory infection [ Time Frame: 72 hours post surgery or time of discharge, whichever comes first ]
    Incidence of hospital acquired respiratory infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-op patients with elective upper abdominal surgery including but not limited to: bariatric surgery, cholecystectomy, and bowel surgery

Exclusion Criteria:

  • Patients who go directly to the ICU from the PACU post-surgery.
  • Patients with visual impairments that make it difficult to understand written instructions
  • Patients with hearing impairments that make it difficult to understand verbal instructions
  • Patients who already receive supplemental oxygen therapy at home

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547349


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
My Music Machines Inc.
Albany Medical College
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Chair: Marilyn Fisher, MD Albany Medical Center IRB
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Responsible Party: My Music Machines Inc.
ClinicalTrials.gov Identifier: NCT03547349    
Other Study ID Numbers: Jamboxx RT Device Study 3
4R42HL132735-02 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by My Music Machines Inc.:
respiratory therapy
videogaming therapy
incentive spirometry
atelectases
Additional relevant MeSH terms:
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Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases