Clinical trial NCT03533400: Effectiveness of Jamboxx Respiratory Therapy Device: Study 1
Official title: The Effectiveness of the Jamboxx Respiratory Therapy Device in Treatment of Patients With Decreased Respiratory Function. Study 1: Spinal Cord Injury Patients for Long Term Evaluation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Respiratory Complication
Keywords: respiratory therapy
videogaming therapy
incentive spirometry
Lead sponsor: My Music Machines Inc.
Sponsor class: INDUSTRY
Collaborators: name: Albany Medical College
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
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.

Detailed description: Study 1 addresses the concerns of pneumonia risks in quadriplegics with compromised respiratory pump mechanics. In cases of spinal cord injury or high-level motor neuron disease, complications with respiratory function are a common concern. Lack of innervation to the intercostal and abdominal muscles can cause a decline in respiratory capacity as well as overall lung function, with associated increased risk of mortality. Shallow tidal breathing and impaired or absent cough results in morbidity and mortality from pneumonia. Several studies have found failure of the respiratory system, including pneumonia, to be a leading cause of mortality among spinal cord injury patients. In order to maintain pulmonary health, many people with quadriplegia and other high-level motor neuron diseases undergo routine respiratory therapy to help stretch the muscles around the lungs, exercise the diaphragm, and loosen mucus build-up. Incentive spirometry is one commonly used component of respiratory therapy designed to mimic natural sighing or yawning by encouraging the patient to take long, slow, deep breaths. This is done with an incentive spirometer device, which provides patients with visual or other positive feedback with a piston or a ball that moves inside a gauge. Respiratory therapy techniques are also used to help maintain pulmonary health in individuals with a number of chronic or temporary respiratory diseases and conditions such as asthma, chronic obstructive pulmonary disease, and emphysema. These techniques often become strenuous and mundane for users with limited mobility, and thus patient compliance rates are low. Gaming controlled by forceful respiratory maneuvers will be studied to ascertain if respiratory mechanics can be improved in this group.

Testing Plan: Study participants will be randomized into 2 groups through drawing of sealed envelopes. Group 1 (control group) will be given the standard Jamboxx musical device (see appendix a for device details), while Group 2 (treatment group) will be given the Jamboxx respiratory therapy device, which combines musical gameplay with incentive spirometry exercises. Participants from both groups will have two 20 minute training sessions with the device: one initial training visit and one follow up visit. Training sessions will take place either in the home, or at Albany Medical Center. During the initial visit a simple spirometry test (FEV1, FVC and PEF) and maximum inspiratory and expiratory pressures (MIP and MEP) will be performed. These functions will be measured again at 3, 6, 9 \& 12 months by a respiratory therapist (RT). The Dyspnea-12 (D-12) questionnaire will be conducted at by the RT at months 0, 3, 6, 9, and 12. Self-Reported Patient Dyspnea and the Multidimensional Dyspnea Profile (MDP) will be reported electronically by study participants on a weekly basis. Medical records will be evaluated for relevant health history, medication use, and hospitalizations including dates. Access to medical records will be obtained by a signed medical release form.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Self-Reported Patient Dyspnea
timeFrame: reported 1x/ week for the duration of the 1 year study
Secondary outcomes:
measure: Multidimensional Dyspnea Profile
timeFrame: reported 1x/ week for the duration of the 1 year study
measure: Dyspnea-12 Questionnaire
timeFrame: Months 0, 3, 6, 9, 12
measure: FEV1
timeFrame: Months 0, 3, 6, 9, 12
measure: FVC
timeFrame: Months 0, 3, 6, 9, 12
measure: PEF
timeFrame: Months 0, 3, 6, 9, 12
measure: MEP
timeFrame: Months 0, 3, 6, 9, 12
measure: MIP
timeFrame: Months 0, 3, 6, 9, 12
measure: Device usability
timeFrame: Months 6, 12
measure: Clinically relevant events
timeFrame: Months 0, 3, 6, 9, 12
measure: Patient Empowerment
timeFrame: Months 0, 3, 6, 9, 12
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Marilyn Fisher, MD
role: STUDY_CHAIR
References: