MedTrace Logo

A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry

NCT04429009 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-08-25

No results posted yet for this study

Summary

The primary aim of this randomized control trial is to analyze by direct comparison the ZEPHYRx Respiratory Therapy (RT) system and the FDA approved standard of care (SOC) incentive spirometer (IS), used for FDA approved indications at the University of Rochester Medical Center (URMC). This comparison will determine subject preferences in terms of usability and simplicity of each, as well as subject engagement and adherence to the prescribed respiratory therapy routine. Additionally, the study will analyze the effectiveness of the gamified spirometry with regards to spirometry volumes, frequency of usage, and pulmonary complications 30 days post discharge.

Conditions

  • Thoracic Surgery
  • Respiratory Therapy

Interventions

DEVICE

ZEPHYRx Respiratory Therapy (RT) System

A breath controlled video game system for respiratory therapy

DEVICE

Standard Incentive Spirometer

A simple (not digital) plastic device that contains a piston that rises inside the device and measures the volume of your breath

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • My Music Machines Inc.

    lead INDUSTRY

Principal Investigators

  • Michal Lada, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-08-31
Completion
2023-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04429009 on ClinicalTrials.gov