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NCT04429009
A Randomized Control Trial of ZEPHYRx Gamified Incentive Spirometry Compared to Traditional Spirometry
NA trial testing ZEPHYRx Respiratory Therapy (RT) System in Thoracic Surgery in 100 participants. Status unknown.
31 August 2023
Quick facts
| Lead sponsor | My Music Machines Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 1 September 2021 |
| Primary completion | 31 August 2023 |
| Estimated completion | 30 September 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ZEPHYRx Respiratory Therapy (RT) System
- Standard Incentive Spirometer
Conditions studied
- Thoracic Surgery — all drugs for Thoracic Surgery →
- Respiratory Therapy — all drugs for Respiratory Therapy →
Sponsor
My Music Machines Inc.
Who can join
Adults 18 to 75, any sex, with Thoracic Surgery or Respiratory Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04429009
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT06732193 — Fissios© and Postoperative Complications (FPoC Trial) · NA · recruiting
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Other My Music Machines Inc. trials
Trials by the same sponsor.
- NCT03533400 — Effectiveness of Jamboxx Respiratory Therapy Device: Study 1 · NA · withdrawn
- NCT03522480 — The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 2 · NA · withdrawn
- NCT03547349 — The Effectiveness of the Jamboxx Respiratory Therapy Device: Study 3 · NA · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04429009 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by My Music Machines Inc.
- Last refreshed: 25 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04429009.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing