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NCT06079866
Oran Park Mask External Clinical Study (3) Marketing Claims Study
NA trial testing Mask A (Oran Park Mask) then Mask B (Evora Mask) in Obstructive Sleep Apnea in 58 participants. Completed in 20 November 2023.
20 November 2023
Quick facts
| Lead sponsor | ResMed |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 4 October 2023 |
| Primary completion | 20 November 2023 |
| Estimated completion | 20 November 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Mask A (Oran Park Mask) then Mask B (Evora Mask)
- Mask B (Evora Mask) then Mask A (Oran Park Mask)
Conditions studied
- Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
Sponsor
ResMed — full company profile →
Who can join
18 and older, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home environment. Comparisons will be made against Fisher \& Paykel's Evora Full mask system (referred to as Mask B in this study protocol, an FDA cleared benchmark mask) and the participant's own mask. Patients diagnosed with Obstructive Sleep Apnea and are current CPAP users on a tube down full-face mask system will be recruited to the study to evaluate the Oran Park mask system and the Evora Full mask system for up to 7 nights each, in the home environment, whilst using their own CPAP device. The overall purpose is to evaluate the performance of the prototype Oran Park mask system compared to an FDA cleared benchmark mask (Evora Full) in relation to seal, comfort, usability, ease of use, preference, AHI, and objective therapy data.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06079866
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other ResMed trials
Trials by the same sponsor.
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- NCT05255744 — Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol · NA · unknown
- NCT03924817 — Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstru · recruiting
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 NCT06079866 (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 ResMed
- Last refreshed: 29 February 2024
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/NCT06079866.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing