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NCT06079866 · ClinicalTrials.gov registry record · NA
Oran Park Mask External Clinical Study (3) Marketing Claims Study
A NA study, sponsored by ResMed.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
NCT06079866: Completed NA study, sponsored by ResMed.
NCT06079866 is a NA study that has completed, run by ResMed. The registered enrollment target is 58 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06079866, a NA study, has completed, sponsored by ResMed.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
Study Summary
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.
Primary Outcome
• Subjective scores will be collected from subjects on each attribute being assessed (e.g. seal, comfort, ease of use etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Interventions
- DEVICE Mask A (Oran Park Mask) then Mask B (Evora Mask)
- DEVICE Mask B (Evora Mask) then Mask A (Oran Park Mask)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2023-11-20 |
| Phase | NA |
What the finished NCT06079866 record still lists
NCT06079866 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Mask A (Oran Park Mask) then Mask B (Evora Mask) is the first listed.
NCT06079866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06079866 about?
NCT06079866 is a clinical study titled "Oran Park Mask External Clinical Study (3) Marketing Claims Study". 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...
What is the current status of trial NCT06079866?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2023-10-04. Estimated completion is 2023-11-20.
What interventions are being tested in trial NCT06079866?
The interventions under investigation include: Mask A (Oran Park Mask) then Mask B (Evora Mask) (DEVICE), Mask B (Evora Mask) then Mask A (Oran Park Mask) (DEVICE).
Who is sponsoring clinical trial NCT06079866?
This trial is sponsored by ResMed, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06079866's enrollment target sits among peer trials
58 1256th of 2000 higher than 740 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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