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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 is a NA study that has completed, run by ResMed. The registered enrollment target is 58 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06079866
The ClinicalTrials.gov registry entry for NCT06079866 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ResMed, which has 25 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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