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Oran Park Mask External Clinical Study (3) Marketing Claims Study

NCT06079866 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-02-29

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Mask A (Oran Park Mask) then Mask B (Evora Mask)

Mask A (Oran Park Mask) for 7 days followed by Mask B (Evora Mask) for 7 days

DEVICE

Mask B (Evora Mask) then Mask A (Oran Park Mask)

Mask B (Evora Mask) for 7 days followed by Mask A (Oran Park Mask) for 7 days.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • Matthew Uhles · Clayton Sleep Institute

  • Betsy Dauphin · Sleep Data

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2023-11-20
Completion
2023-11-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT06079866 on ClinicalTrials.gov