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

NCT ID: NCT06079866

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-04
• Study Completion Date: 2023-11-20

Brief 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

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Participants will be randomized as to the order they will trial Mask A and Mask B. This arm will first use the Oran Park mask for 7 days and then use the Evora Mask for 7 days.

Group Type: OTHER

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

Intervention Type: DEVICE

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

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

Participants will be randomized as to the order they will trial Mask A and Mask B. This arm will first use the Evora mask for 7 days and then use the Oran Park mask for 7 days.

Group Type: OTHER

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participants willing to give written informed consent
• Participants who can read and comprehend English
• Participants who ≥ 18 years of age
• Participants being treated for OSA for ≥ 12 months
• Participants who have met CMS compliance for CPAP therapy over the last 3 months
• Participants who have been using a ResMed cloud connected AirSense10 or AirSense 11 device compatible with AirView, for more than 12 months
• Participants currently using a suitable mask system*
• Participants who can trial the masks for up to 7 nights each

• Note*: Suitable mask system includes any tube down full face mask (e.g. AirFit F30, AirFit F20, AirTouch F20, AirFit F10, Quattro Air, Quattro Fx, Mirage Quattro, Simplus, Amara, Amara Gel, Comfort gel Full Face Mask, Evora Full)

Exclusion Criteria

• Participants using Bi-level flow generators
• Participants who are or may be pregnant
• Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
• Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
• Participants who use a rental unit for AirSense 10 or AirSense 11 device
• Participants believed to be unsuitable for inclusion by the researcher

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Uhles

Role: PRINCIPAL_INVESTIGATOR

Clayton Sleep Institute

Betsy Dauphin

Role: PRINCIPAL_INVESTIGATOR

Sleep Data

Locations

Sleep Data

San Diego, California, United States

Clayton Sleep Institute

St Louis, Missouri, United States

Countries

United States

Other Identifiers

D646-159

Identifier Type: OTHER

Identifier Source: secondary_id

SLP-23-04-01

Identifier Type: -

Identifier Source: org_study_id