Clinical trial NCT06079866: Oran Park Mask External Clinical Study (3) Marketing Claims Study
Official title: Assessment of the Seal, Comfort, Usability, and Performance of the Oran Park Mask System in the Home Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Both masks (Oran Park Mask and Evora Mask (Mask A and Mask B)) will be worn for a period of 7 nights sequentially. Participants will complete a series of questionnaires upon completion.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 11 point Likert Scale Questionnaire
timeFrame: 7 days
Secondary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 7 days
measure: Leak
timeFrame: 7 days
measure: Pressure Differences
timeFrame: 7 days
measure: Compliance
timeFrame: 7 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sleep Data
state: California
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
affiliation: Clayton Sleep Institute
name: Matthew Uhles
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Data
name: Betsy Dauphin
role: PRINCIPAL_INVESTIGATOR
References: