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OpenTrials
Completed

NCT Number: NCT06079866

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 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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Data, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Device

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

Primary outcomes

  1. 11 point Likert Scale Questionnaire

    Time frame: 7 days

    • 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.

Secondary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: 7 days

    • The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Oran Park mask and the Evora Mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.

  2. Leak

    Time frame: 7 days

    The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Oran Park mask and the Evora mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.

  3. Pressure Differences

    Time frame: 7 days

    The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Oran Park mask and the Evora mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.

  4. Compliance

    Time frame: 7 days

    The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Oran Park mask and the Evora mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

Assessment of the Seal, Comfort, Usability, and Performance of the Oran Park Mask System in the Home Environment

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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