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

Back to results

Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sleep Data
Clayton Sleep Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

11 point Likert Scale Questionnaire

• 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 Outcome Measures

Apnea Hypopnea Index (AHI)

• 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.

Leak

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.

Pressure Differences

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.

Compliance

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.

Full Information

NCT ID

NCT06079866

First Posted

October 6, 2023

Last Updated

October 6, 2023

Sponsor

ResMed

1. Study Identification

Unique Protocol Identification Number

NCT06079866

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

October 4, 2023 (Actual)

Primary Completion Date

November 15, 2023 (Anticipated)

Study Completion Date

November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Other

Arm Description

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.

Arm Title

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

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

11 point Likert Scale Questionnaire

Description

• 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.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Apnea Hypopnea Index (AHI)

Description

• 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.

Time Frame

7 days

Title

Leak

Description

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.

Time Frame

7 days

Title

Pressure Differences

Description

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.

Time Frame

7 days

Title

Compliance

Description

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.

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew Uhles

Organizational Affiliation

Clayton Sleep Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Betsy Dauphin

Organizational Affiliation

Sleep Data

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sleep Data

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Clayton Sleep Institute

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63123

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Obstructive Sleep Apnea

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial