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

NCT06079866 | Completed FDA Device

• 2 other identifiers: SLP-23-04-01D646-159
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days

Secondary Outcomes (4)

• Apnea Hypopnea Index (AHI)

  7 days

• Leak

  7 days

• Pressure Differences

  7 days

• Compliance

  7 days

Study Arms (2)

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

OTHER

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.

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

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

OTHER

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.

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (2)

Sleep Data

San Diego, California, 92123, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew Uhles

  Clayton Sleep Institute

  PRINCIPAL INVESTIGATOR

• Betsy Dauphin

  Sleep Data

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 4, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: February 29, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)