Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)

NCT03329352 | Completed Results DMC FDA Device

• 1 other identifier: CIA-227
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (5)

• Trial Mask Comfort

  Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).

  14 ± 5 days in-home

• Participant Count of Acceptable Trial Mask Performance - Objective

  Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective

  14 ± 5 days in-home

• Trial Mask Seal Performance - Subjective

  Determined from questionnaire - Subjective Uses a 5 point Likert Scale

  14 ± 5 days in-home

• Trial Mask Ease of Cleaning

  Determined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.

  14 ± 5 days in-home

• Trial Mask Ease-of-use

  Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.

  14 ± 5 days in-home

Secondary Outcomes (2)

• Participant Count of Acceptable Mask Leak

  14 ± 5 days in-home

• Participant Count of Seal Size Determination

  1 day-time appointment (1 hour) Visit 2

Study Arms (1)

F&P Full-Face Mask

EXPERIMENTAL

Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3.

Device: F&P Full-Face Mask

Interventions

F&P Full-Face Mask DEVICE

The F\&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.

F&P Full-Face Mask

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI ≥ 5 from diagnostic PSG night
• Aged 22 and over (FDA defined as adult)
• Either prescribed APAP, CPAP or Bi-Level PAP for OSA
• Existing full-face mask users
• Fluent in spoken and written English

You may not qualify if:

• Inability to give informed consent
• Patient intolerant to CPAP therapy
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

North Texas Lung and Sleep Clinic

Fort Worth, Texas, 76109, 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

Results Point of Contact

• Title: Hanie Yee
• Organization: Fisher & Paykel Healthcare

Hanie.Yee@fphcare.co.nz

+64 9 574 0123

Study Officials

• David Ostransky, MD

  Board Certified Sleep Specialist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: After a period of baseline, all enrolled participants will be put on the same trial mask.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: November 3, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: November 10, 2021
• Results First Posted: September 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)