A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

NCT03272763 | Completed Results DMC FDA Device

• 1 other identifier: CIA-225
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This 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

  Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective

  14 ± 5 days In-Home

• Trial Mask Performance - Objective

  Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective

  14 ± 5 days In-Home

• Trial Mask Performance - Subjective

  Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective

  14 ± 5 days In-Home

• Trial Mask Usability

  Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective

  During Visit Two - 20 minutes

• Trial Mask Ease-of-Use

  Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective

  14 ± 5 days In-Home

Secondary Outcomes (3)

• Mask Leak Data

  14 ± 5 days In-Home

• Seal Size Determination

  1 day-time appointment (1 hour) during Visit Two

• Efficacy Data

  14 ± 5 days In-Home

Study Arms (1)

F&P Toffee mask

EXPERIMENTAL

Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.

Device: F&P Toffee mask

Interventions

F&P Toffee mask DEVICE

Trial Full-Face mask which comes with three seal sizes and two headgear sizes.

F&P Toffee 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 the diagnostic night
• Aged 22 and over (FDA defined as default)
• Either prescribed APAP, CPAP or Bi-level PAP for OSA
• Existing Full-Face mask user
• Fluent in spoken and written English

You may not qualify if:

• Inability to give informed consent
• Participant intolerant to PAP
• 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)

California Sleep Solutions

Roseville, California, 95661, 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: Rebecca Thomson
• Organization: Fisher & Paykel Healthcare Ltd.

Rebecca.Thomson@fphcare.co.nz

+64 9 574 0123

Publication Agreements

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

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: August 30, 2017
• First Posted: September 6, 2017
• Study Start: October 9, 2017
• Primary Completion: October 29, 2017
• Study Completion: October 9, 2018
• Last Updated: June 21, 2022
• Results First Posted: June 21, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)