The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea

NCT03142438 | Completed Results DMC FDA Device

• 1 other identifier: CIA-207
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Number of Participants Subjective Usability Reporting

  Usability reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea

  14 ± 4 days in-Home

• Number or Participants Comparative Subjective Reported Comfort

  Comfort reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea compared to usual

  14 ± 4 days in-Home

Secondary Outcomes (4)

• Objective Performance Reporting

  14 ± 4 days in-Home

• Number of Participants Reported Mask Acceptability

  14 ± 4 days in-Home

• Number of Participants Subjective Comfort Reporting

  14 ± 4 days in-Home

• Number or Participants Subjective Reporting of Seal Performance

  14 ± 4 days in-Home

Study Arms (1)

F&P Seal Improvement Project

EXPERIMENTAL

participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm

Device: F&P Seal Improvement Project

Interventions

F&P Seal Improvement Project DEVICE

Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.

F&P Seal Improvement Project

Eligibility Criteria

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

You may qualify if:

• Adult (22+ years of age)
• Able to give informed consent
• Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
• Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
• Fluent in spoken and written English
• Existing oronasal and nasal mask user

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 carbon Dioxide (CO2) retention
• Pregnant or may think they are pregnant.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead
• North Texas Lung & Sleep Clinic: collaborator

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

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: May 5, 2017
• Study Start: May 30, 2017
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: July 14, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)