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

The Evaluation of a Full Face and Nasal Mask for the Treatment of Obstructive Sleep Apnea

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: F&P Seal Improvement Project

Detailed Description

Visit 1 will involve the participants being fitted with the F&P trial full face or nasal mask for use in-home.

The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of the study.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76109
      • North texas Lung and Sleep Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: F&P Seal Improvement Project; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Performance Reporting	Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea	14 ± 4 days in-Home
Number of Participants Reported Mask Acceptability	Acceptability 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 of Participants Subjective Comfort Reporting	Comfort 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 Subjective Reporting of Seal Performance	Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea	14 ± 4 days in-Home

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Collaborators: North Texas Lung & Sleep Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2017
• Primary Completion (ACTUAL): June 23, 2017
• Study Completion (ACTUAL): June 23, 2017

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CIA-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigation to inform product development team. Results will inform product development on the future of the product.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No