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

NCT ID: NCT03142438

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2017-06-23

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

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

F&P Seal Improvement Project

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Texas Lung & Sleep Clinic

OTHER

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Ostransky, MD

Role: PRINCIPAL_INVESTIGATOR

Board Certified Sleep Specialist

Locations

North texas Lung and Sleep Clinic

Fort Worth, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIA-207

Identifier Type: -

Identifier Source: org_study_id