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

NCT03142438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-07-14

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • North Texas Lung & Sleep Clinic

    collaborator OTHER

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • David Ostransky, MD · Board Certified Sleep Specialist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2017-06-23
Completion
2017-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142438 on ClinicalTrials.gov