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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03142438

Enrollment

Registered

2017-05-05

Start date

2017-05-30

Completion date

2017-06-23

Last updated

2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

DEVICEF&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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Subjective Usability Reporting	14 ± 4 days in-Home	Usability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number or Participants Comparative Subjective Reported Comfort	14 ± 4 days in-Home	Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea compared to usual

Secondary

Measure	Time frame	Description
Objective Performance Reporting	14 ± 4 days in-Home	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
Number of Participants Reported Mask Acceptability	14 ± 4 days in-Home	Acceptability reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Comfort Reporting	14 ± 4 days in-Home	Comfort reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea
Number or Participants Subjective Reporting of Seal Performance	14 ± 4 days in-Home	Seal performance reported from participants questionnaires to evaluate the use of the F&P mask for treatment of Obstructive Sleep Apnea

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 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.	57
Total	57

Baseline characteristics

Characteristic	F&P Seal Improvement Project
Age, Customized 22 or older	57 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Region of Enrollment New Zealand	5 Participants
Region of Enrollment United States	52 Participants
Sex: Female, Male Female	19 Participants
Sex: Female, Male Male	38 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 57
other Total, other adverse events	0 / 57
serious Total, serious adverse events	0 / 57

Outcome results

Primary

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