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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142438
• Other study ID #: CIA-207
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: June 23, 2017

Study information

• Verified date: June 2021
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 23, 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	North texas Lung and Sleep Clinic	Fort Worth	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	North Texas Lung & Sleep Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	14 ± 4 days in-Home
Primary	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	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
Secondary	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
Secondary	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
Secondary	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