A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: F&P Saturn

Detailed Description

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited

This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.

The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33186
      • Clinical Trials of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• AHI ≥ 5 from diagnostic PSG night
• Aged 22 and over (FDA defined as adult)
• Either prescribed APAP, CPAP or Bi-Level PAP for OSA
• Existing nasal or nasal pillows mask users (preferable 70%:30% split)
• Fluent in spoken and written English

Exclusion Criteria:

• Inability to give informed consent
• Patient intolerant to CPAP therapy
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F&P Saturn; Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.	Device: F&P Saturn; Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Comfort Compared to Their Usual Mask.	Comfort reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	14 ± 5 days In-Home
Number of Participants PAP Device Performance Reporting	Determined from data recorded from the PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	14 ± 5 days In-Home
Number of Participants Subjective Performance Rating of the Nasal Mask	Performance reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	14 ± 5 days In-Home
Number of Participants Subjective Reporting of Nasal Mask Usability	Usability reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	During Visit Two - 20 minutes
Number of Participants Subjective Recording of Ease of Nasal Mask Use.	Ease of use reported from participants questionnaires to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	14 ± 5 days In-Home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Leak Compared to Usual Mask	Leak data recorded from PAP device to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	14 ± 5 days In-Home
Number of Participants With Correct Nasal Mask Size Determination	Sizing determined from a customized fitting tool to evaluate the use of the F&P nasal mask for treatment of Obstructive Sleep Apnea	1 day-time appointment (1 hour)

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): May 26, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 21, 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-211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with any other researchers or parties.

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