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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124069
• Other study ID #: CIA-211
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: September 30, 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 30, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Clinical Trials of Florida	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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)