A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272763
• Other study ID #: CIA-225
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: October 9, 2018

Study information

• Verified date: May 2022
• 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:

This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.

This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).

The participant then will come in to return the mask (Visit Three) and give their 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 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 their Obstructive Sleep Apnea.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 9, 2018
• Est. primary completion date: October 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• AHI = 5 from the diagnostic night

• Aged 22 and over (FDA defined as default)

• Either prescribed APAP, CPAP or Bi-level PAP for OSA

• Existing Full-Face mask user

• Fluent in spoken and written English

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 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 Toffee mask
Trial Full-Face mask which comes with three seal sizes and two headgear sizes.

Locations

Country	Name	City	State
United States	California Sleep Solutions	Roseville	California

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	Trial Mask Comfort	Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective	14 ± 5 days In-Home
Primary	Trial Mask Performance - Objective	Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective	14 ± 5 days In-Home
Primary	Trial Mask Performance - Subjective	Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective	14 ± 5 days In-Home
Primary	Trial Mask Usability	Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective	During Visit Two - 20 minutes
Primary	Trial Mask Ease-of-Use	Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective	14 ± 5 days In-Home
Secondary	Mask Leak Data	Leak data recorded from PAP device - Objective	14 ± 5 days In-Home
Secondary	Seal Size Determination	Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.	1 day-time appointment (1 hour) during Visit Two
Secondary	Efficacy Data	AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective	14 ± 5 days In-Home