Clinical trial NCT03272763: A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
Official title: A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After a period of baseline, all enrolled participants will be put on the same trial mask.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Trial Mask Comfort
timeFrame: 14 ± 5 days In-Home
measure: Trial Mask Performance - Objective
timeFrame: 14 ± 5 days In-Home
measure: Trial Mask Performance - Subjective
timeFrame: 14 ± 5 days In-Home
measure: Trial Mask Usability
timeFrame: During Visit Two - 20 minutes
measure: Trial Mask Ease-of-Use
timeFrame: 14 ± 5 days In-Home
Secondary outcomes:
measure: Mask Leak Data
timeFrame: 14 ± 5 days In-Home
measure: Seal Size Determination
timeFrame: 1 day-time appointment (1 hour) during Visit Two
measure: Efficacy Data
timeFrame: 14 ± 5 days In-Home
Other outcomes:
Locations:
city: Roseville
country: United States
facility: California Sleep Solutions
state: California
Study officials:
References: