Clinical trial NCT03124069: A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official title: A Development Study to Evaluate a Nasal 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: 2017-04-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Reporting Comfort Compared to Their Usual Mask.
timeFrame: 14 ± 5 days In-Home
measure: Number of Participants PAP Device Performance Reporting
timeFrame: 14 ± 5 days In-Home
measure: Number of Participants Subjective Performance Rating of the Nasal Mask
timeFrame: 14 ± 5 days In-Home
measure: Number of Participants Subjective Reporting of Nasal Mask Usability
timeFrame: During Visit Two - 20 minutes
measure: Number of Participants Subjective Recording of Ease of Nasal Mask Use.
timeFrame: 14 ± 5 days In-Home
Secondary outcomes:
measure: Number of Participants Leak Compared to Usual Mask
timeFrame: 14 ± 5 days In-Home
measure: Number of Participants With Correct Nasal Mask Size Determination
timeFrame: 1 day-time appointment (1 hour)
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Clinical Trials of Florida
state: Florida
Study officials:
References: