Clinical trial NCT03329352: Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 44
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: The 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 participants who currently use a full-face mask will be recruited.

The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.

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.

Data from initial 2 week trial is reported here.

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 full-face mask users
* 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: Trial Mask Comfort
timeFrame: 14 ± 5 days in-home
measure: Participant Count of Acceptable Trial Mask Performance - Objective
timeFrame: 14 ± 5 days in-home
measure: Trial Mask Seal Performance - Subjective
timeFrame: 14 ± 5 days in-home
measure: Trial Mask Ease of Cleaning
timeFrame: 14 ± 5 days in-home
measure: Trial Mask Ease-of-use
timeFrame: 14 ± 5 days in-home
Secondary outcomes:
measure: Participant Count of Acceptable Mask Leak
timeFrame: 14 ± 5 days in-home
measure: Participant Count of Seal Size Determination
timeFrame: 1 day-time appointment (1 hour) Visit 2
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: North Texas Lung and Sleep Clinic
state: Texas
Study officials:
affiliation: Board Certified Sleep Specialist
name: David Ostransky, MD
role: PRINCIPAL_INVESTIGATOR
References: