Clinical trial NCT04011826: The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
Official title: The Evaluation of a New 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: 2019-07-09
Enrollment: 45
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: The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a nasal, sub-nasal or pillows 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 nasal mask by a mask fitting expert for use in-home (Visit 2). There will be a follow up phone call to gain feedback or address any issues after 3±1 days. The participant will then 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 trail nasal 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 monthly phone call to gain feedback or address any issues during the extension. At the end of the six month extension period, the participants will return the trial nasal mask to the institution and give feedback on their experience using the mask in home in the form of a self-administered questionnaire. Participants will revert to their usual masks thereafter. Neither the participants nor the investigators will be blinded to the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of OSA by Physician
* ≥ 22 years of age
* ≥ 66 lbs
* Prescribed PAP or BPAP therapy for OSA
* Existing nasal, sub-nasal and pillows mask users
* Fluent in written and spoken English

Exclusion Criteria:

* Inability to give informed consent
* Pregnant or think they may be pregnant
* PAP Intolerant
* Anatomical or Physiological Conditions that make PAP inappropriate
* IPAP pressure of ≤25cmH20.
* PAP/BPAP therapy device without data recording capabilities
* Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen

Primary outcomes:
measure: Number of Participants Objective Trial Mask Performance
timeFrame: 14 ± 3 days in home
Secondary outcomes:
measure: Number of Participants Trial Mask Overall Simplicity of Use
timeFrame: 14 ± 3 days in home
measure: Number of Participants Subjective Trial Mask Comfort
timeFrame: 14 ± 3 days in home
measure: Number of Participants Overall Trial Mask Satisfaction
timeFrame: 14 ± 3 days in home
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
affiliation: Clinical Director
name: Mark Muehlbach
role: PRINCIPAL_INVESTIGATOR
References: