Clinical trial NCT03075722: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
Official title: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington.

Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial.

This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Able to give consent
* AHI ≥ 5 on diagnostic night
* Prescribed a CPAP device after successful OSA diagnosis
* Existing nasal or nasal pillow mask user

Exclusion Criteria:

* Inability to give consent
* Participants who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.

Primary outcomes:
measure: Comfort
timeFrame: Up to 7 ± 3 days in-home
measure: Stability
timeFrame: Up to 7 ± 3 days in-home
measure: Objective leak data
timeFrame: Up to 7 ± 3 days in-home
measure: Subjective measurement of leak
timeFrame: Up to 7 ± 3 days in-home
measure: Draft
timeFrame: Up to 7 ± 3 days in-home
measure: Treatment efficacy
timeFrame: Up to 7 ± 3 days in-home
measure: Noise
timeFrame: Up to 7 ± 3 days in-home
Secondary outcomes:
measure: Preference of mask
timeFrame: Up to 7 ± 3 days in-home
measure: Usability
timeFrame: Up to 7 ± 3 days in-home
Other outcomes:
Locations:
city: Wellington
country: New Zealand
facility: Bowen Hospital
Study officials:
References: