Clinical trial NCT02730273: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Official title: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
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: 2016-04-06
Enrollment: 12
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 (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Inability to give consent
* Patients 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: Objective leak data (L/min)
timeFrame: Up to 1 week in-home
measure: Subjective measurement of leak
timeFrame: Up to 1 week in-home
measure: Comfort
timeFrame: Up to 1 week in-home
measure: Stability
timeFrame: Up to 1 week in-home
measure: Draft
timeFrame: Up to 1 week in-home
measure: Noise
timeFrame: Up to 1 week in-home
measure: Objective leak data (L/min)
timeFrame: 1 night
Secondary outcomes:
measure: Preference of the mask
timeFrame: Up to 1 week in-home
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
affiliation: Sponsor Employee
name: Kayan Gonda, BSc
role: PRINCIPAL_INVESTIGATOR
References: