Clinical trial NCT02938208: An Investigation to Test a Prototype Full-face Mask in the Home Setting
Official title: An Investigation to Test a Prototype Full-face Mask in the Home Setting
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: 2016-10-19
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 a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.

Detailed description: This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ).

Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask.

Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. 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 (Bhavi Ogra) as soon as possible.

Eligibility criteria: Inclusion Criteria

* 18+ years of age
* Diagnosed with OSA by a practicing physician
* Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)
* Existing full face mask users
* Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).

Exclusion Criteria

* Inability to give informed consent
* Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
* Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or think they may be pregnant

Primary outcomes:
measure: Objective mask leak data measurement (System Leak)
timeFrame: Up to 21 ± 6 days in-home
measure: Subjective Measurement of leak assessed using a Subjective Questionnaire
timeFrame: Up to 21 ± 6 days in-home
measure: Comfort assessed using a Subjective Questionnaire
timeFrame: Up to 21 ± 6 days in-home
measure: Stability assessed using a Subjective Questionnaire
timeFrame: Up to 21 ± 6 days in-home
measure: Draft assessed using a Subjective Questionnaire
timeFrame: Up to 21 ± 6 days in-home
measure: Noise assessed using a Subjective Questionnaire
timeFrame: Up to 21 ± 6 days in-home
Secondary outcomes:
measure: Preference of Mask assessed using a Subjective Questionnaire
timeFrame: Up to 21 ± 6 days in-home
measure: Usability via mask unboxing/fitting exercise with a subjective questionnaire
timeFrame: Up to 21 ± 6 days in-home
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
city: Wellington
country: New Zealand
facility: Wellsleep: Bowen Hospital
Study officials:
affiliation: Sponsor Employee
name: Kayan Gonda, BSc
role: PRINCIPAL_INVESTIGATOR
References: