An Investigation to Test a Prototype Full-face Mask in the Home Setting

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing

• Registration Number: NCT02938208
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Study Timeline

• Study First Submitted: 2016-10-16
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Study Start: 2016-11-03
• Primary Completion: 2016-11-21
• Study Completion: 2017-05-31
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective mask leak data measurement (System Leak)	Up to 21 ± 6 days in-home	Obtained from participant's CPAP device, measured in L/min
Subjective Measurement of leak assessed using a Subjective Questionnaire	Up to 21 ± 6 days in-home	Subjective Questionnaire
Comfort assessed using a Subjective Questionnaire	Up to 21 ± 6 days in-home	Subjective Questionnaire
Stability assessed using a Subjective Questionnaire	Up to 21 ± 6 days in-home	Subjective Questionnaire
Noise assessed using a Subjective Questionnaire	Up to 21 ± 6 days in-home	Subjective Questionnaire
Draft assessed using a Subjective Questionnaire	Up to 21 ± 6 days in-home	Subjective Questionnaire

Secondary Outcome Measures

Name	Time	Method
Preference of Mask assessed using a Subjective Questionnaire	Up to 21 ± 6 days in-home	Subjective Questionnaire
Usability via mask unboxing/fitting exercise with a subjective questionnaire	Up to 21 ± 6 days in-home	Usability activity during visit 2 with subjective questionnaire after activity

Trial Locations

Locations (2)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand

Wellsleep: Bowen Hospital; 🇳🇿 Wellington, New Zealand