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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938208
• Other study ID #: CIA-198
• Status: Completed
• Phase: N/A
• First received: October 16, 2016
• Last updated: July 24, 2017
• Start date: November 3, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 31, 2017
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Intervention

Device:
• Jupiter Full Face Mask
Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	Auckland
New Zealand	Wellsleep: Bowen Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective mask leak data measurement (System Leak)	Obtained from participant's CPAP device, measured in L/min	Up to 21 ± 6 days in-home
Primary	Subjective Measurement of leak assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Primary	Comfort assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Primary	Stability assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Primary	Draft assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Primary	Noise assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Secondary	Preference of Mask assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Secondary	Usability via mask unboxing/fitting exercise with a subjective questionnaire	Usability activity during visit 2 with subjective questionnaire after activity	Up to 21 ± 6 days in-home