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

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02938208
• Collaborator: (none)
• Enrollment: 14
• Locations: 2
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site: 7
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disordered Breathing; Obstructive Sleep Apnea	Device: Jupiter Full Face Mask	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Investigation to Test a Prototype Full-face Mask in the Home Setting
• Actual Study Start Date: Nov 3, 2016
• Actual Primary Completion Date: Nov 21, 2016
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Jupiter Full Face Mask Participants to use full face mask in-home for a 14 ± 3 days in-home.	Device: Jupiter Full Face Mask; Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.

Outcome Measures

Primary Outcome Measures

1. Objective mask leak data measurement (System Leak) [Up to 21 ± 6 days in-home]

   Obtained from participant's CPAP device, measured in L/min

2. Subjective Measurement of leak assessed using a Subjective Questionnaire [Up to 21 ± 6 days in-home]

   Subjective Questionnaire

3. Comfort assessed using a Subjective Questionnaire [Up to 21 ± 6 days in-home]

   Subjective Questionnaire

4. Stability assessed using a Subjective Questionnaire [Up to 21 ± 6 days in-home]

   Subjective Questionnaire

5. Draft assessed using a Subjective Questionnaire [Up to 21 ± 6 days in-home]

   Subjective Questionnaire

6. Noise assessed using a Subjective Questionnaire [Up to 21 ± 6 days in-home]

   Subjective Questionnaire

Secondary Outcome Measures

1. Preference of Mask assessed using a Subjective Questionnaire [Up to 21 ± 6 days in-home]

   Subjective Questionnaire

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fisher & Paykel Healthcare	Auckland		New Zealand	2013
2	Wellsleep: Bowen Hospital	Wellington		New Zealand	6035

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

• Principal Investigator: Kayan Gonda, BSc, Sponsor Employee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT02938208
• Other Study ID Numbers: CIA-198
• First Posted: Oct 19, 2016
• Last Update Posted: Jul 25, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Jul 25, 2017