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

NCT ID: NCT02938208

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-03
• Study Completion Date: 2017-05-31

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.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jupiter Full Face Mask

Participants to use full face mask in-home for a 14 ± 3 days in-home.

Group Type: EXPERIMENTAL

Jupiter Full Face Mask

Intervention Type: DEVICE

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

Interventions

Jupiter Full Face Mask

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kayan Gonda, BSc

Role: PRINCIPAL_INVESTIGATOR

Sponsor Employee

Locations

Fisher & Paykel Healthcare

Auckland, , New Zealand

Wellsleep: Bowen Hospital

Wellington, , New Zealand

Countries

New Zealand

Other Identifiers

CIA-198

Identifier Type: -

Identifier Source: org_study_id