An Investigation to Test a Prototype Nasal Mask in the Home Setting

Fisher & Paykel Healthcare

Status: Completed

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Treatments: Device: User Instructions of novel nasal mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT03752580

CIA-240

Details and patient eligibility

About

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.

Full description

This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. This investigation is designed to evaluate the interpretation by participants of the user instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects (Ethics reference 18/NTA/62).

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 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• OSA Mask Users
• 18+ years of age
• Ability to give informed consent

Exclusion criteria

• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm

Experimental group

Description:

Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.

Treatment:

Device: User Instructions of novel nasal mask