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

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea
• Interventions: Device: User Instructions of novel nasal mask

• Registration Number: NCT03752580
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-10-15
• Primary Completion: 2018-10-18
• Study Completion: 2018-10-19
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-26
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm	User Instructions of novel nasal mask	Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.

Primary Outcome Measures

Name	Time	Method
Mask User Instructions Interpretation	3 days	Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand