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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752580
• Other study ID #: CIA-240
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: July 2018
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 19, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• OSA Mask Users

• 18+ years of age

• Ability to give informed consent

Exclusion Criteria:

• Inability to give informed consent

Related Conditions & MeSH terms

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

Intervention

Device:
• User Instructions of novel nasal mask
User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	Auckland

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