The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03413098

Enrollment

Registered

2018-01-29

Start date

2018-02-12

Completion date

2018-03-09

Last updated

2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.

Detailed description

Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial nasal mask for use in-home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

Interventions

DEVICENasal CPAP mask

Investigative Nasal Mask to be used for OSA therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult (18+ years of age) * Able to give consent * Apnea hypopnea Index (AHI)≥ 5 on diagnostic night * Prescribed PAP for OSA * Existing nasal mask user

Exclusion criteria

* Inability to give consent * Patients who are in a coma or a decreased level of consciousness * Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) * Commercial drivers who are investigated by New Zealand Transport Agency * Current diagnosis of carbon dioxide (CO2) retention * Pregnant or may think they are pregnant

Design outcomes

Primary

Measure	Time frame	Description
Ease of use	2 weeks	Subjective Questionnaire
Acceptability	2 weeks	Subjective Questionnaire

Secondary

Measure	Time frame	Description
Objective leak data	2 weeks	Data obtained from participant's device - Objective

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026