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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03605485

Enrollment

Registered

2018-07-30

Start date

2018-08-07

Completion date

2018-08-10

Last updated

2018-08-15

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 pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Detailed description

Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F&P trial nasal pillows mask for use in-lab. The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night. 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 participants within 1 week of the beginning of the study.

Interventions

DEVICENasal Pillows CPAP mask

Investigative Nasal pillows 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 pillows 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	1 night	Subjective Questionnaire
Acceptability	1 night	Subjective Questionnaire

Secondary

Measure	Time frame	Description
Objective Leak Data	1 night	Data obtained from participant's device - Objective

Countries

New Zealand

Outcome results

None listed

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