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COMPLETED
NCT06932055

A Phase II Pilot Study of the Trillium Full Face Mask

Sponsor: Philips Clinical & Medical Affairs Global

View on ClinicalTrials.gov

Summary

This will be a single-center, open-label randomized crossover design pilot study to evaluate the clinical safety, clinical performance, and clinical benefit of the Trillium full face mask

Official title: A Phase II Randomized Crossover Pilot Study to Assess Clinical Safety, Performance, and Benefit of the Trillium Full Face Mask in Patients With Obstructive Sleep Apnea

Key Details

Gender

All

Age Range

21 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-15

Completion Date

2025-08-19

Last Updated

2026-09-28

Healthy Volunteers

No

Interventions

DEVICE

Trillium Full Face Mask

The Trillium Full Face Mask (FFM) (Philips Respironics, Murrysville, PA) is an over-the-nose, full-face mask with the hose connection in the front. The mask is used with a positive airway pressure (PAP) therapy device and covers both the nose and mouth, ensuring pressurized air is delivered directly into the patient's airways.

DEVICE

AirFit F20

The AirFit F20 (ResMed, San Diego, California) is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face. The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features.