A Phase II Pilot Study of the Trillium Full Face Mask

NCT06932055 | Completed Results

• 1 other identifier: SRC-301124-Trillium Pilot
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Median Unintentional Leak During Trillium Mask Use

  Unintentional leak was obtained from positive airway pressure device data during the approximately 15-day Trillium mask treatment period. For each participant, the median unintentional leak was calculated. The reported result is the mean of the participant-level median values and its 95% confidence interval. Lower values indicate less unintentional leak. The result was considered acceptable if the upper limit of the 95% confidence interval was less than 24 L/min.

  During the approximately 15-day Trillium mask treatment period

Other Outcomes (6)

• Expected Adverse Device Effects

  Approximately 15-day Trillium mask treatment period

• Comfort of Breathing During Trillium Mask Use

  After approximately 15-day Trillium mask treatment period

• Average Daily PAP Device Use Across All Study Days

  During each approximately 15-day mask treatment period

Study Arms (2)

Trillium then AirFit F20 sequence

EXPERIMENTAL

Participants will use Trillium for the first treatment period and AirFit F20 for the second treatment period

Device: Trillium Full Face Mask

Airfit F20 then Trillium sequence

EXPERIMENTAL

Participants will use AirFit F20 for the first treatment period and Trillium for the second treatment period

Device: AirFit F20

Interventions

Trillium Full Face Mask DEVICE

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.

Also known as: Trillium

Trillium then AirFit F20 sequence

AirFit F20 DEVICE

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.

Airfit F20 then Trillium sequence

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21-85 years (inclusive)
• Diagnosed with OSA, Established on PAP therapy for ≥90 days at the time of consent
• Currently prescribed and using fixed pressure, Auto CPAP, or BiPAP therapy on a regular basis (average PAP usage of ≥4 hours/night, ≥4 days per week for ≥3 months)
• Able to read, write, speak and understand English
• Willing and able to provide informed consent
• Willing and able to follow instructions and complete all activities required by the study
• Able to remove a sleep apnea mask without assistance
• Currently using a ResMed PAP therapy device with a connection to ResMed's AirView system
• Currently using ResMed AirFit F20

You may not qualify if:

• Significant risk of aspiration (i.e., active vomiting or taking a prescription drug that induces vomiting)
• Known allergy to silicone, latex, polyamide (nylon), spandex, polyurethane, acetal, polycarbonate, or polypropylene
• Active infection or inflammation in an area in contact with the mask
• Recent head or facial surgery unless cleared by a healthcare provider to resume regular therapy
• Planned head or facial surgery during the study
• Any congenital or acquired craniofacial malformations or abnormalities, acute trauma, or burns that would interfere with the mask's placement or ability to deliver therapy
• Employee or family member who works for Philips or any of its direct competitors in the sleep industry
• Prescribed oxygen at night or continuously
• Currently participating in another interventional research study or planned participation in another interventional clinical research study during the trial period
• Prescribed an ASV (adaptive servo-ventilation) device
• Prescribed mechanical ventilation
• Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks,
• Any unstable medical condition (e.g., uncontrolled cardiac, lung, or neurological disease) or limitation that would affect the participant's ability to complete trial activities
• Experiencing any acute illness (e.g., acute sinusitis, ear or eye infections, upper respiratory infections, pharyngitis, bronchitis, pleurisy, pneumonia, or facial dermatitis) that would impact their ability to use the mask and/or PAP therapy during the trial
• Pregnant (self-report)

Sponsors & Collaborators

• Florida Lung & Sleep Associates: collaborator
• Philips Clinical & Medical Affairs Global: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

This pilot study had a small, unpowered sample, limiting reliability. Enrollment was limited to established PAP therapy users already using AirFit F20, which may have introduced familiarity bias, underestimated effect sizes, and limited generalizability to new PAP users or users of other masks. AirFit F20 was the only comparator, so findings may not represent other competitor masks.

Results Point of Contact

• Title: Sara Garbin
• Organization: Philips

sara.garbin@philips.com

724-787-8550

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: July 15, 2025
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: September 28, 2026
• Results First Posted: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share