Obstructive Sleep ApneaNCT06932055
A Phase II Pilot Study of the Trillium Full Face Mask
A study testing Trillium Full Face Mask and AirFit F20 in people with Obstructive Sleep Apnea, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Trillium Full Face Mask and AirFit F20
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 39Show fewer
- 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)
- Advised by a health care provider to avoid magnets
- Patient or patient's household member, caregiver or bed partner in close vicinity that have implanted devices that may be affected by magnets, including but not limited to:
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates
- Screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal nerve stimulators
- Implanted devices labeled as MR (magnetic resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
- Paralysis of the hemi-diaphragm
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971
About this study
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
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
Read the detailed description
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 FFM (Full Face Mask). Subjects meeting all eligibility criteria will be enrolled and will be randomized. Based on their randomization, subjects will be asked to use either a new AirFit F20 mask or the Trillium investigational mask for approximately 15 consecutive days (±3 days) of use. They will return for a follow-up visit to complete surveys about their experience during the first treatment period. Subjects will then be crossed over to the other mask (i.e., AirFit F20 or Trillium) per the randomization assignment. Following a second 15-day period of home use, subjects will return for a final visit to complete surveys about their experience in the second treatment period and conclude participation in the investigation.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Trillium Full Face Mask, AirFit F20
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trillium Full Face MaskDevice
Also called Trillium
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.
AirFit F20Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Trillium then AirFit F20 sequence | Experimental | Participants will use Trillium for the first treatment period and AirFit F20 for the second treatment period Receives: 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 Receives: Device: AirFit F20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the approximately 15-day Trillium mask treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start15 Jul 2025
- Primary completion19 Aug 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Florida Lung & Sleep Associates
- Responsible party
- Sponsor
- Investigators
- Alaa El-Gendy, Principal investigator, Florida Lung & Sleep Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932055
- Sponsor's protocol ID
- SRC-301124-Trillium Pilot
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2025
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06932055
- Acronym / sponsor ID
- SRC-301124-Trillium Pilot
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Florida Lung & Sleep Associates
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 17 Apr 2025 (actual)
- Results
- Posted 28 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 FFM (Full Face Mask). Subjects meeting all eligibility criteria will be enrolled and will be randomized. Based on their randomization, subjects will be asked to use either a new AirFit F20 mask or the Trillium investigational mask for approximately 15 consecutive days (±3 days) of use. They will return for a follow-up visit to complete surveys about their experience during the first treatment period. Subjects will then be crossed over to the other mask (i.e., AirFit F20 or Trillium) per the randomization assignment. Following a second 15-day period of home use, subjects will return for a final visit to complete surveys about their experience in the second treatment period and conclude participation in the investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trillium then AirFit F20 sequence | Experimental | Device: Trillium Full Face MaskParticipants will use Trillium for the first treatment period and AirFit F20 for the second treatment period |
| Airfit F20 then Trillium sequence | Experimental | Device: AirFit F20Participants will use AirFit F20 for the first treatment period and Trillium for the second treatment period |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (39 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trillium Full Face MaskAlso: TrilliumThe 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 | Trillium then AirFit F20 sequence |
| AirFit F20The 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. | Device | Airfit F20 then Trillium sequence |
Primary outcome
Median Unintentional Leak During Trillium Mask Use
Time frame: During the approximately 15-day Trillium mask treatment period
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa El-Gendy principal investigator
Florida Lung & Sleep Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trillium Full Face Mask and AirFit F20 in people with Obstructive Sleep Apnea, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Unintentional Leak During Trillium Mask Use (time frame: During the approximately 15-day Trillium mask treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.