An interventional study of Trillium and AirFit F20 in Sleep Apnea, Obstructive, sponsored by Philips Clinical & Medical Affairs Global. Completed at 1 site in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Not applicable, Interventional, and Treatment
Among 13 studies in Sleep Apnea, Obstructive by Philips — none open to participants now, none under way, none of them phase 3. Sleep Apnea, Obstructive · Philips.
Among the 13 studies in Sleep Apnea, Obstructive by Philips, this one is the 7th largest by enrollment, is the only one that started in 2026, is one of 13 with no phase, and was the 13th registered.
2,242 studies on the registry are indexed under Sleep Apnea, Obstructive; 474 are open to participants now.
Browse Sleep Apnea, Obstructive studies →None of the 13 studies in Sleep Apnea, Obstructive by Philips is open now. The open studies under Sleep Apnea, Obstructive, anywhere →
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.
This study: 21 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2026.
This study's enrollment of 45 is below the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 45 across the 13 interventional studies. Of the 12 that completed or were terminated, 9 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Philips Clinical & Medical Affairs Global, one of the names counted as Philips. Under that name alone:
Philips Clinical & Medical Affairs Global is the lead sponsor of 86 studies on the registry; 25 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 13 (81%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Sleep Apnea, Obstructive by Philips, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This will be a single-center, two-treatment, two-period, open-label, randomized crossover design pivotal study to validate the clinical safety, clinical performance, and clinical benefits of the Trillium Full Face Mask (FFM).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient or anyone in close physical contact during patient's use of the mask with any of the following:
Active medical implants that interact with magnets, including but not limited to:
Metallic implants/objects containing ferromagnetic material placed in upper limbs, torso, or higher (i.e., neck and head), including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use Trillium for the first treatment period and AirFit F20 for the second treatment period.
Device: Trillium · Device: AirFit F20
Participants will use AirFit F20 for the first treatment period and Trillium for the second treatment period.
Device: Trillium · Device: AirFit F20
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 Trillium Full Face Mask is intended to provide an interface for the application of non-invasive positive airway pressure (PAP) therapy. The mask is intended for single-patient reuse in the home environment and healthcare facilities and/or hospital environments. The mask is to be used by adult patients weighing more than 66lb (30kg) for whom non-invasive PAP therapy has been prescribed. The device is not intended for critical care patients.
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. The cushion and headgear are available in various sizes to fit a wide patient population. AirFit F20 is a prescription device supplied non-sterile.
Median Unintentional Leak
Unintentional leak was obtained from positive airway pressure device data during each approximately 15-day mask treatment period. For each participant, the median unintentional leak was calculated. The reported results are adjusted least squares (LS) means of the participant-level median values and their 95% confidence intervals. Lower values indicate less unintentional leak. For the Trillium mask, the leak rate was considered acceptable if the upper limit of the 95% CI for the adjusted least squares treatment mean was ≤ 24 L/min.
Time frame: During each approximately 15-day treatment period
Expected Adverse Device Effects
Number of participants with expected adverse device effects during each approximately 15-day mask treatment period. Expected effects included skin effects, oronasal dryness, eye-related side effects, anxiety, allergic reaction, and headache.
Time frame: During each approximately 15-day treatment period
Comfort of Breathing During Mask Use
After each mask treatment period, participants rated their satisfaction with comfort of breathing on a scale from 0 to 10, where 0 indicated extremely dissatisfied, 5 indicated neutral, and 10 indicated extremely satisfied. The reported results are adjusted least squares (LS) means and their 95% confidence intervals. Higher scores indicate greater satisfaction. For the Trillium mask, comfort of breathing satisfaction was considered acceptable if the lower limit of the 95% CI for the least squares treatment mean was ≥ 7.0.
Time frame: At the end of each approximately 15-day treatment period
Apnea-Hypopnea Index (AHI)
Residual apnea-hypopnea index was obtained from PAP device data during each treatment period and expressed as the number of apnea and hypopnea events per hour. The reported results are adjusted least squares (LS) means and their 95% confidence intervals for each mask. Lower values indicate fewer residual respiratory events.
Time frame: During each approximately 15-day mask treatment period
Average Daily PAP Device Use Across All Study Days
Average daily PAP device use was calculated for each participant across all study days in each treatment period, including days with no recorded device use, and expressed in hours per day. The reported results are adjusted least squares (LS) means and their 95% confidence intervals for each mask. Higher values indicate greater device use.
Time frame: During each approximately 15-day treatment period
Epworth Sleepiness Scale Total Score
The Epworth Sleepiness Scale is an 8-item questionnaire assessing the likelihood of dozing during common daily situations. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). Item scores are summed to produce a total score ranging from 0 to 24 points. Higher scores indicate greater daytime sleepiness. The reported results are adjusted least squares (LS) means and their 95% confidence intervals.
Time frame: At the end of each approximately 15-day treatment period
EQ-5D-3L Summary Index
The EQ-5D-3L (European Quality of Life-5D) is a generic measure of health status. The descriptive system assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three response levels (1 = no problems, 2 = some problems, and 3 = extreme problems). Responses were converted to a single summary index using the U.S. value set. Index scores range from -0.109 to 1.000, with higher scores indicating better health status and 1 representing full health. The reported results are adjusted least squares means and their 95% confidence intervals.
Time frame: At the end of each approximately 15-day treatment period
EQ Visual Analog Scale
The EQ visual analog scale records participants' perceived health from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better perceived health. The reported results are adjusted least squares (LS) means and their 95% confidence intervals. No separate acceptance criterion was specified for this measure.
Time frame: At the end of each approximately 15-day treatment period
Single-center study at Florida Lung and Sleep Associates, Fort Myers, Florida, United States. The first participant enrolled on 21 April 2026.
| Milestone | Trillium Mask Followed by AirFit F20 Mask | AirFit F20 Mask Followed by Trillium Mask |
|---|---|---|
| Started | 22 | 23 |
| Completed | 22 | 23 |
| Not completed | 0 | 0 |
Unintentional leak was obtained from positive airway pressure device data during each approximately 15-day mask treatment period. For each participant, the median unintentional leak was calculated. The reported results are adjusted least squares (LS) means of the participant-level median values and their 95% confidence intervals. Lower values indicate less unintentional leak. For the Trillium mask, the leak rate was considered acceptable if the upper limit of the 95% CI for the adjusted least squares treatment mean was ≤ 24 L/min.
| L/min | Trillium | AirFit F20 |
|---|---|---|
| Median Unintentional Leak | 11.01 (5.80 to 16.23) | 6.52 (1.31 to 11.74) |
Number of participants with expected adverse device effects during each approximately 15-day mask treatment period. Expected effects included skin effects, oronasal dryness, eye-related side effects, anxiety, allergic reaction, and headache.
| Participants | Trillium | AirFit F20 |
|---|---|---|
| Expected Adverse Device Effects | 0 | 0 |
After each mask treatment period, participants rated their satisfaction with comfort of breathing on a scale from 0 to 10, where 0 indicated extremely dissatisfied, 5 indicated neutral, and 10 indicated extremely satisfied. The reported results are adjusted least squares (LS) means and their 95% confidence intervals. Higher scores indicate greater satisfaction. For the Trillium mask, comfort of breathing satisfaction was considered acceptable if the lower limit of the 95% CI for the least squares treatment mean was ≥ 7.0.
| points on a 0-10 scale | Trillium | AirFit F20 |
|---|---|---|
| Comfort of Breathing During Mask Use | 8.88 (8.35 to 9.40) | 9.12 (8.59 to 9.64) |
Residual apnea-hypopnea index was obtained from PAP device data during each treatment period and expressed as the number of apnea and hypopnea events per hour. The reported results are adjusted least squares (LS) means and their 95% confidence intervals for each mask. Lower values indicate fewer residual respiratory events.
| events/hour | Trillium | AirFit F20 |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | 2.77 (2.07 to 3.47) | 2.61 (1.91 to 3.31) |
Average daily PAP device use was calculated for each participant across all study days in each treatment period, including days with no recorded device use, and expressed in hours per day. The reported results are adjusted least squares (LS) means and their 95% confidence intervals for each mask. Higher values indicate greater device use.
| hours/day | Trillium | AirFit F20 |
|---|---|---|
| Average Daily PAP Device Use Across All Study Days | 6.96 (6.51 to 7.42) | 7.00 (6.55 to 7.46) |
The Epworth Sleepiness Scale is an 8-item questionnaire assessing the likelihood of dozing during common daily situations. Each item is scored from 0 (would never doze) to 3 (high chance of dozing). Item scores are summed to produce a total score ranging from 0 to 24 points. Higher scores indicate greater daytime sleepiness. The reported results are adjusted least squares (LS) means and their 95% confidence intervals.
| points | Trillium | AirFit F20 |
|---|---|---|
| Epworth Sleepiness Scale Total Score | 5.55 (4.02 to 7.08) | 6.07 (4.54 to 7.60) |
The EQ-5D-3L (European Quality of Life-5D) is a generic measure of health status. The descriptive system assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three response levels (1 = no problems, 2 = some problems, and 3 = extreme problems). Responses were converted to a single summary index using the U.S. value set. Index scores range from -0.109 to 1.000, with higher scores indicating better health status and 1 representing full health. The reported results are adjusted least squares means and their 95% confidence intervals.
| index points | Trillium | AirFit F20 |
|---|---|---|
| EQ-5D-3L Summary Index | 0.84 (0.79 to 0.90) | 0.85 (0.79 to 0.91) |
The EQ visual analog scale records participants' perceived health from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better perceived health. The reported results are adjusted least squares (LS) means and their 95% confidence intervals. No separate acceptance criterion was specified for this measure.
| points on a 0-100 scale | Trillium | AirFit F20 |
|---|---|---|
| EQ Visual Analog Scale | 77.37 (72.31 to 82.43) | 79.58 (74.51 to 84.64) |
Collected over During each approximately 15-day treatment period, assessed at visits 2 and 3.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trillium | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| AirFit F20 | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Age, Continuous(years) | Trillium Mask Followed by AirFit F20 Mask | AirFit F20 Mask Followed by Trillium Mask | Total |
|---|---|---|---|
| Mean | 58.9 ± 12.54 | 58.7 ± 12.23 | 58.8 ± 12.24 |
| Sex: Female, Male(Participants) | Trillium Mask Followed by AirFit F20 Mask | AirFit F20 Mask Followed by Trillium Mask | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 16 | 13 | 29 |
| Race (NIH/OMB)(Participants) | Trillium Mask Followed by AirFit F20 Mask | AirFit F20 Mask Followed by Trillium Mask | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 17 | 20 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Trillium Mask Followed by AirFit F20 Mask | AirFit F20 Mask Followed by Trillium Mask | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 18 |
| Not Hispanic or Latino | 10 | 13 | 23 |
| Unknown or Not Reported | 2 | 2 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2026 to primary completion in May 2026, 1 month.
Results were first posted in Nov 2026, 5 months after primary completion.
Of 116 industry-sponsored interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 1 month is below that.
Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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