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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Median Unintentional Leak During Trillium Mask Use
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- 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)
- 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
研究组 & 干预措施
Trillium then AirFit F20 sequence
Participants will use Trillium for the first treatment period and AirFit F20 for the second treatment period
干预措施: Trillium Full Face Mask (Device)
Airfit F20 then Trillium sequence
Participants will use AirFit F20 for the first treatment period and Trillium for the second treatment period
干预措施: AirFit F20 (Device)
方案终点
主要结局
Median Unintentional Leak During Trillium Mask Use
时间窗: 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.
次要结局
未报告次要终点
试验结果
结果已于 2026-09-28 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看
受试者流程
入组 40 人 · 完成 38 人
主要终点
Median Unintentional Leak During Trillium Mask Use
L/min · 95% Confidence Interval · 时间窗: During the approximately 15-day Trillium mask treatment period
| Trillium （n=38） |
|---|
| 12.14 (5.10–19.19) |
其他终点（6）
Expected Adverse Device Effects
Participants · 时间窗: Approximately 15-day Trillium mask treatment period
| Trillium （n=39） |
|---|
| 0 |
One participant in the AirFit F20-Trillium sequence discontinued prior to Visit 2 and, therefore, was not exposed to the second treatment in their randomized sequence (i.e., Trillium). At the participant level, the subject was included in the safety population. However, at the treatment level, the participant was included for the treatment to which they were exposed. As a result, the number of participants exposed to Trillium was 39.
Comfort of Breathing During Trillium Mask Use
points on a 0-10 scale · 95% Confidence Interval · 时间窗: After approximately 15-day Trillium mask treatment period
| Trillium （n=38） |
|---|
| 9.03 (8.44–9.61) |
Average Daily PAP Device Use Across All Study Days
hours/day · 95% Confidence Interval · 时间窗: During each approximately 15-day mask treatment period
| Trillium （n=38） | AirFit F20 （n=38） |
|---|---|
| 6.62 (6.13–7.11) | 6.57 (6.07–7.06) |
Mean Difference (Final Values) 0.05 · 95% 置信区间 -0.31–0.41
Apnea-Hypopnea Index (AHI)
events/hour · 95% Confidence Interval · 时间窗: During each approximately 15-day mask treatment period
| Trillium （n=38） | AirFit F20 （n=38） |
|---|---|
| 2.28 (1.47–3.08) | 2.41 (1.30–3.51) |
Mean Difference (Final Values) -0.13 · 95% 置信区间 -0.66–0.40
Epworth Sleepiness Scale Total Score
points on a 0-24 scale · 95% Confidence Interval · 时间窗: After each approximately 15-day mask treatment period
| Trillium （n=38） | AirFit F20 （n=38） |
|---|---|
| 5.50 (4.07–6.93) | 5.92 (4.58–7.27) |
Mean Difference (Final Values) -0.42 · 95% 置信区间 -1.65–0.81
EQ-5D-3L Summary Index
EQ-5D-3L index points · 95% Confidence Interval · 时间窗: After each approximately 15-day mask treatment period
| Trillium （n=38） | AirFit F20 （n=38） |
|---|---|
| 0.88 (0.81–0.94) | 0.89 (0.83–0.94) |
Mean Difference (Final Values) -0.01 · 95% 置信区间 -0.04–0.02
安全性
| 组别 | 严重不良事件 | 死亡 |
|---|---|---|
| Trillium | 1 / 39 | 0 / 39 |
| AirFit F20 | 0 / 39 | 0 / 39 |
最常见的严重不良事件（人数）
| 事件 | Trillium | AirFit F20 |
|---|---|---|
| Bilateral lower extremity weakness | 1 / 39 | 0 / 39 |
数值为申办方在 ClinicalTrials.gov 公示的原始数据，未经重新计算；括号内为公示的离散度（如 95% 置信区间）。
研究者
标识符
- NCT 编号
- NCT06932055
- 其他研究编号
- SRC-301124-Trillium Pilot
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 是