Smart Mask V1 System for Sleep Apnea

(SSAM Trial)

Not yet recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pathway Medtech, LLC.

Disqualifiers: Pregnancy, Implantable device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Smart Mask, designed to measure sleep stages and disturbances in individuals with sleep apnea. Researchers aim to determine if the Smart Mask can accurately track sleep compared to existing methods. Participants with obstructive sleep apnea who already use a positive air pressure (PAP) machine may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance sleep monitoring technology.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the Smart Mask V1 System is safe for use in sleep studies?

Research shows that the Smart Mask V1 System is undergoing testing to evaluate its effectiveness in measuring sleep stages and disturbances in individuals with sleep apnea. So far, no safety issues or problems have been reported from using the Smart Mask. This device is designed for use with a standard positive air pressure (PAP) machine, a common treatment for sleep apnea. Since the trial is in its early stages, the primary goal is to assess how well the Smart Mask tracks sleep stages compared to other devices.

Although detailed data from earlier studies is not available, early trials typically focus on safety. This generally means the device should be comfortable and safe for participants. The Smart Mask is non-invasive and compatible with existing PAP machines, so it is expected to be safe for most users. However, as with any trial, participants should discuss any potential risks with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Mask V1 System because it offers a fresh approach to diagnosing and managing sleep apnea. Unlike traditional treatments like CPAP machines, which primarily focus on maintaining open airways during sleep, the Smart Mask uses advanced neural network algorithms to accurately detect sleep stages and arousals. This innovative feature not only enhances diagnosis precision but also personalizes sleep apnea therapy, potentially improving patient outcomes and comfort. Additionally, by integrating with cloud-based software, it allows for more accessible and streamlined data analysis, making it a cutting-edge tool in sleep medicine.

What evidence suggests that the Smart Mask is effective for measuring sleep stages and arousals in sleep apnea?

Research has shown that the Smart Mask V1 System, used by participants in this trial, might help track sleep patterns and problems in people with obstructive sleep apnea (OSA). This system employs smart technology to recognize different sleep stages and sudden awakenings. In this trial, researchers will compare the Smart Mask V1 to other devices like EnsoSleep, which the FDA has already approved for similar purposes, to validate its accuracy. The Smart Mask V1 uses sensors to monitor heart rate and breathing, enabling it to detect sleep issues accurately. While more evidence is needed to confirm its effectiveness in treating OSA, early signs suggest it could be important for diagnosing and managing this condition by providing detailed sleep information. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with sleep-disordered breathing, such as obstructive sleep apnea. Participants will undergo an overnight sleep study in a facility. They should not have conditions that could interfere with the use of the Smart Mask or PAP device.

Inclusion Criteria

I am at least 18 years old.

I have sleep-disordered breathing and have been prescribed PAP therapy or referred for a sleep study.

Subjects must be fluent in English

Exclusion Criteria

I cannot or will not wear a PAP mask as required.

Subjects currently employed by, previously employed by or in any way affiliated (consulting, etc.) with any manufacturer or provider of PAP equipment and/or services

Subjects who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I - Training

Participants undergo a one-night, in-lab sleep study while wearing the Smart Mask and WatchPAT, receiving PAP therapy. Data is used to train and refine the Smart Mask's neural network algorithms.

1 night

1 visit (in-person)

Phase II - Validation

Participants undergo a single overnight, in-lab sleep study while wearing the Smart Mask and WatchPAT device, receiving PAP therapy. Data is used to validate the Smart Mask's neural network algorithms.

1 night

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smart Mask V1 System

Trial Overview The trial tests if the Smart Mask can accurately measure sleep stages and arousals against gold-standard polysomnography and EnsoSleep AI device. It uses neural network classifiers to analyze pulse rate and airflow while sleeping.

How Is the Trial Designed?

Group I: Phase II - Validation Experimental Treatment 3 Interventions

Participants in this arm will undergo a single overnight, in-lab sleep study while wearing the Smart Mask and WatchPAT device, while receiving PAP therapy. Standard PSG data will be collected and stored. Data from the Smart Mask will be processed using trained neural networks to detect sleep stages (N1/N2, N3, REM, Wake), arousals, and calculate the Arousal Index. These outputs will be compared to: 1) manual scoring of PSG data by three independent, blinded RPSGTs; and 2) results from the predicate device, EnsoSleep. Data from this phase will be used validate the Smart Mask's neural network algorithms for detecting sleep stages and arousals.

Group II: Phase I - Training Experimental Treatment 3 Interventions

Participants in this arm will undergo a one-night, in-lab sleep study while wearing the Smart Mask and WatchPAT while receiving positive airway pressure ('PAP') therapy. Standard polysomnography ('PSG') data will be collected and stored. Three independent registered PSG technologists ('RPSGTs') will manually score the data to estimate sleep stages and arousals, following the guidelines in 'The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications', which is the definitive reference for the scoring of PSG and HSATs. PSG data will also be uploaded to EnsoSleep's cloud-based software system. Data from this phase will be used solely to train and refine the Smart Mask's neural network algorithms for detecting sleep stages and arousals. No algorithm validation will occur in this phase.

Who Is Running the Clinical Trial?

Pathway Medtech, LLC.

Lead Sponsor

Citations

1. patlynk.com patlynk.com/trial/NCT07136272

SSAM | Smart Mask System for Sleep Disorder Detection in ... This clinical study aims to validate a new system called the Smart Mask V1 System (SSAM) designed to monitor sleep stages and disturbances.

2. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/sleep-apnea

Sleep Apnea clinical trials at University of California Health The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39833613/

Validation of a novel mask-based device for monitoring ... Purpose: This study aimed to validate the new DormoTech Vlab device's performance, usability, and validity as a sleep test and physiological ...

4. cell.com cell.com/cms/10.1016/j.matt.2025.102323/attachment/e67c610d-391a-4503-b507-febb8b3ee162/mmc4.pdf

A wearable all-in-one obstructive sleep apnea ... As a result, this system achieves apnea relief through precise recognition of the apnea by the sensing unit and effective intervention via the.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04011826

The Evaluation of a New Nasal Mask for the Treatment ... This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03552133

Variable Dead Space Rebreathing Device to Treat Sleep ... The purpose of this pilot study is to determine the feasibility of using a novel treatment for sleep apnea in which the patient's own exhaled CO2 is tightly ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40671318/

Developing Custom-Fit CPAP Mask Prototype in Patients ... This study explores the feasibility of developing a fully customised CPAP mask prototype using accessible 3D scanning, computer-aided design, and 3D printing ...