Usability and Performance Assessment of DormoTech VLAB
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- AHI Score and Classification
Study Overview
Brief Summary
The study is a comparative, self-controlled, randomized, prospective investigation designed to assess the usability and accuracy of the DormoTech Vlab and compare its performance with a full polysomnography (PSG) study conducted over one night in a sleep lab. For the purpose of this study, the selected PSG device used for comparison is the Nox A1 system (K192469). Participants were required to wear the DormoTech Vlab, answer questionnaires pre and post-study, and simultaneously undergo a full PSG test using the Nox system.
The statistical methodology for this study was designed to ensure a comprehensive analysis of the data, adhering to the standards set by the International Council for Harmonisation (ICH) E3 guideline
Detailed Description
The intended use of the V-Lab device is to serve as Type 2 Sleep test, an inexpensive, more comfortable device that can replace the full sleep study in a sleep lab and at-home environment.
The device is composed of three units, two of which are wearable and the third is a central unit responsible for communication; The head unit is worn on the face like a mask, and the body unit is a belt that is worn around the torso. After a few minutes of wearing the device, the patient will become ignorant of its presence. A small rechargeable 3V Li-ion battery operates both units.
The V-Lab system supports the connectivity of peripheral devices for capturing additional signals using Bluetooth technology, e.g. pulse oximeters. The V-Lab device collects and stores physiological signals such as EEG, EOG, EMG, Total Airflow, Snore, Respiratory Effort (Thoracic and Abdominal), Body and Head Position, and HR (derived from Plethysmography) Both the head and chest units communicate with the central units via Bluetooth, and the wearable units send the measured data to the central unit. The central unit receives the data, stores it within an internal flash drive, and transmits it via Wi-Fi to online servers for further diagnosis.
Using the recorded data, a physician can diagnose sleep disorders manually or use any sleep diagnostic system that supports EDF Formats.
The study Objectives are to assess the efficiency, usability, durability, safety, and patient satisfaction of the V-Lab device and to validate the level of agreement between the V-Lab device and a PSG.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
AHI Score and Classification
Time Frame: During night 1
The AHI (apnea-hypopnea index) score was categorized and compared according to levels of severity: AHI = number of Apneas+Hypopneas/total sleep time Categorizing Normal \<5, Mild: 5\<AHI\<15, Moderate: 15\<AHI\<30, Severe: 30\<AHI
Secondary Outcomes
- Sleep Efficiency (%)(During night 1)
- Sleep Stages (%)(During night 1)
- REM Latency (min)(During night 1)
- Total snore (%)(During night 1)
- Body Position(During night 1)
- Total Sleep Time (min)(During night 1)
- Sleep Latency (min)(During night 1)
- Wake After Sleep Onset (min)(During night 1)