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Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test

NCT06224972 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2024-01-25

No results posted yet for this study

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

Conditions

  • Sleep Disorder

Interventions

DEVICE

Vlab

The study is observational, there is no intervention.

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    collaborator OTHER_GOV

  • Dormotech Medical

    lead INDUSTRY

Principal Investigators

  • Benjamin D Fox, MD · Assaf-Harofeh Medical Center

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2023-08-12
Completion
2023-08-12
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06224972 on ClinicalTrials.gov