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NCT06224972
Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test
trial testing Vlab in Sleep Disorder in 47 participants. Completed in 12 August 2023.
12 August 2023
Quick facts
| Lead sponsor | Dormotech Medical |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 47 |
| Start date | 13 June 2023 |
| Primary completion | 12 August 2023 |
| Estimated completion | 12 August 2023 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Vlab
Conditions studied
- Sleep Disorder — all drugs for Sleep Disorder →
Sponsor
Dormotech Medical
Who can join
22 and older, any sex, with Sleep Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Validation of a novel mask-based device for monitoring of comprehensive sleep parameters and sleep disordered breathing.
Fox BD, Shihab M, Nassir A, Kushinsky D, et al · · 2025 · PMID 39833613 · DOI 10.1007/s11325-025-03250-1
Verify or expand the search:
- PubMed search for NCT06224972
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Dormotech Medical trials
Trials by the same sponsor.
- NCT06516809 — The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06224972 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dormotech Medical
- Last refreshed: 25 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06224972.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing