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NCT04920175
Real-time State of Vigilance Monitor for the Neonatal Intensive Care Unit
trial testing Novel Real-time Neonatal Sleep Stage Detection Algorithm in Sleep Disturbance in Infancy (Disorder) in 39 participants. Completed in 19 December 2024.
19 December 2024
Quick facts
| Lead sponsor | University of Michigan |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 39 |
| Start date | 1 September 2021 |
| Primary completion | 19 December 2024 |
| Estimated completion | 19 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Novel Real-time Neonatal Sleep Stage Detection Algorithm
Conditions studied
- Sleep Disturbance in Infancy (Disorder) — all drugs for Sleep Disturbance in Infancy (Disorder) →
- Neonatal Disease — all drugs for Neonatal Disease →
Sponsor
University of Michigan
Who can join
Adults 1 Day to 1, any sex, with Sleep Disturbance in Infancy (Disorder) or Neonatal Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to collect data to develop a complete package (hardware, user interface software and algorithms) that can monitor sleep-wake stages in neonates. Real-time EEG data will be used to develop and refine the prototype monitor's ability to provide direct real-time information about sleep-wake state. The study design includes multiple iterative training/testing stages to refine the prototype. The study is divided into multiple sub-aims conducted in parallel: data acquisition, algorithm development (including comparison between gold-standard polysomnogram vs. novel algorithm markings of sleep-stages), and graphical user interface software development. The data acquisition and algorithm development are iterative and linked, such that the prototype algorithm from one iteration will be deployed real-time during the next iteration of data acquisition. This allows verification that the algorithm can perform real-time and provides prospective testing data, which is later folded into the training data for the next iteration, for verification and validation of the system.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04920175
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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 NCT04920175 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Michigan
- Last refreshed: 24 January 2025
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/NCT04920175.
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