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Zeit Alert for Stroke at Home (ZASH) Protocol — ZASH  

Stroke Clinical Trial

Official title:
Zeit Alert for Stroke at Home (ZASH) Protocol

Clinical Trial Summary

This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight.

Clinical Trial Description

This is a single-arm, observational, feasibility study to evaluate if the Halo Alert System can be used in the future to detect stroke events in individuals at risk for stroke wearing the Halo Alert System overnight. The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device. Approximately 300 subjects with elevated stroke risk will be enrolled and followed for a duration of 90 days. The EEG tracing for each study subject will be labeled after study conclusion with the help of clinically available information on the occurrence of a recurrent stroke. The labeled data will then be used to further develop the existing (operating room based) stroke detection algorithm and adjust the algorithm for outpatient use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05669456
Study type Observational
Source Zeit Medical, Inc.
Contact
Status Not yet recruiting
Phase
Start date January 1, 2023
Completion date September 30, 2024
View Details
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