CClinicalTrials.gg
Sign In
Status unknownNCT05669456ZASHUpdated Dec 30, 2022

Zeit Alert for Stroke at Home (ZASH) Protocol

An observational study in Acute Ischemic Stroke, Ischemic Stroke and Stroke, sponsored by Zeit Medical, Inc.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-30.

Sponsored by Zeit Medical, Inc. · Observational

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Acute Ischemic Stroke
  • Ischemic Stroke
  • Stroke

Keywords

  • reoccurring
  • detection
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 300 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Zeit Medical, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population includes subjects who are 18 years of age or older with a new acute ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the primary reason for hospital or clinic presentation during which screening took place.

Inclusion criteria

  1. New ischemic stroke confirmed by neuroimaging (CT or MRI scans) as the reason for current hospital admission or stroke clinics visit. Time from ictus to enrollment should be ≤ 2 weeks;
  2. RRE-90 > 2;
  3. Age ≥ 18 years old;
  4. Patient is discharged to home;
  5. Provision of signed and dated informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Subject is a member of a vulnerable population, such as prisoners, individuals without legal papers, or otherwise exploitable population;
  2. Treatment with another investigational drug or intervention within the last two (2) weeks prior to start of this study, if said drug/intervention is expected to interfere with the normal function of the Halo Alert System;
  3. Does not have WIFI internet access in their home;
  4. Does not have access to a smartphone;
  5. Open traumatic injury on the head;
  6. Allergy to any of the components of the headband, such as the fabric of the band (88% Rayon, 9% Nylon, 3% Spandex), the electrode surfaces (conductive silver ink.)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • DeviceHalo Alert System

    The Halo Alert System consists of an EEG sensor headband and is paired with a data transfer device.

06

What researchers measure

Primary outcomes

  1. Feasibility of Halo Alert System to collect EEG data for algorithm development

    Subject's data collection with the Halo Alert System to assess the feasibility of EEG based stroke detection at home for algorithm development.

    Time frame: 12 months enrollment period

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05669456
Lead sponsor
Zeit Medical, Inc.
Responsible party
Sponsor
First posted
Dec 30, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Jun 30, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Dec 30, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke→

Start the discussion