PRevalence Of Transient Global Amnesia in Obstructive Sleep Apnea Syndrome (PROTOS)

March 24, 2025 updated by: University Hospital, Strasbourg, France
Amnesic stroke is an amnestic syndrome lasting less than 24 hours characterized by the occurrence of anterograde amnesia often associated with retrograde amnesia, the pathophysiology of which is still poorly understood at present. A recent study on a small sample size (N=29) highlighted an association between obstructive sleep apnea syndrome and amnesic stroke. Our study seeks to confirm or refute these results on a larger cohort (N=200-250). A better understanding of the pathophysiological processes involved would open up new therapeutic avenues.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Neurologie - CHU de Strasbourg - France
        • Sub-Investigator:
          • Erik SAULEAU, Statistician
        • Contact:
        • Principal Investigator:
          • Benjamin CRETIN, MD
        • Sub-Investigator:
          • Elisabeth RUPPERT, MD
        • Principal Investigator:
          • Solène CHARBONNIER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients seen for consultation in the Neuropsychology Department of Strasbourg University Hospital between March 1, 2015 and December 31, 2021 following an episode of amnestic stroke meeting the Hodges and Warlow criteria.

Description

Inclusion Criteria:

  • Adult patients seen for consultation in the Neuropsychology Department of Strasbourg University Hospital between March 1, 2015 and December 31, 2021 following an episode of amnestic stroke meeting the Hodges and Warlow criteria:
  • The stroke must have been documented and reported by a competent witness present during the stroke.
  • Anterograde amnesia during the stroke.
  • Absence of vigilance, personality, and cognitive disorders other than memory disorders (aphasia, apraxia, etc.).
  • Absence of focal neurological symptoms during the episode and its aftermath.
  • Absence of epileptic manifestations.
  • Resolution of the episode in less than 24 hours.
  • Exclusion of patients with a history of recent head trauma or active epilepsy (undergoing regular treatment or having experienced a seizure in the last 2 years).
  • Subjects who have not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria:

  • Patients who have expressed opposition to the retrospective reuse of their data for scientific research purposes.
  • Patients with active epilepsy
  • Patients with recent head trauma
  • Patients with an MMS < or equal to 25
  • Subject under guardianship or curatorship
  • Subject under judicial protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the prevalence of obstructive sleep apnea syndrome in patients who have experienced an amnestic stroke.
Time Frame: Within the last 2 years
Presence or absence of obstructive sleep apnea syndrome reported by a witness present during the stroke.
Within the last 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8781

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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