PRevalence Of Transient Global Amnesia in Obstructive Sle... | NCT06903026

Studies
PRevalence Of Transient Global Amnesia in Obstructive Sleep Apnea Syndrome

NCT06903026

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Mar 30, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Transient Global Amnesia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2023Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2025

Last Update Posted Date

Mar 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D020236	Amnesia, Transient Global
D012891	Sleep Apnea Syndromes

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000647	Amnesia