NCT04801069

Brief Summary

Sleep Apnea Syndrome (SAS) is highly prevalent in acute stroke and it is related to worst outcome. We aim to assess if SAS treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 5, 2021

Last Update Submit

March 16, 2021

Conditions

Ischemic StrokeSleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

  • Infarct progression

    Ischemic size at 7 days compared to ischemic size at admission on brain MRI

    7 days

Secondary Outcomes (10)

  • Neurological outcome

    3 months

  • Neurological outcome on NIHSS

    3 months

  • Duration of Auto-adaptative Servo-Ventilation use

    7 days

  • SAS prevalence

    3 months

  • SAS severity

    3 months

  • +5 more secondary outcomes

Study Arms (2)

Auto-Adaptative Servo-Ventilation

EXPERIMENTAL
Device: Nocturnal Ventilation

Control

NO INTERVENTION

Interventions

Nocturnal VentilationDEVICE

AirCurve 10CS PaceWave (Resmed)

Auto-Adaptative Servo-Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute ischemic stroke on brain MRI
  • NIHSS 6-22
  • thrombolysis

You may not qualify if:

  • Previous SAS
  • Previous stroke
  • Auto-adaptative Servo-Ventilation Contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meseguer

Paris, 75018, France

Location

MeSH Terms

Conditions

Ischemic StrokeSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Elena Meseguer, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Meseguer, MD

CONTACT

01 40 25 74 86elena.meseguer@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 16, 2021

Study Start

March 15, 2021

Primary Completion

March 15, 2023

Study Completion

September 15, 2023

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)