NCT01561677

Brief Summary

Obstructive Sleep Apnea Syndrome (OSAS) is associated with stroke as a risk factor but little is known about the consequences of OSAS on the outcome and the survival after stroke. The aim of the investigators study is first to evaluate the outcome and the survival of patients with stroke depending of OSAS (presence and severity of OSAS) and second to compare the outcome and survival of patients with severe OSAS depending on the treatment of the syndrome with nocturnal continuous positive airway pressure. The investigators hypothesis is that OSAS is associated with worst survival and outcome and needs to be treated at the subacute phase of stroke.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 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

Study Start

First participant enrolled

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

7.5 years

First QC Date

March 6, 2012

Last Update Submit

June 7, 2018

Conditions

Obstructive Sleep Apnea SyndromeBrain Infarction

Keywords

obstructive sleep apneasyndrome survivalischemic strokecontinuous positive airway pressurehandicap

Outcome Measures

Primary Outcomes (1)

  • functional independence scale

    The variation of the functional independence scale is evaluated by the Barthel Index at three months after stroke in four groups of patients depending on their apnea/hypopnea.In the patients group severe OSAS treated with CPAP from day 15 after stroke compared to patients with severe OSAS treated with sham CPAPThe neurological dependency will be evaluated by the Barthel Index .This scale measures the consequences of the motor and cognitive disorders on the daily living with 10 items.

    3 months

Secondary Outcomes (5)

  • neurological impairment

    3 months

  • the handicap

    3 months

  • blood pressure

    3 months

  • the quality of life

    3 months

  • the survival

    3 months

Study Arms (5)

apnea/hypopnea index (AHI<5 : no OSAS)

NO INTERVENTION

apnea/hypopnea index (5≥AHI<15 : mild OSAS)

NO INTERVENTION

apnea/hypopnea index (15≤AHI<30 :moderate OSAS)

NO INTERVENTION

apnea/hypopnea index ( AHI≥30 : severe OSAS treated).

ACTIVE COMPARATOR

Treated with CPAP

Device: Continuous Positive Airway pressure-RESPIRONICS

apnea/hypopnea index ( AHI≥30:severe OSAS untreated).

SHAM COMPARATOR

Treated with sham CPAP (placebo)

Device: Sham Continuous Positive Airway pressure-RESPIRONICS

Interventions

Continuous Positive Airway pressure-RESPIRONICSDEVICE

obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap

apnea/hypopnea index ( AHI≥30 : severe OSAS treated).
Sham Continuous Positive Airway pressure-RESPIRONICSDEVICE

inefficient Continuous Positivie Airway pressure

apnea/hypopnea index ( AHI≥30:severe OSAS untreated).

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Brain infarction confirmed by brain imaging
  • follow up possible
  • Severity at admission and at one week follow up:
  • NIHSS ≥ 4 or- isolated aphasia (item 9 ofNIHSS ≥ 1) or
  • negligence (item 11 du NIHSS ≥ 2) or
  • distal motor deficit (score ≥ 1)
  • Health insurance affiliation
  • Inform and free consent agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

RECRUITING

Related Publications (1)

  • Denis C, Jaussent I, Guiraud L, Mestejanot C, Arquizan C, Mourand I, Chenini S, Abril B, Wacongne A, Tamisier R, Baillieul S, Pepin JL, Barateau L, Dauvilliers Y. Functional recovery after ischemic stroke: Impact of different sleep health parameters. J Sleep Res. 2024 Feb;33(1):e13964. doi: 10.1111/jsr.13964. Epub 2023 Jun 20.

    PMID: 37338010DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveBrain InfarctionIschemic Stroke

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Yves DAUVILLIERS, MD-PhD

CONTACT

y-dauvilliers@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 23, 2012

Study Start

September 1, 2011

Primary Completion

March 1, 2019

Study Completion

December 1, 2020

Last Updated

June 11, 2018

Record last verified: 2018-06

Locations

FR(1)