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Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, acute stroke, apnea-hypopnea index (AHI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - Clinical presentation of ischemic stroke confirmed by imaging (CT or MRI brain scan)
  • less than 24 hours from onset of symptoms
  • admitted to the Neurovascular unit of the Emergency Hospitalisation Department of 'Hôpital Nord' of the university hospital of Saint-Étienne
  • presenting obstructive sleep apnea syndrome (defined as an apnea-hypopnea index (AHI) of ≥ 10 and > 50% of obstructive events)
  • written consent of patient

Exclusion Criteria:

  • Concussion (Coma Glasgow Score <12)
  • Comprehension aphasia
  • Uncontrollable confusion and agitation
  • History of dementia
  • History of ischemic stroke with neurological damage
  • History of hemorrhagic stroke
  • History of epilepsy
  • Cerebrospinal fluid leak, recent cranial surgery or head injury
  • Serious bullous lung disease
  • Hypoxic pulmonary disease
  • Pleurisy or pneumothorax requiring draining
  • Respiratory distress requiring mechanical ventilation
  • Oxygen therapy prior to stroke
  • Non-invasive ventilation therapy prior to stroke
  • Hypotension
  • Dehydration
  • Hypersalivation
  • Vomiting
  • Pregnancy, parturients, breast feeding
  • Absence of consent

Sites / Locations

  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

obstructive sleep apnea in the acute phase of stroke

Arm Description

Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke

Outcomes

Primary Outcome Measures

CPAP feasibility
Number of patients for which CPAP is used for a minimum of 3 hours per night over 5 nights. CPAP feasibility is retained if at least 50% of all patients have had the use of CPAP for at least 3 hours per night over 5 nights.

Secondary Outcome Measures

Feasibility of the ventilatory polygraph
Number of readable polygraph recordings. A readable recording is defined as a minimum duration of 6 hours of recording with signals of a sufficient quality.
Tolerance of CPAP by patient per night
Evaluation of CPAP tolerance according to a score as per the VAS (Visual Analogue Scale) for pain ranging from 0: "No tolerance" to 10: "Excellent tolerance" per night of use of CPAP device
Number of hypotensive episodes per night per patient
Number of hypotensive episodes per night per patient by non-invasive measuring of blood pressure during the period of use of the CPAP device and defined according to systolic BP of < 90 mm Hg or drop of 40 mmHg with respect to the basic parameter.

Full Information

First Posted
August 12, 2015
Last Updated
August 12, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02522819
Brief Title
Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke
Official Title
Feasibility Evaluation of Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea. Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population. Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Obstructive Sleep Apnea Syndrome, acute stroke, apnea-hypopnea index (AHI)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obstructive sleep apnea in the acute phase of stroke
Arm Type
Experimental
Arm Description
Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke.
Primary Outcome Measure Information:
Title
CPAP feasibility
Description
Number of patients for which CPAP is used for a minimum of 3 hours per night over 5 nights. CPAP feasibility is retained if at least 50% of all patients have had the use of CPAP for at least 3 hours per night over 5 nights.
Time Frame
day 5
Secondary Outcome Measure Information:
Title
Feasibility of the ventilatory polygraph
Description
Number of readable polygraph recordings. A readable recording is defined as a minimum duration of 6 hours of recording with signals of a sufficient quality.
Time Frame
night 1
Title
Tolerance of CPAP by patient per night
Description
Evaluation of CPAP tolerance according to a score as per the VAS (Visual Analogue Scale) for pain ranging from 0: "No tolerance" to 10: "Excellent tolerance" per night of use of CPAP device
Time Frame
5 nights
Title
Number of hypotensive episodes per night per patient
Description
Number of hypotensive episodes per night per patient by non-invasive measuring of blood pressure during the period of use of the CPAP device and defined according to systolic BP of < 90 mm Hg or drop of 40 mmHg with respect to the basic parameter.
Time Frame
5 nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Clinical presentation of ischemic stroke confirmed by imaging (CT or MRI brain scan) less than 24 hours from onset of symptoms admitted to the Neurovascular unit of the Emergency Hospitalisation Department of 'Hôpital Nord' of the university hospital of Saint-Étienne presenting obstructive sleep apnea syndrome (defined as an apnea-hypopnea index (AHI) of ≥ 10 and > 50% of obstructive events) written consent of patient Exclusion Criteria: Concussion (Coma Glasgow Score <12) Comprehension aphasia Uncontrollable confusion and agitation History of dementia History of ischemic stroke with neurological damage History of hemorrhagic stroke History of epilepsy Cerebrospinal fluid leak, recent cranial surgery or head injury Serious bullous lung disease Hypoxic pulmonary disease Pleurisy or pneumothorax requiring draining Respiratory distress requiring mechanical ventilation Oxygen therapy prior to stroke Non-invasive ventilation therapy prior to stroke Hypotension Dehydration Hypersalivation Vomiting Pregnancy, parturients, breast feeding Absence of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard TARDY, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

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Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke

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