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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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ClinicalTrials.gov Identifier: NCT02522819
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: CPAP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: obstructive sleep apnea in the acute phase of stroke
Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke
Device: CPAP
Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke.




Primary Outcome Measures :
  1. CPAP feasibility [ Time Frame: day 5 ]
    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 :
  1. Feasibility of the ventilatory polygraph [ Time Frame: night 1 ]
    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.

  2. Tolerance of CPAP by patient per night [ Time Frame: 5 nights ]
    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

  3. Number of hypotensive episodes per night per patient [ Time Frame: 5 nights ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522819


Locations
France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Bernard TARDY, PhD CHU Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02522819     History of Changes
Other Study ID Numbers: 1108101
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Obstructive Sleep Apnea Syndrome
acute stroke
apnea-hypopnea index (AHI)

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases