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

Feasibility Evaluation of Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: CPAP

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	night 1
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	5 nights
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.	5 nights

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Bernard TARDY, PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: August 12, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 12, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea Syndrome; acute stroke; apnea-hypopnea index (AHI)
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 1108101