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

NCT02522819 | Completed

• 1 other identifier: 1108101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome; acute stroke; apnea-hypopnea index (AHI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Feasibility of the ventilatory polygraph

  night 1

• Tolerance of CPAP by patient per night

  5 nights

• Number of hypotensive episodes per night per patient

  5 nights

Study Arms (1)

obstructive sleep apnea in the acute phase of stroke

EXPERIMENTAL

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

Device: CPAP

Interventions

CPAP DEVICE

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

obstructive sleep apnea in the acute phase of stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Stroke

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bernard TARDY, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 13, 2015
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

FR (1)