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

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522819
• Other study ID #: 1108101
• Status: Completed
• Phase: N/A
• First received: August 12, 2015
• Last updated: August 12, 2015
• Start date: October 2011
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes