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
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)|
|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|
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
Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke.
- 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.
- 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.
- 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
- 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.
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
|Saint-Etienne, France, 42055|
|Principal Investigator:||Bernard TARDY, PhD||CHU Saint-Etienne|