Sleep Apnea: Mechanism and Cerebrovascular Consequences
This study will determine the effect of ventilatory stimulation on obstructive sleep apnea in selected patients with stroke. We will select a subset of patients with stroke in the prior 3 months who are most likely to have ventilatory instability as a cause of the upper airway obstruction as indicated by the absence of obesity, an abnormal hypocapnic apnea threshold and resolution of obstructive apnea during CO2 administration. Following baseline polysomnography, patients will be randomly assigned to acetazolamide (250 mg hs [at bedtime]) versus placebo for 7 days. Polysomnography will be repeated and then subjects will cross-over therapies for another 7 days followed by a final nocturnal polysomnography.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
|Official Title:||Sleep Apnea: Mechanism and Cerebrovascular Consequences|
|Study Start Date:||May 2007|
|Estimated Study Completion Date:||May 2007|
|Estimated Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
This study never enrolled patients. It was a component of a larger VA Merit grant and the other aims of the grant were completed but due to logistic issues and recruitment challenges this particular protocol was never made active.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108602
|Principal Investigator:||Steven Barczi, MD||Wlliam S. Middleton Memorial Veterans Hospital, Madison|