Sleep Apnea: Mechanism and Cerebrovascular Consequences

Stroke Clinical Trial

Official title: Sleep Apnea: Mechanism and Cerebrovascular Consequences

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke

• NCT number: NCT00108602
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Withdrawn
• Phase: N/A
• Start date: May 2007
• Completion date: May 2007