Sleep Apnea: Mechanism and Cerebrovascular Consequences
This study has been withdrawn prior to enrollment.
(This study of the overall grant was not pursued as the aims were changed)
Information provided by:
Department of Veterans Affairs
First received: April 15, 2005
Last updated: August 1, 2008
Last verified: August 2008
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.
Sleep Apnea, Obstructive
||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
||Sleep Apnea: Mechanism and Cerebrovascular Consequences
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- We will select non-obese patients (body mass index [BMI] <30 kg/m2) with stroke diagnosed during the 3 previous months and obstructive sleep apnea on screening sleep study (apnea-hypopnea index [AHI] >15 events/hr of study time).
- Patients with stroke will be selected based on the following criteria: 85 years old or less with a history of ischemic stroke within 3 months resulting in mild to moderate neurological impairment (Rankin scale < 3)
- Hemorrhagic stroke,
- A history of chronic obstructive lung disease,
- Left ventricular ejection fraction (LVEF) <55%
- Evidence of nasal or pharyngeal obstruction on physical examination.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00108602
||Steven Barczi, MD
||Wlliam S. Middleton Memorial Veterans Hospital, Madison
No publications provided
||Barczi, Steven - Principal Investigator, Department of Veterans Affairs
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 15, 2005
||August 1, 2008
||United States: Federal Government
Keywords provided by Department of Veterans Affairs:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 04, 2015
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Carbonic Anhydrase Inhibitors
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs