Sleep Apnea: Mechanism and Cerebrovascular Consequences
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Apnea, Obstructive Stroke |
Drug: acetazolamide |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | Sleep Apnea: Mechanism and Cerebrovascular Consequences |
| Estimated Enrollment: | 0 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| 1 | Drug: acetazolamide |
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Hemorrhagic stroke,
- A history of chronic obstructive lung disease,
- Left ventricular ejection fraction (LVEF) <55%
- Evidence of nasal or pharyngeal obstruction on physical examination.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Barczi, Steven - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108602 History of Changes |
| Other Study ID Numbers: | RESP-017-03S |
| Study First Received: | April 15, 2005 |
| Last Updated: | August 1, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
sleep apnea stroke ventilatory control |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Stroke Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Acetazolamide Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013