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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00108602
First Posted: April 18, 2005
Last Update Posted: June 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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: Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Sleep Apnea: Mechanism and Cerebrovascular Consequences

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Enrollment: 0
Study Start Date: May 2007
Study Completion Date: May 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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): NCT00108602


Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Steven Barczi, MD Wlliam S. Middleton Memorial Veterans Hospital, Madison
  More Information

Responsible Party: Barczi, Steven - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108602     History of Changes
Other Study ID Numbers: RESP-017-03S
First Submitted: April 15, 2005
First Posted: April 18, 2005
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by VA Office of Research and Development:
sleep apnea
stroke
ventilatory control

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs