Working… Menu

Sleep Apnea: Mechanism and Cerebrovascular Consequences

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. Identifier: NCT00108602
Recruitment Status : Withdrawn (This study of the overall grant was not pursued as the aims were changed)
First Posted : April 18, 2005
Last Update Posted : June 26, 2015
Information provided by:
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Stroke Drug: acetazolamide Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Sleep Apnea: Mechanism and Cerebrovascular Consequences
Study Start Date : May 2007
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
1 Drug: acetazolamide

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00108602

Sponsors and Collaborators
US Department of Veterans Affairs
Layout table for investigator information
Principal Investigator: Steven Barczi, MD Wlliam S. Middleton Memorial Veterans Hospital, Madison

Layout table for additonal information
Responsible Party: Barczi, Steven - Principal Investigator, Department of Veterans Affairs Identifier: NCT00108602     History of Changes
Other Study ID Numbers: RESP-017-03S
First Posted: April 18, 2005    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by VA Office of Research and Development:
sleep apnea
ventilatory control
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs