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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108602
First received: April 15, 2005
Last updated: August 1, 2008
Last verified: August 2008

April 15, 2005
August 1, 2008
May 2007
May 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00108602 on ClinicalTrials.gov Archive Site
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Sleep Apnea: Mechanism and Cerebrovascular Consequences
Sleep Apnea: Mechanism and Cerebrovascular Consequences

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
  • Sleep Apnea, Obstructive
  • Stroke
Drug: acetazolamide
1
Intervention: Drug: acetazolamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00108602
RESP-017-03S
Not Provided
Barczi, Steven - Principal Investigator, Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Steven Barczi, MD Wlliam S. Middleton Memorial Veterans Hospital, Madison
Department of Veterans Affairs
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP