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Sleep Apnea: Mechanism and Cerebrovascular Consequences - Article


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Sleep Apnea

Apnea; Apnea, Sleep


Clinical Trial: Sleep Apnea: Mechanism and Cerebrovascular Consequences

This study is not yet open for patient recruitment.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

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 Treatment or Intervention
Stroke
Sleep Apnea, Obstructive
 Drug: acetazolamide

MedlinePlus related topics:  Sleep Apnea;   Stroke

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further Study Details: 

Study start: July 2005;  Expected completion: October 2008

Eligibility

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00108602


Wisconsin
      William Middleton VA Memorial Hospital, Madison,  Wisconsin,  53705,  United States
Marvin Rupp, MA  608-280-7007    marvin.rupp@med.va.gov 
James Skatrud, M.D.,  Principal Investigator

More Information

Study ID Numbers:  0035
Record last reviewed:  April 2005
Last Updated:  April 15, 2005
Record first received:  April 15, 2005
ClinicalTrials.gov Identifier:  NCT00108602
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03


Source: ClinicalTrials.gov
Cache Date: May 4, 2005


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May 13, 2008



Page Updated: May 11, 2006
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