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Sleep Apnea: Mechanism and Cerebrovascular Consequences

Primary Purpose

Sleep Apnea, Obstructive, Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acetazolamide
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring sleep apnea, stroke, ventilatory control

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 15, 2005
    Last Updated
    June 25, 2015
    Sponsor
    US Department of Veterans Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00108602
    Brief Title
    Sleep Apnea: Mechanism and Cerebrovascular Consequences
    Official Title
    Sleep Apnea: Mechanism and Cerebrovascular Consequences
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    This study of the overall grant was not pursued as the aims were changed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    US Department of Veterans Affairs

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea, Obstructive, Stroke
    Keywords
    sleep apnea, stroke, ventilatory control

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Single
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Intervention Type
    Drug
    Intervention Name(s)
    acetazolamide

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven Barczi, MD
    Organizational Affiliation
    Wlliam S. Middleton Memorial Veterans Hospital, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Sleep Apnea: Mechanism and Cerebrovascular Consequences

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