NCT00108602

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2005

Completed
2 years until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

Same day

First QC Date

April 15, 2005

Last Update Submit

June 25, 2015

Conditions

Sleep Apnea, ObstructiveStroke

Keywords

sleep apneastrokeventilatory control

Study Arms (1)

1

OTHER
Drug: acetazolamide

Interventions

acetazolamideDRUG
1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Hemorrhagic stroke,
  • A history of chronic obstructive lung disease,
  • Left ventricular ejection fraction (LVEF) \<55%
  • Evidence of nasal or pharyngeal obstruction on physical examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, ObstructiveStrokeSleep Apnea Syndromes

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Steven Barczi, MD

    Wlliam S. Middleton Memorial Veterans Hospital, Madison

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

April 15, 2005

First Posted

April 18, 2005

Study Start

May 1, 2007

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

June 26, 2015

Record last verified: 2015-06