Sleep Apnea: Mechanism and Cerebrovascular Consequences

NCT ID: NCT00108602

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-05-31

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.

Conditions

Sleep Apnea, Obstructive; Stroke

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

Group Type: OTHER

acetazolamide

Intervention Type: DRUG

Interventions

acetazolamide

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Department of Veterans Affairs

Principal Investigators

Steven Barczi, MD

Role: PRINCIPAL_INVESTIGATOR

Wlliam S. Middleton Memorial Veterans Hospital, Madison

Other Identifiers

RESP-017-03S

Identifier Type: -

Identifier Source: org_study_id