Sleep Apnea: Mechanism and Cerebrovascular Consequences

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT00108602

Collaborator

(none)

Enrollment

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Stroke	Drug: acetazolamide	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Intervention Model:

Crossover Assignment

Masking:

Single

Primary Purpose:

Diagnostic

Official Title:

Sleep Apnea: Mechanism and Cerebrovascular Consequences

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: 1	Drug: acetazolamide

Arm

Intervention/Treatment

Other: 1

Drug: acetazolamide

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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)