Status:
COMPLETED
Autonomic Function in Obstructive Sleep Apnea
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.
Detailed Description
The purpose of this study is to determine if obstructive sleep apnea (OSA)-a condition in which respiration and oxygenation are affected during sleep-can cause abnormal autonomic function and blood su...
Eligibility Criteria
Inclusion
- Age 21-80.
- BMI between 25 and 35.
- Symptoms strongly indicative of sleep apnea (loud snoring, witnessed apneas or history of OSA based on laboratory PSG within 3 months of screening, not currently using CPAP, oral appliances or other treatments for OSA)
Exclusion
- History of previous treatment for OSA.
- History of diabetes.
- History of other disorders known to affect autonomic function (e.g. Parkinson's disease, peripheral neuropathy of any cause, or requiring medications known to affect autonomic function that cannot be stopped safely for 48 hours).
- No evidence of peripheral neuropathy on examination, negative laboratory tests for common causes of neuropathy (B12, Thyroid stimulating hormone, serum protein electrophoresis).
- Inability to cooperate with testing, or to undergo testing (individuals with irregular heart rhythms, significant lung disease, previous LASIK procedure, unable to stop hypertensive medications for 48 hours).
- Medications affecting glucose levels, hypoglycemic agents, high dose thiazide diuretics, beta blocking agents.
- Pregnant or lactating females.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00681161
Start Date
March 1 2006
End Date
December 1 2012
Last Update
February 24 2017
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232