Autonomic Function in Obstructive Sleep Apnea (OSA)
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| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Obstructive Sleep Apnea |
| Purpose: |
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The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic
dysfunction independent of its effects on hyperglycemia.
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| Study Summary: |
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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 sugar (glucose) processing, which could lead to diabetes, or pre-diabetic
conditions. The autonomic system controls heart rate, blood pressure, breathing, and other
functions of the body. OSA and diabetes are commonly found in overweight individuals and
both can cause increased risk of heart disease and strokes. OSA can be treated using nasal
continuous positive airway pressure (CPAP) which overcomes the obstruction to airflow that
occurs in OSA.
In this study, the scientists hope to determine if individuals with OSA have an increased
prevalence of undiagnosed diabetes or pre-diabetic conditions, and if autonomic
abnormalities observed previously in OSA are more severe or more common in people with OSA
and diabetes or pre-diabetic conditions.
Participants will undergo a sleep study and glucose studies to determine if they have sleep
apnea and impaired fasting glucose, impaired glucose tolerance, or undiagnosed diabetes
(collectively called impaired glucose regulation).
Individuals with sleep apnea with and without glucose abnormalities will be age and BMI
matched, and will undergo further autonomic and peripheral nerve testing. Individuals
without diabetes will be followed for one year of CPAP treatment for their sleep apnea—with
visits at 3 month intervals to evaluate glucose and autonomic function. Individuals without
sleep apnea or diabetes will also undergo autonomic and peripheral nerve testing.
Participants will also complete questionnaires to assess their sleepiness and symptoms of
autonomic function.
Results from this study will help researchers determine if abnormalities of autonomic
function seen in people with OSA are caused by OSA or by coexistent impaired glucose
regulation present in people with OSA. In addition, results from the study will show if
CPAP treatment improves autonomic dysfunction by correcting breathing abnormalities, or by
secondary improvement of glucose regulation.
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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.
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| NCT ID: |
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NCT00681161 |
| Primary Contact: |
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Principal Investigator
Amanda C. Peltier, MD, MS
Vanderbilt University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Nashville, Tennessee 37232
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 17, 2013 |
| Modifications to this listing: |
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