Autonomic Function in Obstructive Sleep Apnea

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00681161
Study type	Interventional
Source	Vanderbilt University Medical Center
Contact
Status	Completed
Phase	N/A
Start date	March 2006
Completion date	December 2012

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.