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Sponsors and Collaborators: |
Vanderbilt University National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00681161 |
The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.
Condition | Intervention |
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Obstructive Sleep Apnea |
Other: continuous positive airway pressure (CPAP) |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
Official Title: | Autonomic Function in Obstructive Sleep Apnea (OSA) |
Estimated Enrollment: | 90 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A |
Other: continuous positive airway pressure (CPAP)
Standard of care treatment for OSA, requires a mask attached by tubing to a device providing continuous pressure of air at a given cm of water pressure, acting as a splint to open airway at night to relieve obstruction.
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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. 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.
Ages Eligible for Study: | 21 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amanda C. Peltier, MD, MS | 615-936-8444 | Amanda.peltier@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Amanda C. Peltier, MD, MS 615-936-8444 amanda.peltier@vanderbilt.edu |
Principal Investigator: | Amanda C. Peltier, MD, MS | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Amanda C. Peltier, MD MS/ Assistant Professor Neurology ) |
Study ID Numbers: | K23NS056009, 1K23 NS056009-01A1 |
Study First Received: | May 19, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00681161 |
Health Authority: | United States: Federal Government |
obstructive sleep apnea OSA diabetes pre-diabetic condition |
obesity blood glucose continuous positive airway pressure CPAP |
Obesity Sleep Apnea Syndromes Apnea Sleep Apnea, Obstructive Respiration Disorders Diabetes Mellitus Prediabetic State |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Nervous System Diseases |