Autonomic Function in Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amanda Peltier, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00681161
First received: May 19, 2008
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea
Other: continuous positive airway pressure (CPAP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Autonomic Function in Obstructive Sleep Apnea (OSA)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • blood glucose level, composite autonomic system score (CASS), homeostasis assessment model (HOMA), insulin sensitivity index (ISI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2006
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681161

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Amanda C. Peltier, MD, MS Vanderbilt University
  More Information

Publications:
Responsible Party: Amanda Peltier, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00681161     History of Changes
Other Study ID Numbers: K23NS056009, 1K23 NS056009-01A1
Study First Received: May 19, 2008
Last Updated: July 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
obstructive sleep apnea
OSA
diabetes
pre-diabetic condition
obesity
blood glucose
continuous positive airway pressure
CPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 19, 2014