Autonomic Function in Obstructive Sleep Apnea
2 other identifiers
interventional
70
1 country
1
Brief Summary
The purpose of this study is to determine if obstructive sleep apnea (OSA) causes autonomic dysfunction independent of its effects on hyperglycemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 24, 2017
February 1, 2017
6 years
May 19, 2008
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood glucose level, composite autonomic system score (CASS), homeostasis assessment model (HOMA), insulin sensitivity index (ISI)
6 months
Study Arms (1)
A
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University
Nashville, Tennessee, 37232, United States
Related Publications (1)
Peltier AC, Bagai K, Artibee K, Diedrich A, Garland E, Elasy T, Shi Y, Wang L, Feldman EL, Robertson D, Malow BA. Effect of mild hyperglycemia on autonomic function in obstructive sleep apnea. Clin Auton Res. 2012 Feb;22(1):1-8. doi: 10.1007/s10286-011-0131-9. Epub 2011 Jul 28.
PMID: 21796355RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda C. Peltier, MD, MS
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
March 1, 2006
Primary Completion
March 1, 2012
Study Completion
December 1, 2012
Last Updated
February 24, 2017
Record last verified: 2017-02