The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction
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|ClinicalTrials.gov Identifier: NCT00919347|
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : May 28, 2012
|Condition or disease||Intervention/treatment|
|Cardiovascular Autonomic Neuropathy Diabetic Autonomic Neuropathy Autonomic Dysfunction||Other: ANSAR ANX 3.0 Software|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Case Control|
|Official Title:||The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction in Diabetic Patients Undergoing Retinal Surgery|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
- Other: ANSAR ANX 3.0 Software
Three values are calculated by the ANSAR ANX 3.0® software of the spectral analysis of HRV and respiration:
- RFa an indicator of parasympathetic function with normal values between 0.5 and 10 bpm2;
- LFa an indicator of sympathetic function also with normal values between 0.5 and 10 bpm2;
- SB or the ratio of LFa/RFa with normal reference values of 0.4 to 3.0.
The ANSAR ANX 3.0® software defines three different levels of autonomic neuropathy (autonomic dysfunction) as follows (see Figure 1):
- Cardiovascular Autonomic Neuropathy (CAN): resting parasympathetic insufficiency (not enough parasympathetic protection for the heart) or RFa < 0.1 bpm2.
- Diabetic Autonomic Neuropathy (DAN), or advanced autonomic dysfunction in non-diabetics, is defined as low autonomics: LFa < 0.5 bpm2 or 0.1 < RFa < 0.5 bpm2.
- Autonomic Dysfunction: normal resting LFa and RFa, but low LFa response to Valsalva or low RFa response to deep breathing.
- The primary outcome will be to quantify, using the ANSR ANX 3.0 technology, the prevalence of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN),referred to as advanced autonomic nervous system dysfunction in non-diabetic patients. [ Time Frame: 15 minutes ]
- The strength of various comorbidities as predictors of autonomic dysfunction in both diabetics and non-diabetics will be evaluated. The differential effect of these various comorbidities in Type I versus Type II diabetes on ANS dysfunction and neuropathy [ Time Frame: 15 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919347
|United States, Alabama|
|Callahan Eye Foundation Hospital|
|Birmingham, Alabama, United States, 35233|