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The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

NCT00919347 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2012-05-28

No results posted yet for this study

Summary

The purpose of this study is to measure the prevalence and severity of cardiac autonomic neuropathy (CAN), diabetic autonomic neuropathy (DAN) which in non-diabetics is termed advanced nervous system (ANS) dysfunction, and autonomic dysfunction as well as the overall sympathovagal balance (SB) in the CEFH population of diabetic patients versus non-diabetic patients undergoing elective vitreoretinal surgery.

Conditions

  • Cardiovascular Autonomic Neuropathy
  • Diabetic Autonomic Neuropathy
  • Autonomic Dysfunction

Interventions

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: 1. RFa an indicator of parasympathetic function with normal values between 0.5 and 10 bpm2; 2. LFa an indicator of sympathetic function also with normal values between 0.5 and 10 bpm2; 3. 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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00919347 on ClinicalTrials.gov