The Relative Prevalence and Severity of Autonomic Nervous System Dysfunction

The University of Alabama at Birmingham

Status: Completed

Conditions: Cardiovascular Autonomic Neuropathy; Diabetic Autonomic Neuropathy; Autonomic Dysfunction

Treatments: Other: ANSAR ANX 3.0 Software

Study type: Observational

Funder types: Other

Identifiers

NCT00919347

F080909006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type I and Type II Diabetic patients 19 or older who are scheduled for elective surgery to improve vision impaired by diabetic retinopathy
• Patients scheduled during the same time period without diabetes for retinal surgery will serve as an age and gender matched reference group to undergo the non-invasive ANS testing on the day of surgery

Exclusion criteria

• Inability to stand will only do baseline, deep breathing and Valsalva portions (A-D) of the testing as described in section 8.1
• Patients with syncope on standing will only do portions A-D of the test
• Inability to cooperate with deep breathing and Valsalva
• Tracheoscopy or otherwise not able to perform a Valsalva
• Not desiring to participate after informed consent
• Known history of idiopathic dysautonomia
• Pulmonary difficulties associated with hyperventilation, including acute URI
• Pacemaker dependent
• Persistently high intraocular pressure despite treatment
• Atrial fibrillation
• Ventricular arrhythmias greater than 10 beats per minute
• Taking MAO inhibitors