Autonomic Nervous System Modulation Clinical Trial
Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic nervous system state index (ANSSi).
It has been supposed that indexes derived from pulse plethysmographic analysis -the
autonomic nervous system state (ANSS) and ANSS index (ANSSi)- may be useful tools to measure
the autonomic nervous system (ANS) activity but, to date, physiologic experimental evidences
are lacking.
Traditionally,it is widely accepted that ANS modulation and the baro-reflex control can be
non-invasively studied through heart rate variability (HRV) and systolic variability
analyses.
The aim of this study is to assess if PPGA-derived indexes are able to detect changes of ANS
system modulation directed to heart and vessels.
Changes in position of patients lead to changes in the balance of the ANS. One of the most
used manoeuver to stimulate ANS is head-up tilt (HUT). Tilt causes pooling of blood toward
lower body and reduces the venous return to the heart. These activation of ANS leads to an
increase of heart rate and peripheral vascular resistance aiming to maintain arterial
pressure near to the level preceding the challenge (baro-reflex control).
Methods: we study the effects of sympathetic stimulation on ANSS and ANSSi induced with two
different tilt at 45 and 90 degrees angles. We compare the ANSS and ANSSi with HRV analysis
and baro-reflex control analysis. We plan to study 7 volunteers to detect a difference of 30
(standard deviation of 15) between the mean of ANSS and ANSSi at baseline and during tilt,
with a power of 80% and alfa error of 5%.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
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Not yet recruiting |
NCT05922059 -
Effects of Autonomic Nervous System Modulation on Heart Rate Variability and Musculoskeletal Manifestations in Patients With Chronic Neck Pain
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N/A |