An interventional study of Tilt test in Autonomic Nervous System Modulation, sponsored by ASST Fatebenefratelli Sacco. Completed at 1 site in Italy. Open to participants aged 25 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-15.
Sponsored by ASST Fatebenefratelli Sacco · Not applicable, Interventional, and Basic science
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%.
ASST Fatebenefratelli Sacco is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
tilt
Other: Tilt test
The experiment protocol consists of a sequence of passive postural changes gained with a tilt table, each of them lasting 10 minutes. The sequence consists of: (i) baseline recording in supine position; (ii) tilt at 45 degrees angle; (iii) recovery period in supine position; (iv) tilt at 90 degrees angle and (v) recovery in supine position.
to measure the degree of correlation of ANSS and ANSSi with LF/HF and baroreflex sensitivity and their agreement in response to an orthostatic sympathetic load
Time frame: 1 week
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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ASST Fatebenefratelli Sacco