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Autonomic Nervous System ModulationNCT01966198

Estimation of Autonomic Nervous System Modulation by Pulse Plethysmographic Analysis

A study testing Tilt test in people with Autonomic Nervous System Modulation, run by ASST Fatebenefratelli Sacco at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Autonomic Nervous System Modulation
What is being tested?
Tilt test
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteItaly
Study dates
Oct 2013to Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • adult healthy humans (american society of anesthesiologists class I)
  • age between 25 and 35 years old
  • no assumption of any drug, beverages containing caffeine or alcohol during the previous 24 hours
  • fasting 3 hours before the study protocol

Who cannot join

  • american society of anesthesiologists class >1
  • age <25 or >35 years
  • pregnancy
  • accidental discover of non sinus cardiac rhythm or ectopic beats >5%

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Ospedaliera "Luigi Sacco" - Polo Universitario - University of Milan

    Milan, 20157

Other trials in Italy

About this study

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).

Read the detailed description

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%.

Being tested
Tilt test
Keywords
pulse plethysmography, autonomic nervous system, heart rate variability, baro-reflex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tilt testOther

    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.

Study groups in NCT01966198
Study groupRoleWhat they receive
all patientsExperimentaltilt
Receives: Other: Tilt test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01966198
Sponsor's protocol ID
31082013
Status last verified
Apr 2014
First submitted
12 Oct 2013
Last updated
15 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

    PubMed 8598068

  • Bonhomme V, Uutela K, Hans G, Maquoi I, Born JD, Brichant JF, Lamy M, Hans P. Comparison of the surgical Pleth Index with haemodynamic variables to assess nociception-anti-nociception balance during general anaesthesia. Br J Anaesth. 2011 Jan;106(1):101-11. doi: 10.1093/bja/aeq291. Epub 2010 Nov 4.

    PubMed 21051493

  • Hamunen K, Kontinen V, Hakala E, Talke P, Paloheimo M, Kalso E. Effect of pain on autonomic nervous system indices derived from photoplethysmography in healthy volunteers. Br J Anaesth. 2012 May;108(5):838-44. doi: 10.1093/bja/aes001. Epub 2012 Feb 26.

    PubMed 22369767

  • Paloheimo MP, Sahanne S, Uutela KH. Autonomic nervous system state: the effect of general anaesthesia and bilateral tonsillectomy after unilateral infiltration of lidocaine. Br J Anaesth. 2010 May;104(5):587-95. doi: 10.1093/bja/aeq065. Epub 2010 Mar 30.

    PubMed 20354006

  • Montano N, Ruscone TG, Porta A, Lombardi F, Pagani M, Malliani A. Power spectrum analysis of heart rate variability to assess the changes in sympathovagal balance during graded orthostatic tilt. Circulation. 1994 Oct;90(4):1826-31. doi: 10.1161/01.cir.90.4.1826.

    PubMed 7923668

  • Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93. doi: 10.1161/01.res.59.2.178.

    PubMed 2874900

  • Cooke WH, Hoag JB, Crossman AA, Kuusela TA, Tahvanainen KU, Eckberg DL; New Collective Author. Human responses to upright tilt: a window on central autonomic integration. J Physiol. 1999 Jun 1;517 ( Pt 2)(Pt 2):617-28. doi: 10.1111/j.1469-7793.1999.0617t.x.

    PubMed 10332107

  • Kamiya A, Iwase S, Sugiyama Y, Mano T, Sudoh M. Vasomotor sympathetic nerve activity in men during bed rest and on orthostasis after bed rest. Aviat Space Environ Med. 2000 Feb;71(2):142-9.

    PubMed 10685588

  • Colombo R, Marchi A, Borghi B, Fossali T, Rech R, Castelli A, Corona A, Guzzetti S, Raimondi F. Pulse Photoplethysmographic Analysis Estimates the Sympathetic Activity Directed to Heart and Vessels. Anesthesiology. 2015 Aug;123(2):336-45. doi: 10.1097/ALN.0000000000000712.

    PubMed 26035252

Questions about this trial

What is this clinical trial studying?

A study testing Tilt test in people with Autonomic Nervous System Modulation, run by ASST Fatebenefratelli Sacco at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01966198, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.

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