- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238285
Production of Nonverbal Acoustic Signals and Resulting Physiological Responses (SINOVE-PRO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Like many other animals, humans produce nonverbal vocal signals including screams, grunts, roars, cries and laughter across a variety of contexts. Many of these signals (such as cries) are already produced at birth and likely serve a number of important biological and social functions. In addition, human speech is characterised by nonlinguistic acoustic parameters (such as pitch, formant frequencies, and nonlinear phenomena) that are known to correlate with biologically important traits of the vocalizer.
However, despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal signals remain little studied and poorly understood in humans.
Theses studies aim to improve the understanding of the nature and function of non-verbal signals. Thus, this study is part of a long-term research project in which investigators are trying to clarify the information contained in the acoustic structure of human non-verbal signals, and to investigate the factors influencing their production.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ROLAND PEYRON, MDPhD
- Phone Number: +33 (0)477127805
- Email: roland.peyron@chu-st-etienne.fr
Study Contact Backup
- Name: Nicolas MATHEVON, PhD
- Phone Number: +33 04 77 48 50 22
- Email: nicolas.mathevon@univ-st-etienne.fr
Study Locations
-
-
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Saint-Etienne, France, 42055
- Recruiting
- Centre Hospitalier Universitaire de Saint-Étienne
-
Principal Investigator:
- Roland PEYRON, MD PHD
-
Sub-Investigator:
- David REBY, MDPHD
-
Sub-Investigator:
- Nicolas MATHEVON, MDPHD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participant should be affiliated or entitled to a social security scheme
Exclusion Criteria:
- Pregnant women
- Voice production disorders
- Hearing impairment, speech production disorders or major health problems.
- Chronic smoker (more than 10 cigarettes per day)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy adult population aged 18 to 80 years
Participants will be asked to produce vocal sounds of different nature according to the non-verbal parameters of interest for the given study.
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Participants will be asked to produce vocal sounds of different nature according to the non-verbal parameters of interest for the given study. For example, they can read a script containing vowels ('a', 'e', 'i', 'o', 'u'), short sentences ('hello, how are you'), longer passages of standardised reading texts, and can also be asked to speak freely about any topic ('freedom of speech'). They can be asked to play a role or to imitate a particular emotional state. For example, "imagine that you have just been told that you have won a million euros in the lottery. Produce a vocalisation to express your excitement" or "talk to your dog your dog by imagining that he has done a negative action and then do the same thing by imagining that this time imagining that the action was positive". |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vocal analysis
Time Frame: During the vocal production
|
Participants will receive instructions on what to say or what type of non-verbal vocalisation to produce during the manipulation. The vocalisations thus produced by the participants will be systematically recorded and analysed using software adapted to acoustic analysis Measurement of acoustic variables such as fundamental frequency (pitch), vocal tract resonances (formants) and vocal disturbances (jitter, shimmer), the nonlinearities and chaotic/noise properties of vocalisations |
During the vocal production
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate (bpm)
Time Frame: During the vocal production
|
During the vocal production
|
|
|
Skin conductance (Siemens)
Time Frame: During the vocal production
|
During the vocal production
|
|
|
Skin temperature (°C)
Time Frame: During the vocal production
|
During the vocal production
|
|
|
Nociception Level Index (NOL)
Time Frame: During the vocal production
|
A non-invasive finger probe, containing four sensors, will be placed on the on the index finger of the participants.
|
During the vocal production
|
|
Pupillary diameter (millimeter)
Time Frame: During the vocal production
|
Using a high resolution binocular for automated pupil diameter measurement with an infrared camera
|
During the vocal production
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: ROLAND PEYRON, MDPHD, Centre Hospitalier Universitaire de Saint Etienne
- Study Director: Nicolas MATHEVON, PhD, University of Saint-Etienne, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20CH259
- 2020-A03457-32: (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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