NCT04846413

Brief Summary

In this observational pilot study, the investigators will record and assess voice samples from healthy participants and those participants affected by neurologic diseases to evaluate possible differences in voice features.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

April 12, 2021

Last Update Submit

March 21, 2023

Conditions

Voice DisordersNeurologic Disorder

Keywords

voice analysismachine learningneurologic disorders

Outcome Measures

Primary Outcomes (1)

  • Voice analysis

    Voice features obtained by using Support Vector Machine algorithm

    Voice analysis with machine learning algorithms will be implemented immediately after voice recording, during the clinical evaluation of each participant.

Study Arms (1)

Patients

Patients affected by neurologic disorders showing a prominent voice impairment.

Other: Speech task

Interventions

Speech taskOTHER

Speech task which consists of a sustained emission of the vowel /e/.

Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit neurologic patients not taking any oral medications or alcohol and any drugs acting on the central nervous system at the time of the study.

You may qualify if:

  • Clinical diagnosis of neurologic disorders

You may not qualify if:

  • smoking
  • bilateral/unilateral hearing loss
  • respiratory disorders
  • conditions affecting the vocal cords, including nodules.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antonio Suppa

Pozzilli, 86077, Italy

RECRUITING

MeSH Terms

Conditions

Voice DisordersNervous System Diseases

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Suppa, MD, PhD

CONTACT

3494940365antonio.suppa@uniroma1.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

September 1, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

IT(1)