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ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder

This study is currently recruiting participants.
Verified February 2012 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
MediTECH Electronic GmbH
AudioProfiling, Dr. Joerg Langner
Information provided by (Responsible Party):
Michael Colla, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01104623
First received: April 14, 2010
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.


Condition
Attention-Deficit/Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 1 Study of Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ADHD - Patients
Adults (18-50 years old). All eligible subjects will experience the voice recording procedure followed by the assessment of adult ADHD diagnostics. The diagnostic guidelines for ADHD in adulthood will be accomplished as outlined by expert consensus of the German Society for Psychiatry, Psychotherapy and Neurology, with a semi-structured clinical interview following the DSM-IV-TR criteria and the ADHD-Checklist (ADHD-CL) for DSM-IV (Hesslinger et al., 2002) to assess the severity of ADHD-Symptoms. Childhood ADHD symptoms will be rated retrospectively amongst others by using the short version (WURS-k) of the Wender Utah Rating Scale (Ward et al., 1993), German version (Retz-Junginger et al., 2002). To strengthen the validity of the ADHD diagnosis the reported symptoms were corroborated by second party reports.
Healthy Controls
Adults(18-50 years old). All eligible subjects will experience the voice recording procedure followed by the ADHD-Checklist (ADHD-CL) for DSM-IV (Hesslinger et al., 2002. To assess the severity of Non-ADHD, the absence of childhood ADHD symptoms will be rated retrospectively amongst others by using the short version (WURS-k) of the Wender Utah Rating Scale (Ward et al., 1993), German version (Retz-Junginger et al., 2002).

Detailed Description:

This project aims to develop an objective diagnostic instrument for ADHD through an automatic voice-analysis system, which uses as input the natural speech of the participants. The underlying voice-analysis procedure was developed by J. Langner at Humboldt University of Berlin (Langner 2003). It ignores the semantic content of spoken words and extracts prosodic and sound features from the speech.

Aims of the study:

  • deliver optimized multivariate logistic regression models of prosodic and sound properties of speech for ADHD.
  • observe sensitivity and specificity of the voice-analysis procedure.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

German speaking: Adults, age 18-50 years.

Criteria

Inclusion Criteria:

  1. Age 18-50.
  2. Written informed consent.
  3. Adult ADHD / Non-ADHD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
  4. Normal vocal functioning, negative history for voice or laryngeal disorders.
  5. Currently euthyroid condition; in case of past history of thyroid disease and need for current pharmacological treatment, patient needs to be on stable medication for at least 4 weeks.

Exclusion Criteria:

  1. Exclusion of borderline and antisocial personality disorder, assessed by the German version of the SCID-II (Fydrich et al., 1997).
  2. Exclusion of schizophrenia and psychotic disorders not otherwise specified.
  3. Exclusion of Epilepsia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104623

Locations
Germany
Center for ADHD Research, Department of Psychiatry, Charite - University Medicine Recruiting
Berlin, Germany, 14050
Contact: Michael Colla, PhD     ++49-30-8445 ext 8704     michael.colla@charite.de    
Contact: Daina Langner, PhD     ++49-30-8445 ext 8478     daina.langner@charite.de    
Principal Investigator: Michael Colla, PhD            
Principal Investigator: Daina Langner, PhD            
Principal Investigator: Laura Gentschow            
Sponsors and Collaborators
Charite University, Berlin, Germany
MediTECH Electronic GmbH
AudioProfiling, Dr. Joerg Langner
Investigators
Study Chair: Michael Colla, PhD Center for ADHD Research, Department of Psychiatry, Charite - University Medicine Berlin
  More Information

Additional Information:
ADHD - Voice Analysis  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Michael Colla, Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01104623     History of Changes
Other Study ID Numbers: AiF KF2247401-AK9-1
Study First Received: April 14, 2010
Last Updated: February 7, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013