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NCT05956340 Clinical Trial

A Study of Spoken Language in Mania

Bipolar I Disorder Clinical Trial

Official title:
Computational Analysis of Spoken Language in Mania

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05956340
Other study ID # 22-010487
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 19, 2023
Est. completion date August 2024

Study information
Verified date September 2023
Source Mayo Clinic
Contact Jeremiah Joyce, MD, MS
Phone 507-284-0557
Email Joyce.Jeremiah@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research is being done to find if there are changes with voice and speech during episodes of mania.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Provision of informed consent before any study procedures are performed - English speaker - Documented clinical diagnosis for Bipolar I Disorder - Undergoing hospitalization, or boarding in the Emergency Department, for mania as determined by primary clinical staff Exclusion Criteria: - Positive urine drug screen for amphetamines or cocaine. - Expressing paranoid delusions regarding electronic surveillance. - Documented clinical diagnosis of developmental delay. - Currently involuntarily hospitalized. - Deemed at risk for aggression. - Failure to comprehend study objectives via comprehension questionnaire. - Individuals who have a guardian and are unable to consent for themselves. - Current communicable disease requiring isolation.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Research interview
Research interview to capture speech data with high quality cardioid headset microphone

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acoustic Differences The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time. Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Primary Syntactical Differences Audio data will be transcribed using voice to text software and then analyzed for syntactical elements of speech including sentence structure and grammar. Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Primary Semantic Differences Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level. Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
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