A Study of Spoken Language in Mania

NCT05956340 | Completed

• 1 other identifier: 22-010487
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Manic Episode; Bipolar I Disorder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Recording Session During Hospitalization

EXPERIMENTAL

While inpatient, participants will undergo a research interview with recorded audio.

Behavioral: Research interview

Interventions

Research interview BEHAVIORAL

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

Recording Session During Hospitalization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mania

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Frye, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 21, 2023
• Study Start: April 27, 2023
• Primary Completion: September 6, 2024
• Study Completion: September 9, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)