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A Study of Spoken Language in Mania

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05956340
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
16
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Research interview
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Computational Analysis of Spoken Language in Mania
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recording Session During Hospitalization

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

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

Outcome Measures

Primary Outcome Measures

  1. Acoustic Differences [Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment]

    The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time.

  2. Syntactical Differences [Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment]

    Audio data will be transcribed using voice to text software and then analyzed for syntactical elements of speech including sentence structure and grammar.

  3. Semantic Differences [Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment]

    Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Mark Frye, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Mark Frye, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05956340
Other Study ID Numbers:
  • 22-010487
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Mania

Study Results

No Results Posted as of Jul 21, 2023