Back to resultsA Study of Spoken Language in Mania
Primary Purpose
Manic Episode, Bipolar I Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Research interview
Sponsored by
About this trial
This is an interventional supportive care trial for Manic Episode
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recording Session During Hospitalization
Arm Description
While inpatient, participants will undergo a research interview with recorded audio.
Outcomes
Primary Outcome Measures
Acoustic Differences
The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time.
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.
Semantic Differences
Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05956340
Brief Title
A Study of Spoken Language in Mania
Official Title
Computational Analysis of Spoken Language in Mania
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to find if there are changes with voice and speech during episodes of mania.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manic Episode, Bipolar I Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recording Session During Hospitalization
Arm Type
Experimental
Arm Description
While inpatient, participants will undergo a research interview with recorded audio.
Intervention Type
Behavioral
Intervention Name(s)
Research interview
Intervention Description
Research interview to capture speech data with high quality cardioid headset microphone
Primary Outcome Measure Information:
Title
Acoustic Differences
Description
The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time.
Time Frame
Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Title
Syntactical Differences
Description
Audio data will be transcribed using voice to text software and then analyzed for syntactical elements of speech including sentence structure and grammar.
Time Frame
Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Title
Semantic Differences
Description
Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level.
Time Frame
Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremiah Joyce, MD, MS
Phone
507-284-0557
Email
Joyce.Jeremiah@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Frye, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremiah Joyce, MD
Email
Joyce.Jeremiah@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of Spoken Language in Mania
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