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Kintsugi Voice Device Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06374056
Recruitment Status : Recruiting
First Posted : April 18, 2024
Last Update Posted : April 19, 2024
Sponsor:
Collaborators:
Sonar Strategies
Vituity Psychiatry
Information provided by (Responsible Party):
Kintsugi Mindful Wellness, Inc.

Tracking Information
First Submitted Date April 9, 2024
First Posted Date April 18, 2024
Last Update Posted Date April 19, 2024
Actual Study Start Date March 22, 2024
Estimated Primary Completion Date March 22, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2024)		 Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 [ Time Frame: Day 1 ]
Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using sensitivity and specificity.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2024)
  • PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5 [ Time Frame: Day 1 ]
    Determine the performance of the KV Device in discriminating the presence of a current significant depressive episode using the SCID-5-CT diagnosis of current MDD and/or MDE using positive predictive value, negative predictive value, area under the curve, and F-score.
  • Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT [ Time Frame: Day 1 ]
    Determine the performance of the KV Device in discriminating the severity of a current significant depressive episode using the SCID-5-CT severity assessment for those with a diagnosis of current MDD and/or MDE
  • Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9 [ Time Frame: Day 1 ]
    Determine the performance of the Device in discriminating the presence of a current significant depressive symptoms compared to the PHQ-9
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Kintsugi Voice Device Pilot Study
Official Title Kintsugi Voice Device SCID-5-CT Pilot Study
Brief Summary A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks.
Detailed Description

Depression affects approximately 30% of people every year in the United States. Detecting mental health conditions early can help patients get the help they need sooner. Machine Learning Devices may be one way to help clinicians identify patients with mental health conditions. Clinicians may then be able to help patients receive the right level of care earlier. Many researchers are working to increase mental health screening. Machine Learning can detect subtle patterns like changes in the voice when someone is experiencing mental health conditions. Changes in the voice associated with a mental health condition are voice biomarkers.

The purpose of this study is to find correlations between voice and how people sound with clinical diagnoses. Kintsugi Mindful Wellness, Inc. has developed a tool, the Kintsugi Voice Device, that assesses mental health and conditions like depression by studying the voice. The study's goal is to test the ability of the Device to identify depressive symptoms.

Up to 500 people will take part in this research. Subject recruitment is expected to take up to 1 year. Completion of the study activities may take about 2 hours but subjects may stay enrolled for up to 2 weeks based on clinician availability for scheduling the Structured Clinical Interview for DSM-5 (SCID) interview.

Study participants will:

  • Answer brief self-reported eligibility confirmation questionnaires. These answers help the researchers understand participant health history.
  • Schedule a teleconference with a licensed Clinical Psychologist to evaluate their mental health over Zoom. The Clinical Psychologist will guide participants through the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT). The Clinical Psychologist will be licensed in the participant's state of residence. This assessment will be video and audio recorded for quality assurance purposes. If participants do not agree to being videotaped and/or audio recorded, they will be unable to join the study. The SCID-5-CT assessment is for research purposes only and is not intended for treatment purposes. The results of the SCID will not be shared with participants.

On the day of the teleconference with a licensed Clinical Psychologist participants will:

  • Complete three brief self-assessment surveys asking about their electronic device, mental health and quality of life: the Patient Health Questionnaire-9 (PHQ-), Generalized Anxiety Disorder-7 (GAD-7), and the World Health Organization Quality of Life (WHOQOL). These assessments will take approximately 15 minutes in total.
  • Participants will provide an audio recording in response to 3 prompts of their choosing. The audio recording will be inputted to the Kintsugi Voice Device to receive a prediction of current signs of depression. The Kintsugi Voice Device Prediction is for research purposes only and will not be shared with participants.
  • Complete the SCID-5-CT while being videotaped and audio recorded with a licensed psychologist or psychiatrist and participant responses will be recorded. The SCID will allow the clinician to assess participants' current mental status.

This study is intended for research purposes and is not intended for treatment and/or diagnostic purposes. The risks to this study are minimal and/or temporary and short lived. The study team has implemented procedures to minimize them wherever possible. There is always the potential for breach of confidentiality. To minimize this risk, all entries are encrypted. Researchers de-identify personal information using IDs. Researchers will store all data in a secure, password protected database and Google Cloud Platform bucket. Participation may bring up emotional content which could temporarily impact mood. To minimize this risk, everyone will be emailed a list of mental health resources.

There is no cost to subjects for participation. There may be no direct benefit from participation. Indirect benefits may include reduction in stress, learning more about mental health. Knowledge gained from the study could potentially benefit patients in the future.

Only personal and health information directly related to the research is collected, for safety purposes, or as required to provide participants with payment, including:

  • Name
  • Age
  • Address
  • Phone Number
  • Email Address
  • Demographic information (e.g. race, gender, and ethnicity)
  • English Proficiency
  • Emergency Contact Information
  • Audio recording of the SCID-5-CT
  • Video recording of the SCID-5CT
  • Audio recordings in response to prompts
  • Brief Medical History and Medications
  • Results of the SCID-5-CT
  • Device Information
  • PHQ-9 Responses
  • GAD-7 Responses
  • Behavioral and Quality of Life Survey Responses

Identifiable data will be kept for 7 years. De-identified data will be kept indefinitely.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
A
Sampling Method Non-Probability Sample
Study Population This study will enroll up to 500 English speaking subjects >22 years old. Only subjects who meet all eligibility criteria and sign the informed consent will be enrolled. Participants who do not meet the criteria required for participation will not be presented with the opportunity to participate. Screen failures will not be considered a part of this research study.
Condition
  • Depression
  • Depression Moderate
  • Depression Severe
  • Depression Mild
Intervention Device: Kintsugi Voice Device

The Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of depression.

The Kintsugi Voice Device is comprised of a software API and machine learning model that utilizes recorded voice samples as inputs and outputs the detection of signals consistent with current moderate to severe depressive episode as outputs.
Study Groups/Cohorts Depressed
All study participants will undergo the same study procedures. All individuals will complete brief online assessments about their emotional and physical wellbeing, provide audio recorded voice responses to prompts, and complete the SCID-5-CT with a clinician licensed in their state of residence while being audio and video recorded for quality assurance purposes.
Intervention: Device: Kintsugi Voice Device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 15, 2024)		 500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 22, 2025
Estimated Primary Completion Date March 22, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age >22 at the time of informed consent
  • Access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the Internet
  • Stated willingness to be video and audio recorded as part of the study
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Fluency in English
  • Availability for the duration of the study
  • Resides in the United States at the time of consent and during completion of study
  • Contributes to the approximately 50/50 depressed/healthy study population distribution

Exclusion Criteria:

  • Any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., visual impairment, motor impairment, and/or hearing impairment)
  • Any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (E.g., Central Nervous System disorders, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and/or Parkinson's Disease)
  • Any lifetime history of Stroke, cognitive defect (E.g., dementia or Alzheimer's disease), and/or Traumatic Brain Injury
  • Presence of voice disorders that impacts their ability to speak (E.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia)
  • Past or active heavy smokers (an average of >20 cigarettes per day)
  • Subjects who have previously participated in any Kintsugi-sponsored study.
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alexa A Mazur, BA 6107241431 alexa@kintsugihealth.com
Contact: Victoria Graham, MS victoria@kintsugihealth.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT06374056
Other Study ID Numbers 0458
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The study team does not current intend to publish the data associated with the study. Should the study team publish study data, the study data may be made available to other researchers.
Current Responsible Party Kintsugi Mindful Wellness, Inc.
Original Responsible Party Same as current
Current Study Sponsor Kintsugi Mindful Wellness, Inc.
Original Study Sponsor Same as current
Collaborators
  • Sonar Strategies
  • Vituity Psychiatry
Investigators Not Provided
PRS Account Kintsugi Mindful Wellness, Inc.
Verification Date April 2024