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Objective Evaluation of Depression Using Sleep EEG

This study is not yet open for participant recruitment.
Verified May 2017 by Clete A. Kushida, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03133013
First Posted: April 28, 2017
Last Update Posted: May 16, 2017
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.
Information provided by (Responsible Party):
Clete A. Kushida, Stanford University
  Purpose
The purpose of this study is to test the ability of a brainwave measurement device (SLEEPSCOPE) in identifying and assisting in the diagnosis of depression. The brainwave data from individuals with untreated depression and healthy participants will be collected and analyzed. The ability to obtain brainwave data from individuals in their homes while they're sleeping would represent a significant advance in depression research.

Condition Intervention
Depression Device: SLEEPSCOPE

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study on Realization of Objective Evaluation Method of Depression Using Sleep EEG

Further study details as provided by Clete A. Kushida, Stanford University:

Primary Outcome Measures:
  • Assist in the diagnosis of depression [ Time Frame: 1 month ]
    The SLEEPSCOPE data will be analyzed to determine if it can help to identify individuals with depression


Estimated Enrollment: 64
Anticipated Study Start Date: August 1, 2017
Estimated Study Completion Date: April 30, 2019
Estimated Primary Completion Date: April 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individuals with Untreated Depression
32 participants diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and defined as a score of 15 or higher on the clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device.
Device: SLEEPSCOPE
Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
Healthy Participants
32 healthy participants with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and Diagnostic and Statistical Manual (DSM-5) criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9). The participants will be attached to the SLEEPSCOPE device.
Device: SLEEPSCOPE
Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear

Detailed Description:

The purpose of study is to collect and analyze human sleeping brainwave data, to better understand depression in humans.

First visit:

  • Informed consent procedures, including explanation of research background, purpose, details of implementation, and study benefits and risks
  • Interview with questionnaires (MINI International Psychiatric Interview, Hamilton Rating Scale for Depression, Beck Depression Inventory, Patient Health Questionnaire for Depression [PHQ-9]), physical examination.
  • Urine drug sample for screening of controlled substances.
  • Inform participants that those qualifying will be informed whether or not to proceed with second visit

Second visit:

  • Explanation of EEG measurement (placement of two electrodes, one on the forehead and one behind the ear)
  • Sleep diary provided for participant to complete at home for each night until third visit
  • Distribution of EEG devices for home use
  • EEG measurement conducted at participant's residence for three nights of stable sleep-wake cycles

Third visit:

- Collect EEG devices and check completeness of downloaded data

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Individuals with Untreated Depression:

- 16 men and 16 women aged from 30 to 59 years, with an approximate ethnic balance of 10 Asian, 3 White and 3 other ethnicity for each gender, whom are diagnosed with Major Depressive Disorder by a psychiatric specialist of this research according to MINI screening and DSM-5 criteria, and defined as a score of 15 or higher on the clinician-administered Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9).

Healthy Participants:

- 16 men and 16 women age-, ethnic-, and gender-matched healthy participants to the cohort with untreated depression, with absence of mental disorders, including but not limited to depression and sleep disorders, by a psychiatric specialist according to MINI screening and DSM-5 criteria, and negative Hamilton Rating Scale for Depression, Beck Depression Inventory, and Patient Health Questionnaire for Depression (PHQ-9).

Exclusion Criteria:

Participants corresponding to any of the following conditions are considered ineligible for the trial.

  • Diagnosed with epilepsy or other organic brain disorder.
  • Medical conditions resulting in depressive symptoms such as hypothyroidism, Cushing's disease, systemic lupus erythematosus; neurological conditions resulting in depressive symptoms such as Parkinson's disease, Huntington's disease, multiple sclerosis
  • Patients with suspected sleep apnea, based on symptoms and a BMI of 30 or greater
  • Prescribed interferon regularly with stimulants, opioid drugs (Ritalin, Opioid, etc.) and steroids
  • Repetitive thoughts of death, current thoughts about suicide, suicide attempts, or a suicide plan
  • Tested positive to controlled substance use by a urine drug screening before commencement of testing
  • Current or past drug or alcohol dependence
  • Shift work or rotating work schedule
  • Nursing, pregnant or planning to become pregnant
  • Participating in other clinical trials
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133013


Contacts
Contact: Clete A Kushida, M.D., Ph.D. 650-721-7560 clete@stanford.edu
Contact: Kary Newman 650-721-7574 knewman2@stanford.edu

Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Clete A Kushida, M.D., Ph.D. Stanford University
  More Information

Responsible Party: Clete A. Kushida, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03133013     History of Changes
Other Study ID Numbers: 41103
First Submitted: April 25, 2017
First Posted: April 28, 2017
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders


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