Objective Evaluation of Depression Using Sleep EEG

NCT03133013 | Completed

• 1 other identifier: 41103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Assist in the diagnosis of depression

  The SLEEPSCOPE data will be analyzed to determine if it can help to identify individuals with depression

  1 month

Study Arms (2)

Individuals with Untreated Depression

EXPERIMENTAL

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

Healthy Participants

OTHER

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

Interventions

SLEEPSCOPE DEVICE

Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear

Healthy Participants; Individuals with Untreated Depression

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Clete A Kushida, M.D., Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: May 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)