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Completed

NCT Number: NCT03133013

Objective Evaluation of Depression Using Sleep EEG

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.

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Key information

Age range

30 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Sleep Medicine Center

Redwood City, California, 94063, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SLEEPSCOPE

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Study on Realization of Objective Evaluation Method of Depression Using Sleep EEG

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2017
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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