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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03133013
Study type Interventional
Source Stanford University
Contact
Status Completed
Phase N/A
Start date May 1, 2017
Completion date May 31, 2019

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