Analysis of Sleep Study Data to Assess Depressive Burden

Completed

Conditions studied: Sleep Disorder, Depressive; Behavioral Disorder, Mood Disorders

In brief

This study evaluates the effectiveness of the MEB-001 device in assessing physiological parameters that provide a clinically significant depressive burden screener. This study uses objective physiological markers from MEB-001 to estimate the clinically significant depressive burden as subjectively reported by the subject with the Beck Depression Inventory - II (BDI-II).

Key facts

Study ID

NCT04232267

Run by

Medibio Limited

People needed

329

Starts

2020-01-13

Expected to finish

2022-03-01

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is age ≥18 years and ≤75 years.
• Subject is willing and able to provide consent.
• Subject has the ability to read and understand the instructions for the study.
• Subject is willing to adhere to study procedures.
• Subject is willing to undergo full night PSG study, as prescribed.

You may not qualify if…

• Subject has a pacemaker.
• Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).

Where it is running

• Restore Sleep Clinic — Blaine, Minnesota, United States
• Lakeland Sleep and CPAP — Plymouth, Minnesota, United States
• Ohio Sleep Solutions — Columbus, Ohio, United States
• Ohio Sleep Solutions — Grove City, Ohio, United States
• Ohio Sleep Solutions — Hilliard, Ohio, United States

Full record on ClinicalTrials.gov

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