Analysis of Sleep Study Data to Assess Depressive Burden
NCT ID: NCT04232267
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
329 participants
OBSERVATIONAL
2020-01-13
2022-03-01
Brief Summary
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Detailed Description
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This is a two (2)-phase, non-significant risk, cross-sectional, naturalistic, single-arm, multi-center study conducted under a common protocol and designed to:
Phase 1: MEB-001 algorithm development (software medical device). Phase 2: Evaluate the effectiveness of the MEB-001 device in assessing physiological parameters that provide clinically significant depressive burden screener.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients prescribed Polysomnology (PSG - sleep study)
Patients that are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbance.
MEB-001
Software medical device used to aid in the screening of patients with potential depressive burden symptoms.
Interventions
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MEB-001
Software medical device used to aid in the screening of patients with potential depressive burden symptoms.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
18 Years
75 Years
ALL
No
Sponsors
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Medibio Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Melissa Bruner
Role: STUDY_DIRECTOR
Medibio Limited
Archie Defillo, MD
Role: STUDY_CHAIR
Medibio Limited
Archie Defillo, MD
Role: PRINCIPAL_INVESTIGATOR
Medibio Limited
Locations
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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
Countries
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Other Identifiers
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CIP-0018
Identifier Type: -
Identifier Source: org_study_id