Clinical trial NCT04232267: Analysis of Sleep Study Data to Assess Depressive Burden
Official title: Development and Validation of an Algorithm to Identify a Clinically Significant Depressive Burden in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment (Sleep Analysis of Depressive Burden - SADB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Depressive; Behavioral Disorder
Mood Disorders
Lead sponsor: Medibio Limited
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are at least 18 years old but not older than 75 years old, who have been referred to a sleep clinic for sleep disturbances and sign an informed consent form (ICF) will be eligible to participate in this study.

Brief summary: 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).

Detailed description: 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 BDI-II.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Report assists in the detection of clinically significant depressive burden.
timeFrame: The study consists of 1 study visit (baseline).
measure: Evaluate algorithm accuracy, sensitivity and specificity.
timeFrame: The study consists of 1 study visit (baseline).
Secondary outcomes:
measure: Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.
timeFrame: The study consists of 1 study visit (baseline).
measure: System reliability and internal consistency.
timeFrame: The study consists of 1 study visit (baseline).
Other outcomes:
Locations:
city: Blaine
country: United States
facility: Restore Sleep Clinic
state: Minnesota
city: Plymouth
country: United States
facility: Lakeland Sleep and CPAP
state: Minnesota
city: Columbus
country: United States
facility: Ohio Sleep Solutions
state: Ohio
city: Grove City
country: United States
facility: Ohio Sleep Solutions
state: Ohio
city: Hilliard
country: United States
facility: Ohio Sleep Solutions
state: Ohio
Study officials:
affiliation: Medibio Limited
name: Melissa Bruner
role: STUDY_DIRECTOR
affiliation: Medibio Limited
name: Archie Defillo, MD
role: STUDY_CHAIR
affiliation: Medibio Limited
name: Archie Defillo, MD
role: PRINCIPAL_INVESTIGATOR
References: