Clinical trial NCT05708222: Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
Official title: Investigation of the Likelihood of a Current Major Depressive Episode in Individuals Referred to Sleep Clinics for Polysomnography (PSG) Assessment Using the MEB-001 Device.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Episode
Depression
Depressive Disorder
Depressive Disorder, Major
Depression Mild
Keywords: Major Depressive Episodes
Depression
Sleep Study
Lead sponsor: Medibio Limited
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 715
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are at least 22 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 evaluated for participation in this study.

Brief summary: The objective of this study is to collect data to finalize the development of MEB-001 software as a medical device. The data collected in this study will be used to develop MEB-001 machine learning algorithms by training the algorithms to match the patient's demographic and clinical information, and the objective physiological signals (i.e., electroencephalogram (EEG) and electrocardiogram (ECG)) recorded during PSG with the diagnosis of cMDE performed through the MINI neuropsychiatric evaluation.

Detailed description: This is a two (2)-phase, single-arm, prospective, non-significant risk, multi-center trial where each enrolled subject's data will be used for the development of MEB-001.

Study Population:

Subjects who are at least 22 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 evaluated for participation in this study.

The selection of the population involved in the study will consider the geographic diversity needed to obtain a representative sample of the intended use population. Centers will be selected to secure geographic and clinical diversity across the USA to obtain a representative distribution of the intended patient population.

All patients undergoing PSG due to primary or secondary sleep disorders, which include, but are not limited to, Sleep-Related Movement Disorders, Sleep-Related Breathing Disorders, Intrinsic and Extrinsic Circadian Rhythm Sleep-Wake Disorders, Hypersomnia, Parasomnia, and Insomnia, will be consecutively recruited, according to the inclusion/exclusion criteria.

Eligibility criteria: Inclusion Criteria:

Subjects must meet ALL the following conditions to be eligible to participate in the study:

1. Subject is age ≥ 22 years and ≤ 75 years.
2. Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
3. Subject is willing and able to provide informed consent.
4. Subject has the ability to read and understand the instructions for the study.
5. Subject is willing to adhere to study procedures.
6. Subject is willing to undergo full night diagnostic PSG study, as prescribed.

Exclusion Criteria:

Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:

1. Subject has a pacemaker.
2. Subject has undergone a heart transplant.
3. Subject is undergoing a full night C-PAP titration study.

Primary outcomes:
measure: Development of software as a medical device for the assessment of current major depressive episodes.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Medbridge Healthcare
state: Florida
city: Blaine
country: United States
facility: Lakeland Sleep Store
state: Minnesota
city: Plymouth
country: United States
facility: Lakeland Sleep
state: Minnesota
city: Clayton
country: United States
facility: Medbridge Healthcare
state: North Carolina
city: Raleigh
country: United States
facility: Medbridge Healthcare
state: North Carolina
city: Wilson
country: United States
facility: Medbridge Healthcare
state: North Carolina
city: Columbus
country: United States
facility: Ohio Sleep Solutions
state: Ohio
city: Grove City
country: United States
facility: Ohio Sleep Solutions
state: Ohio
city: North Charleston
country: United States
facility: Medbridge Healthcare
state: South Carolina
city: Sumter
country: United States
facility: Medbridge Healthcare
state: South Carolina
city: Austin
country: United States
facility: Comprehensive Sleep Medicine Associates
state: Texas
city: Sugar Land
country: United States
facility: Comprehensive Sleep Medicine Associates
state: Texas
city: The Woodlands
country: United States
facility: Comprehensive Sleep Medicine Associates
state: Texas
Study officials:
affiliation: Medibio Limited
name: Archie Defillo, MD
role: STUDY_CHAIR
affiliation: Medibio Limited
name: Melissa E Bruner, MS
role: STUDY_DIRECTOR
References:
citation: Caldirola D, Dacco S, Cuniberti F, Grassi M, Alciati A, Torti T, Perna G. First-onset major depression during the COVID-19 pandemic: A predictive machine learning model. J Affect Disord. 2022 Aug 1;310:75-86. doi: 10.1016/j.jad.2022.04.145. Epub 2022 Apr 27.
citation: Caldirola D, Cuniberti F, Dacco S, Grassi M, Torti T, Perna G. Predicting New-Onset Psychiatric Disorders Throughout the COVID-19 Pandemic: A Machine Learning Approach. J Neuropsychiatry Clin Neurosci. 2022 Summer;34(3):233-246. doi: 10.1176/appi.neuropsych.21060148. Epub 2022 Mar 21.
citation: Perna G, Dacco S, Alciati A, Cuniberti F, De Berardis D, Caldirola D. Childhood maltreatment history for guiding personalized antidepressant choice in major depressive disorder: Preliminary results from a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110208. doi: 10.1016/j.pnpbp.2020.110208. Epub 2020 Dec 15.
citation: Dacco S, Caldirola D, Grassi M, Alciati A, Perna G, Defillo A. High prevalence of major depression in US sleep clinics: the need for routine depression screening in sleep services. J Clin Sleep Med. 2023 Apr 1;19(4):835-836. doi: 10.5664/jcsm.10398.
citation: Perna G, Alciati A, Dacco S, Grassi M, Caldirola D. Personalized Psychiatry and Depression: The Role of Sociodemographic and Clinical Variables. Psychiatry Investig. 2020 Mar;17(3):193-206. doi: 10.30773/pi.2019.0289. Epub 2020 Mar 12.
citation: Perna G, Cuniberti F, Dacco S, Nobile M, Caldirola D. Impact of respiratory protective devices on respiration: Implications for panic vulnerability during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:772-778. doi: 10.1016/j.jad.2020.09.015. Epub 2020 Sep 7.