Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)

Depression Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708222
• Other study ID #: CIP-0089
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Medibio Limited
• Contact: Melissa E Bruner, MS
• Phone: +1(612) 616-5005
• Email: melissa.bruner[@]medibio.com.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Episode

Intervention

Device:
• MEB-001
The study is for the development of a software medical device. The study participant will complete study specific questionnaires and undergo a routine sleep study. The medical device will not provide any treatment or interventions.

Locations

Country	Name	City	State
United States	Comprehensive Sleep Medicine Associates	Austin	Texas
United States	Lakeland Sleep Store	Blaine	Minnesota
United States	Medbridge Healthcare	Bradenton	Florida
United States	Medbridge Healthcare	Clayton	North Carolina
United States	Ohio Sleep Solutions	Columbus	Ohio
United States	Ohio Sleep Solutions	Grove City	Ohio
United States	Medbridge Healthcare	North Charleston	South Carolina
United States	Lakeland Sleep	Plymouth	Minnesota
United States	Medbridge Healthcare	Raleigh	North Carolina
United States	Comprehensive Sleep Medicine Associates	Sugar Land	Texas
United States	Medbridge Healthcare	Sumter	South Carolina
United States	Comprehensive Sleep Medicine Associates	The Woodlands	Texas
United States	Medbridge Healthcare	Wilson	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medibio Limited

Country where clinical trial is conducted

United States, 

References & Publications (6)

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.neuropsy — View 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 — View 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. — View 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. — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of software as a medical device for the assessment of current major depressive episodes.	Evaluation of patient objective and subjective measures to develop algorithm to determine whether the patient is experiencing a current major depressive episode.	24 months