Depressive EpisodeSAMDENCT05708222
Sleep Signal Analysis for Current Major Depressive Episode (SAMDE)
An observational study of Depressive Episode and Depression, run by Medibio Limited at 13 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Depressive Episode, Depression, Depressive Disorder
- What is being tested?
- MEB-001
- Type of treatment
- Medical device
- How many people
- 715 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Sep 2022to 9 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Subjects must meet ALL the following conditions to be eligible to participate in the study:
- Subject is age ≥ 22 years and ≤ 75 years.
- Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
- Subject is willing and able to provide informed 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 diagnostic PSG study, as prescribed.
Who cannot join
- Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:
- Subject has a pacemaker.
- Subject has undergone a heart transplant.
- Subject is undergoing a full night C-PAP titration study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Comprehensive Sleep Medicine Associates
Austin, Texas, 78757
Lakeland Sleep Store
Blaine, Minnesota, 55449
Medbridge Healthcare
Bradenton, Florida, 34205
Medbridge Healthcare
Clayton, North Carolina, 27520
Ohio Sleep Solutions
Columbus, Ohio, 43004
Ohio Sleep Solutions
Grove City, Ohio, 43123
Medbridge Healthcare
North Charleston, South Carolina, 29406
Lakeland Sleep
Plymouth, Minnesota, 55441
Medbridge Healthcare
Raleigh, North Carolina, 27612
Comprehensive Sleep Medicine Associates
Sugar Land, Texas, 77478
Medbridge Healthcare
Sumter, South Carolina, 29150
Comprehensive Sleep Medicine Associates
The Woodlands, Texas, 77381
Medbridge Healthcare
Wilson, North Carolina, 27822
About this study
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.
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.
Read the 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.
- Conditions
- Depressive Episode, Depression, Depressive Disorder, Depressive Disorder, Major, Depression Mild
- Being tested
- MEB-001
- Keywords
- Major Depressive Episodes, Depression, Sleep Study
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEB-001Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Self Reported Assessment | This group of patients will self report their answers to the MINI assessment. Receives: Device: MEB-001 | |
| Clinician Interview Assessment | This group of patients will complete the MINI assessment via an interactive interview conducted by a qualified clinician. Receives: Device: MEB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Sep 2022
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medibio Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Archie Defillo, MD, Study chair, Medibio LimitedMelissa E Bruner, MS, Study director, Medibio Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708222
- Sponsor's protocol ID
- CIP-0089
- Acronym
- SAMDE
- Status last verified
- Jul 2024
- First submitted
- 25 Sep 2022
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35489559Caldirola 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.
PubMed 35306830Perna 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.
PubMed 33338557Dacco 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.
PubMed 36644846Perna 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.
PubMed 32160691Perna 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.
PubMed 33065816
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05708222
- Acronym / sponsor ID
- SAMDE / CIP-0089
- Conditions
- Depressive Episode, Depression, Depressive Disorder, Depressive Disorder, Major, Depression Mild
- Keywords
- Major Depressive Episodes, Depression, Sleep Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Medibio LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Reported Assessment | – | Device: MEB-001This group of patients will self report their answers to the MINI assessment. |
| Clinician Interview Assessment | – | Device: MEB-001This group of patients will complete the MINI assessment via an interactive interview conducted by a qualified clinician. |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Subjects must meet ALL the following conditions to be eligible to participate in the study:
- Subject is age ≥ 22 years and ≤ 75 years.
- Subject is undergoing polysomnography due to suspected primary or secondary sleep disorders.
- Subject is willing and able to provide informed consent.
- Subject has the ability to read and understand the instructions for the study.
Key exclusion criteria (4 listed)
- Subjects will not be eligible, and they will not be recruited to participate in the study if any of the following conditions are present:
- Subject has a pacemaker.
- Subject has undergone a heart transplant.
- Subject is undergoing a full night C-PAP titration study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEB-001The 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. | Device | Clinician Interview Assessment, Self Reported Assessment |
Primary outcome
Development of software as a medical device for the assessment of current major depressive episodes.
Time frame: 24 months
Evaluation of patient objective and subjective measures to develop algorithm to determine whether the patient is experiencing a current major depressive episode.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 35489559Caldirola 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.
- Results publication: PubMed 35306830Caldirola 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.
- Results publication: PubMed 33338557Perna 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.
- Results publication: PubMed 36644846Dacco 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.
- Results publication: PubMed 32160691Perna 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.
- Results publication: PubMed 33065816Perna 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Archie Defillo, MD study chair
Medibio Limited
Melissa E Bruner, MS study director
Medibio Limited
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Episode and Depression, run by Medibio Limited at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of software as a medical device for the assessment of current major depressive episodes. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05708222, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.