Sleep DisorderSADBNCT04232267
Analysis of Sleep Study Data to Assess Depressive Burden
An observational study of Sleep Disorder and Depressive; Behavioral Disorder, run by Medibio Limited at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disorder, Depressive; Behavioral Disorder, Mood Disorders
- What is being tested?
- MEB-001
- Type of treatment
- Medical device
- How many people
- 329 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jan 2020to 1 Mar 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subject has a pacemaker.
- Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Restore Sleep Clinic
Blaine, Minnesota, 55434
Ohio Sleep Solutions
Columbus, Ohio, 43214
Ohio Sleep Solutions
Grove City, Ohio, 43123
Ohio Sleep Solutions
Hilliard, Ohio, 43026
Lakeland Sleep and CPAP
Plymouth, Minnesota, 55441
About this study
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)
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).
Read the 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.
- Being tested
- MEB-001
- Medical subject headings
- Sleep Wake Disorders, Mental Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEB-001Device
Software medical device used to aid in the screening of patients with potential depressive burden symptoms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MEB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report assists in the detection of clinically significant depressive burden.
Utilize PSG data and BDI-II to determine clinical depressive burden.
Measured: The study consists of 1 study visit (baseline).
Evaluate algorithm accuracy, sensitivity and specificity.
Sensitivity: True Positive/BDI-II + (the percentage of BDI-II positives identified by MEB-001) Specificity: True Negative/BDI-II - (the percentage of BDI-II negatives identified by MEB-001)
Measured: The study consists of 1 study visit (baseline).
Secondary outcomes (2)
Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.
Positive predictive value: True Positive/MEB-001 + (the percentage of MEB-001 positive test results that agree with BDI-II) Negative predictive value: True Negative/MEB-001 - (the percentage of MEB-001 negative test results that agree with BDI-II)
Measured: The study consists of 1 study visit (baseline).
System reliability and internal consistency.
The MEB-001 is able to assess clinically depressive burden compared to the BDI-II
Measured: The study consists of 1 study visit (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Jan 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medibio Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Bruner, Study director, Medibio LimitedArchie Defillo, MD, Study chair, Medibio LimitedArchie Defillo, MD, Principal investigator, Medibio Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232267
- Sponsor's protocol ID
- CIP-0018
- Acronym
- SADB
- Status last verified
- Dec 2023
- First submitted
- 7 Jan 2020
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04232267
- Acronym / sponsor ID
- SADB / CIP-0018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Medibio LimitedIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 18 Jan 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients prescribed Polysomnology (PSG - sleep study) | – | Device: MEB-001Patients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject has a pacemaker.
- Subject is suspected or known to have active alcohol or drug abuse (including but not limited to abuse of marijuana).
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-001Software medical device used to aid in the screening of patients with potential depressive burden symptoms. | Device | Patients prescribed Polysomnology (PSG - sleep study) |
Primary outcome
Report assists in the detection of clinically significant depressive burden.
Time frame: The study consists of 1 study visit (baseline).
Utilize PSG data and BDI-II to determine clinical depressive burden.
Evaluate algorithm accuracy, sensitivity and specificity.
Time frame: The study consists of 1 study visit (baseline).
Sensitivity: True Positive/BDI-II + (the percentage of BDI-II positives identified by MEB-001) Specificity: True Negative/BDI-II - (the percentage of BDI-II negatives identified by MEB-001)
2 secondary outcomes
Evaluate positive predictive value and negative predictive value in detecting clinically significant depressive burden.
Time frame: The study consists of 1 study visit (baseline).
System reliability and internal consistency.
Time frame: The study consists of 1 study visit (baseline).
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 21 Dec 2023.
- Individual participant dataSharing planned: No. There is no plan to share the participant data to other researchers.
Related trials for Sleep Disorder
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
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.
Melissa Bruner study director
Medibio Limited
Archie Defillo, MD study chair
Medibio Limited
Archie Defillo, MD principal investigator
Medibio Limited
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Depressive; Behavioral Disorder, run by Medibio Limited at 5 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 5 inclusion and 2 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 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Report assists in the detection of clinically significant depressive burden. (time frame: The study consists of 1 study visit (baseline).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2023.