7 completed, 3 terminated, 3 unknown, 2 withdrawn. 13 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 13 | Completed 6, Terminated 3, Unknown 2, Withdrawn 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Performance Study of the Electroencephalographic Recording Device and Sound Emissions Memowave emitting sounds, Memowave not emitting sounds - Sleep Disorder | Not applicable | Withdrawn | BioSerenity | 2023-10-30 | 2023-10-24 | |
| Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA TOCONAUTE - Obstetrical Complications, Monitoring Injury of Scalp of Newborn | Not applicable | Completed | University Hospital, Lille | 60 | 2022-08-31 | 2025-12-08 |
| REtinal and VIsual Cortical Response in Early PSYchosis Retinaute (BioSerenity), EEG Headset 64 electrodes (BioSemi), MonPackOne (Metrovision) - Prodromal Schizophrenia, Psychotic Episode | Not applicable | Terminated | Centre Psychothérapique de Nancy | 34 | 2022-01-26 | 2024-08-22 |
| Study of Bipolar Disorders and Retinal Electrophysiological Markers EEG and ERG measurements (Retinaute®, BioSerenity), Actigraphy (Motion Watch 8®, CamNtech), Neuropsychological assessments - Bipolar Disorder | Not applicable | Terminated | Centre Psychothérapique de Nancy | 62 | 2022-01-18 | 2024-08-22 |
| Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital GOLDSTANDARD, NEURONAUTE - Epilepsy | Not applicable | Withdrawn | BioSerenity | 2020-12-20 | 2021-11-11 | |
| Adverse Myocardial and Vascular Side Effects of Immune Checkpoint Inhibitors Cardiac MRI, Smart cloth, Biobanking - Cancer, Immune Defect | Completed | Assistance Publique - Hôpitaux de Paris | 50 | 2020-11-06 | 2023-06-08 | |
| Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH) NIRS recording - Urinary Disorders, Urinary Incontinence | Not applicable | Completed | BioSerenity | 40 | 2020-07-07 | 2021-11-08 |
| Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation EIT - Respiratory Disease | Not applicable | Unknown | BioSerenity | 60 | 2020-02-15 | 2020-12-21 |
| PACIFIC-PRESERVED : PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study Extensive phenotyping - Heart Failure, Heart Failure With Preserved Ejection Fraction | Unknown | Assistance Publique - Hôpitaux de Paris | 175 | 2019-12-09 | 2024-03-28 | |
| Evaluation of the Signals Electrophysiological Measured by Intelligent Textiles test of sensors for somnonaute device, test of sensors for uronaute device, test of sensors for toconaute device - Healthy | Not applicable | Terminated | BioSerenity | 1 | 2019-11-29 | 2021-11-11 |
| evaluatioN de la perfOrMAnce De Capteurs E-textiles CARDIOSKIN - Short record, Cardioskin - long record, Neuronaute - long record - Healthy Volunteers Without Any Cardiac or Any Neurological Disorders | Not applicable | Unknown | BioSerenity | 100 | 2019-07-09 | 2019-11-13 |
| EVAluation of the Non Inferiority of Interpretability of Cardiokin Compared to Holter Cardioskin, Holter - Healthy Volunteers | Not applicable | Completed | BioSerenity | 39 | 2019-07-08 | 2020-01-22 |
| Collection of Information by Tocography External cardiotocograph, Toconaute, electrophysiological device (Micromed) - Pregnancy Related | Not applicable | Completed | BioSerenity | 35 | 2018-12-11 | 2021-11-08 |
| Clinical Trial Testing the BioSerenity Pulse Oximeter (EOXY) Efficacy, Performance and Safety in Healthy Volunteer EOXY device, Gold standard oximeter, SaO2 sampling - Healthy | Not applicable | Completed | BioSerenity | 13 | 2017-12-08 | 2021-01-12 |
| Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked Cardioskin, Neuronaute - Healthy | Not applicable | Completed | BioSerenity | 30 | 2017-10-16 | 2019-07-09 |
Bipolar Disorder (1) · Cardiotoxicity (1) · Cardiovascular Abnormalities (1) · Epilepsy (1) · Heart Failure (1) · Myocarditis (1) · Myositis (1) · Neoplasms (1) · Pericarditis (1) · Prodromal Symptoms (1) · Psychotic Disorders (1) · Respiration Disorders (1) · Schizotypal Personality Disorder (1) · Sleep Wake Disorders (1) · Urinary Bladder Diseases (1)
Actigraphy (1) · Electrocardiography, Ambulatory (1) · Electroencephalography (1) · Tomography, Optical Coherence (1)
France (13) · Belgium (1)
Charles Garabedian, MD,PhD (1) · Mariana Mirabel, MD (1)
PMID 35124236, PMID 36159928, PMID 37752365, PMID 38135173, PMID 40101837