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Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
NCT05566769 · View on ClinicalTrials.gov ↗
Study Summary
NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.
Conditions Studied
Interventions
- DEVICE NMOSDCopilot smartphone application
Study Locations (20)
Other
- Hôpital Roger Salengro — Lille
- CHU Marseille - La Timone — Marseille
- CHU de Montpellier — Montpellier
- Hopital Pasteur 2 — Nice
- Hopital La Pitié Salpétrière — Paris
- CHU Rouen — Rouen
- Hopital de Hautepierre — Strasbourg
- CHU Toulouse - Hôpital Purpan — Toulouse
- Universitätsklinikum Carl Gustav Carus — Dresden
- Universitätsklinik Essen — Essen
California
- University of Southern California — Los Angeles
- University of California Davis Health — Sacramento
Florida
- University of south Florida — Tampa
Illinois
- NorthShore University HealthSystem — Evanston
Maryland
- Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center) — Baltimore
Massachusetts
- Massachussets General Hospital — Boston
Missouri
- Washington University in St. Louis — Washington
Nevada
- CC Lou Ruvo Center for Brain Health — Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2023-11-03 |
| Est. Completion | 2026-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05566769
The ClinicalTrials.gov registry entry for NCT05566769 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ad scientiam, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neuromyelitis Optica appearing as the primary indexed condition, and to 1 intervention — of which NMOSDCopilot smartphone application is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05566769 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05566769 about?
NCT05566769 is a clinical study titled "Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD". NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-ba...
What is the current status of trial NCT05566769?
This trial is currently recruiting. It is a NA study. The enrollment target is 103 participants. The study started on 2023-11-03. Estimated completion is 2026-09.
What conditions does trial NCT05566769 study?
This clinical trial studies the following conditions: Neuromyelitis Optica. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05566769?
The interventions under investigation include: NMOSDCopilot smartphone application (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05566769?
This trial is sponsored by Ad scientiam, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05566769 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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