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NCT05566769 · ClinicalTrials.gov registry record · NA
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD
A NA study of Neuromyelitis Optica, sponsored by Ad scientiam.
- Recruiting
- Registry status
- NA
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT05566769: Recruiting NA study of Neuromyelitis Optica, sponsored by Ad scientiam.
NCT05566769 is a NA study of Neuromyelitis Optica that is actively recruiting participants, run by Ad scientiam. The registered enrollment target is 103 participants, below the 499-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05566769, a NA study of Neuromyelitis Optica, is actively recruiting participants, sponsored by Ad scientiam.
- RECRUITING
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline
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 |
What NCT05566769 shows while recruiting
NCT05566769 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 499-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (79% lower).
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.
NCT05566769 names 20 study sites across 10 states, led by Other, California, Florida.
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.
What interventions are being tested in trial NCT05566769?
The interventions under investigation include: NMOSDCopilot smartphone application (DEVICE).
Who is sponsoring clinical trial NCT05566769?
This trial is sponsored by Ad scientiam, which has 5 total clinical trials registered on ClinicalTrials.gov.
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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