Clinical trials: Digital
Pulmonary Disease, Chronic Obstructive
TARA Working Prototype [Version 2]: Feasibility Study
TARA is a Digital Behaviour Change Intervention (DBCI) for Individuals with COPD (IwCOPD), which has been designed using a Human-Centred Design (HCD) methodology.
- Trial name
- NCT04320524
- Testing
- Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention
- Sponsor
- Boehringer Ingelheim
Reconstructive Surgical Procedures, Plastic Surgery
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Trial name
- IMED-GLOW800 (NCT07164040)
- Testing
- The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
- Where
- 3 sites in Portugal, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Diabetes Mellitus, Type 2
Digital Therapeutic Based Investigation to Improve Glycemic Control in Patients With Type 2 Diabetes and Residual Hyperglycemia on Stable Medical Therapy
Randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that BT-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their…
- Trial name
- BRIGHT (NCT05266625)
- Testing
- BT-001, Control App
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Better Therapeutics
Mental Health Strategies, School Mental Health Services
Assist MH Digital Technologies to Support School Mental Health Care
The goal of this SBIR is to develop and test Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer SMH treatment resources to help providers implement a more customized treatment plan…
- Conditions
- Mental Health Strategies, School Mental Health Services, Digital Technologies, Technology Development
- Trial name
- ASSIST-MH (NCT06728683)
- Testing
- ASSIST-MH
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- 3-C Institute for Social Development
Alzheimer Disease, Preclinical Alzheimer's Disease
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - PAST Extension
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on…
- Conditions
- Alzheimer Disease, Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer's Disease (Incl Subtypes)
- Trial name
- AMYPRED-PAST (NCT04851496)
- Where
- 4 sites in United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Novoic Limited
Learning Disorders, Specific, Learning Disabilities
Examining the Effect of a Digital Medical Device for Cognitive and Musical Training in Children With Reading Disabilities
The goal of this clinical trial is to assess the effect on reading skills of the digital medical device Poppins Clinical for cognitive and musical training in pediatric participants (ages 7-11) with a specific learning disability…
- Conditions
- Learning Disorders, Specific, Learning Disabilities, Specific Learning Disorder, With Impairment in Reading, Dyslexia
- Trial name
- POPPINS-CE (NCT06596980)
- Testing
- Poppins Clinical
- Where
- France
- Volunteers
- 38 people
- Sponsor
- Poppins
Aging
Health in Motion Pragmatic Clinical Trial - WRAPAROUND
Falls among older adults are a serious public health concern, and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden.
- Trial name
- NCT06619496
- Testing
- Human-led fall prevention program, Avatar-led fall prevention program
- Where
- United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Blue Marble Rehab Inc
Diabetes Mellitus, Type 2, Diabetic Complication
mHealth Titration and Management
The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to…
- Trial name
- NCT03908762
- Testing
- iSage App with connected glucometer, Magnet
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Amalgam Rx, Inc.
Cystic Fibrosis
Continuous Cardiorespiratory Monitoring in Cystic Fibrosis
Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is characterized by pulmonary exacerbations (PEx).
- Trial name
- NCT04489186
- Testing
- Wearable device
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Byteflies
Mouth Diseases
Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™
The purpose of this study is to validate the ability of the STRATICYTE™ predictive model to predict the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC) in a retrospective…
- Trial name
- NCT05853783
- Testing
- STRATICYTE™ Test
- Where
- 5 sites in United States
- Volunteers
- 180 people
- Sponsor
- Proteocyte Diagnostics Inc.
Orthodontic Brackets
Digital Bonding vs. Direct Bonding Study
This is a prospective, 2-armed, randomized, multi-site clinical study to demonstrate that digital bonding is a more efficient treatment method than direct placement of brackets.
- Trial name
- NCT06266130
- Testing
- Treatment Group Digital Bonding Tray, Control Group Direct Bonding
- Where
- 5 sites in United States
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Solventum Orthodontics Corporation
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Digital Ulcers, Systemic Sclerosis
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo.
- Trial name
- RAPIDS-2 (NCT00077584)
- Testing
- Bosentan 62.5 mg, Bosentan 125 mg
- Volunteers
- 188 people
- Sponsor
- Actelion
Mild Cognitive Impairment
Five Lives MED to Improve Cognitive Function in Mild Cognitive Impairment
The goal of this randomized controlled trial is to determine whether the digital health app Five Lives MED can improve cognitive function in people with mild cognitive impairment (MCI).
- Trial name
- NCT06598163
- Testing
- Five Lives MED
- Where
- 7 sites in France, United Kingdom
- Volunteers
- 170 people
- Sponsor
- SharpTx
Depression Chronic, Depressed
Evaluation of Dalia Solution For Depressed Patient
The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive…
- Conditions
- Depression Chronic, Depressed, Depressed Mood, Depression and Quality of Life
- Trial name
- DaliaMonitorin (NCT07211984)
- Testing
- Dalia Monitoring, Conventional healthcare
- Where
- France
- Volunteers
- 644 people
- Sponsor
- Dalia Care
Skin Cancer Melanoma
AI-Driven Early Detection of Skin Cancer
This study evaluates the feasibility and accuracy of an AI-powered mobile platform (NuvanaDx) for early detection of skin cancer, including melanoma, using smartphone-based imaging.
- Trial name
- Skin Cancer (NCT07144306)
- Testing
- Smartphone-based AI skin lesion analysis (NuvanaDx platform).
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nuvana Healthcare LTD
Pregnancy Related, Mental Health Issue
MamaConecta: Digital Tool for Maternal Mental Health
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period.
- Conditions
- Pregnancy Related, Mental Health Issue, Postpartum Depression, Postpartum Anxiety
- Trial name
- DDT (NCT06442774)
- Testing
- Mobile application, Monitoring via wearable
- Where
- 3 sites in Spain
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- A Thousand Colibris, S.L
Myopia
MyopiaX Treatment for the Reduction of Myopia Progression in Children and Adolescents: Safety and Efficacy Investigation
The purpose of this trial is to investigate the safety and efficacy of MyopiaX - a digital treatment intended to slow the progression of myopia in children and adolescents.
- Trial name
- MyopiaX-1 (NCT04967287)
- Testing
- MyopiaX, Myopia control spectacles
- Where
- 10 sites in Germany, Netherlands and 3 more
- Volunteers
- 124 people
- Sponsor
- Dopavision GmbH
Skin Cancer, Dermatology/Skin - Other
Utility of Digital Dermoscopy in the Skin Cancer Clinic
This feasibility study aims to evaluate the use of the BARCO NV digital dermatoscope (non-CE marked device) in the skin cancer clinic.
- Trial name
- NCT03497455
- Testing
- Barco NV Digital Dermatoscope device images, Standard medical photographs including dermoscopy images, Clinic proforma completion
- Where
- United Kingdom
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Barco NV
COPD
Validation of a Digital Platform for Functional Respiratory Rehabilitation
Chronic Obstructive Pulmonary Disease (COPD), characterized by persistent airflow limitation in the respiratory airways, is a chronic condition that affects millions of people worldwide.
- Trial name
- ReHub (NCT06252818)
- Testing
- ReHub
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Bio-Sensing Solutions S.L. (DyCare)