Clinical trials: Wearable Devices
Atrial Fibrillation, Arrhythmias, Cardiac
Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for the automatic identification of atrial…
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases
- Trial name
- Core AF (NCT04464499)
- Testing
- ECG measurement
- Where
- 2 sites in France
- Volunteers
- 160 people
- Sponsor
- Withings
Obstructive Sleep Apnea
Skiin-PSG Sleep Apnea
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the…
- Trial name
- NCT06247878
- Testing
- Skiin underwear chest band
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Cystic Fibrosis
A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis
This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design.
- Trial name
- NCT04923464
- Where
- 17 sites in United States, United Kingdom
- Volunteers
- 51 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Depression / Major Depressive Disorder, Depressed Mood
REM Sleep Disruption and Its Potential Uses in Depression Management
This randomized study evaluated whether brief wrist vibrations delivered through an Apple Watch during algorithm-identified rapid eye movement (REM) sleep could reduce depressive symptoms over approximately four weeks.
- Trial name
- NCT07891806
- Testing
- REM-Contingent Smartwatch Haptic Stimulation, Smartwatch Sleep Monitoring and Smart Alarm
- Where
- 2 sites in Romania
- Volunteers
- 208 people
- Sponsor
- WAKEZ HEALTH TECH ECOSYSTEM SRL
Alzheimer's Disease
Memesto Wearable Repetitive Message and Music Therapy Device Music Therapy Device That Senses and Reduces Agitation in People With AD,
This is a 12-week proof-of-concept study to evaluate the efficacy of Memesto in reducing agitation in persons with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) currently living in a residential care…
- Trial name
- AWARD (NCT06596278)
- Testing
- Memesto
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Edgewater Safety Systems, Inc.
Electrocardiography (ECG), Photoplethysmography
Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)
This observational study will collect synchronized photoplethysmography (PPG) and electrocardiogram (ECG) recordings from approximately 50 healthy adult volunteers.
- Conditions
- Electrocardiography (ECG), Photoplethysmography, Healthy Volunteers
- Trial name
- ILECS-ECGPPG (NCT07684807)
- Testing
- Corsano CardioWatch 287-2, VivaLNK wearable ECG patch
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Corsano Health B.V.
Influenza, Human, COVID-19
Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections
The goal of this decentralized, observational study is to enroll and observe adults in the contingent United States during the 2023-2024 flu season.
- Conditions
- Influenza, Human, COVID-19, Influenza A, Influenza B
- Trial name
- WAVE (NCT06207929)
- Where
- United States
- Volunteers
- 18,157 people, healthy volunteers welcome
- Sponsor
- Evidation Health
Chronic Obstructive Pulmonary Disease, Dyspnea
A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study
The goal of this exploratory clinical trial is to evaluate the initial clinical safety and performance of a prototype wearable chest wall vibration (CWV) device intended to relieve exertional dyspnea in adults with Chronic…
- Trial name
- ResWave (NCT06432920)
- Testing
- ResWave
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- Elevre Medical Ltd.
Blood Pressure Monitoring, Ambulatory
Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)
The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals.
- Trial name
- COR-BP (NCT07633886)
- Testing
- Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2, Auscultatory blood pressure measurement
- Volunteers
- 170 people
- Sponsor
- Corsano Health B.V.
PHYSIOLOGICAL PHENOMENA, Homeostasis
Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)
TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin.
- Conditions
- PHYSIOLOGICAL PHENOMENA, Homeostasis, Physical Functional Performance, Cardiorespiratory Fitness
- Trial name
- TRU-OMNIBODY (NCT07805044)
- Testing
- Standardized Physiologic Resilience Challenge, Multimodal Whole-Body Physiologic Monitoring, Research-Only Whole-Body Digital Twin Analysis
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Opioid Use Disorder, Opioid Withdrawal
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use…
- Conditions
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- Trial name
- IBO-CARE (NCT07871877)
- Testing
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Clive Michelsen
Biomarkers, Acute Kidney Injury
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
The goal of this observational study is to understand whether a wearable sensor (the Nutromics Sensor Device) can accurately measure drug and biomarker levels in the fluid just under the skin (interstitial fluid), instead of…
- Conditions
- Biomarkers, Acute Kidney Injury, Sepsis
- Trial name
- VENTURE (NCT07893223)
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Nutromics
Pulmonary Disease, Chronic Obstructive
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational…
- Trial name
- NCT02619357
- Testing
- SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Chronic Obstructive Pulmonary Disease (COPD)
Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.
This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard™ (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of…
- Trial name
- NCT05119374
- Testing
- SenseGuard Investigational Device
- Where
- 6 sites in Israel
- Volunteers
- 57 people
- Sponsor
- NanoVation
Trichotillomania
Feasibility Study for Treating Trichotillomania With Wearable Device and App System
Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop.
- Trial name
- NCT04241120
- Testing
- Device and app system designed for participant to self-administer Habit Reversal Training, Reminder bracelet control condition
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- HabitAware Inc.
Osteopenia
Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities.
- Trial name
- NCT03688282
- Testing
- Wearable vibration belt
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Theranova, L.L.C.
Healthy Adult Participants, Gut Microbiomes
DORA - A Study Using Digital Health Tools/Platform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals
The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital…
- Conditions
- Healthy Adult Participants, Gut Microbiomes, AI
- Trial name
- DORA (NCT07575529)
- Testing
- Synbiotic Nutritional Product
- Where
- Singapore
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Respiratory Disease
Feasibility of Remote Evaluation and Monitoring of Acoustic Pathophysiological Signals With External Sensor Technology
The aim of this study is to explore the acceptability and feasibility of a novel medical device system for remote monitoring of breath and heart sounds (replicating remotely, and in an easy-to-use garment, that which a clinician…
- Trial name
- REMAP-WEST-FEA (NCT04693091)
- Testing
- Senti V1.0 Device
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Senti Tech Ltd
Heart Failure
Remote Monitoring and Optimization of Heart Failure Therapy
Heart failure is a condition in which the heart cannot pump blood effectively, often leading to symptoms such as shortness of breath and fluid retention.
- Trial name
- REMODEL-HF (NCT07622472)
- Testing
- Wearable Monitoring Device for Heart Failure
- Where
- 9 sites in France, Germany and 7 more
- Volunteers
- 800 people
- Sponsor
- Zoll Medical Corporation
Osteoarthritis, Knee
A Telehealth Study of a Wearable Electroceutical & Sports Sleeve for Knee Osteoarthritis Pain Relief & Improved Function
The purpose of this telemedicine 24-person open-label study is to evaluate the safety and usability of a proprietary wearable microcurrent electroceutical (a device that delivers micro-ampere electronic pulses) made by Healables…
- Trial name
- HEAL01WMCOA1 (NCT04938271)
- Testing
- HEAL-122 microcurrent electroceutical with e-textile sports knee sleeve
- Where
- Israel
- Volunteers
- 24 people
- Sponsor
- Healables Ltd.