Clinical trials: Wearable Technology
Healthy
Validation of Smart Garments for Gait Classification
The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig.
- Trial name
- NCT05898555
- Testing
- Skiin garment and pods
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Newborn Complication, Newborn Morbidity
Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya.
- Trial name
- NCT05728307
- Testing
- neoGuard vital signs monitor
- Where
- Kenya
- Volunteers
- 3,000 people
- Sponsor
- Assumpta Solome Nantume
Non-Small Cell Lung Cancer (NSCLC)
A Study To Monitor Lung Cancer Patients Activity And Assess Performance Status Through A Wearable Device.
The current research is a non-interventional (NIS) study seeking to support objective Performance Status (PS) assessments in the particular context of metastatic NSCLC adult patients. To do so, the study comprises two phases.
- Trial name
- Lupa-01 (NCT04751162)
- Testing
- Actigraphy device (wearable) and mobile application
- Where
- 10 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Hoffmann-La Roche
Chronic Pain
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain.
- Trial name
- NCT03299556
- Testing
- WHT
- Where
- United States
- Volunteers
- 420 people
- Sponsor
- Purdue Pharma LP
Atrial Fibrillation, Arrythmia, Cardiac
Validation Study of a Watch for the Detection of Atrial Fibrillation
The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).
- Trial name
- MOVE-ECG (NCT04041466)
- Testing
- AF detection by ECG
- Where
- 2 sites in France
- Volunteers
- 140 people
- Sponsor
- Withings
Obstructive Sleep Apnea
Developement of TipTraQ Home Sleep Test
The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and…
- Trial name
- NCT06474351
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
COPD
REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term…
- Trial name
- REMAPWESTFLARE (NCT05745155)
- Testing
- Senti Wear device system with Senti-AI subsystem
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Senti Tech Ltd
Hand Function, Stroke
TheraBracelet Phase I
This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.
- Conditions
- Hand Function, Stroke, Upper Extremity, Hemiparesis
- Trial name
- NCT03318341
- Testing
- Real Stimulation
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- TheraBracelet, Inc.
Ultrafiltration Failure
A Feasibility Study of Peritoneal Ultrafiltration With a Wearable Device, CLS UF, That Adds a Glucose-salt Solution to the Intraperitoneal Fluid in the Device, in Order to Maintain a Stable Intraperitoneal Osmolarity and Thereby Enhance Ultrafiltration.
The study is a proof-of-concept, a feasibility study of peritoneal ultrafiltration with a wearable device, Carry Life System Ultrafiltration (CLS UF) and will be performed on 4-6 stable peritoneal dialysis (PD) patients without…
- Trial name
- NCT03128073
- Testing
- Carry life system, ultrafiltration (CLS UF)
- Where
- Sweden
- Volunteers
- 5 people
- Sponsor
- Triomed AB
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, VGH
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06474390
- Where
- Taiwan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Hyperthyroidism, Graves Disease
AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease
Graves' disease is the most common cause of hyperthyroidism and is usually treated with antithyroid drugs such as methimazole (MMI).
- Conditions
- Hyperthyroidism, Graves Disease, Thyrotoxicosis
- Trial name
- NCT07857421
- Testing
- Glandy HYPER (AI-based monitoring software), Methimazole
- Where
- 2 sites in Germany
- Volunteers
- 30 people
- Sponsor
- THYROSCOPE INC.
Migraine
Nerivio Efficacy Under High-Frequency Use
This is a Post-marketing study investigating the impact of frequant usage with Nerivio on the safety profile of Remote Electrical Neuromodulation (REN) for the treatment of migraine.
- Trial name
- NCT07336056
- Testing
- Nerivio (REN device)
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Theranica
High Blood Pressure
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Rationale: Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor long-term blood pressure.
- Trial name
- BPTreat (NCT06508619)
- Testing
- Corsano CardioWatch 287-2 non-invasive blood pressure (NIBP) monitoring
- Where
- Netherlands
- Volunteers
- 80 people
- Sponsor
- Corsano Health B.V.
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
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.
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