Clinical trials: Validation Studies
Sleep Apnea
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea.
- Trial name
- NCT03775291
- Testing
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- Where
- 6 sites in United States, Ireland
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
Healthy
Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed
The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population.
- Trial name
- NCT04268017
- Testing
- FeetMe Monitor
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- FeetMe
Clinical Indication for Brain MRI, Healthy Volunteers
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
- Trial name
- NCT05425927
- Testing
- SyMRI 15 (3D)
- Where
- 6 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- SyntheticMR
Dental Anxiety
Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM
The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (CEDAM) scales will be assessed in children aged 9-16 years using item analysis…
- Trial name
- MUSIC-CEDAM (NCT07350993)
- Testing
- Music Listening Intervention
- Where
- Turkey (Türkiye)
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Şevval Çakıcı
Parkinson Disease
Robotic Assessments of Hand Function in Patients With Parkinson's Disease
It has been shown that patients with Parkinson's disease (PD) have impaired kinaesthesia and haptic perception of the upper limbs.
- Trial name
- RHK Parkinson (NCT05245955)
- Testing
- Assessments of the hand sensory function with the ReHapticKnob
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Swiss Federal Institute of Technology
In Utero Drug Exposure
Validation of the In-utero Transmission of Probiotics
This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study.
- Trial name
- PROBIO (NCT04050189)
- Testing
- Natural products: Probiotics
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Obstructive Sleep Apnea
Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the…
- Trial name
- NCT03997916
- Testing
- Belun Ring, PSG
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Hypoxia
Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study.
- Trial name
- NCT06634693
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Osteoarthritis of the Small Joints of the Hand
Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability.
- Trial name
- NCT04678622
- Testing
- Bioferula3D
- Where
- 2 sites in Spain
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Optimus3D S.L.
Obstructive Sleep Apnea
Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients.
Derivation and Validation of a combination of BOSTON score and DES-OSA score to exclude OSA or to confirm OSA in patients.
- Trial name
- NCT03983564
- Testing
- Cutoff Validation
- Where
- Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Astes
Shoulder Pain
Shoulder Rating Questionnaire in Turkish
The purpose of this study is to determine the Turkish version of the Shoulder Rating Questionnaire (SRQ) and assign reliability and validity in Turkish patients.
- Trial name
- NCT04409756
- Testing
- shoulder rating questionnaire
- Where
- Turkey (Türkiye)
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Betül Tepeli
COVID-19
Bioaerosol Sampling Device (BSD) Clinical Study
The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be…
- Trial name
- NCT06047067
- Where
- 6 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Cantor BioConnect, Inc.
Minimally Invasive Surgery Basic Skills
Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)
Background: Laparoscopic surgical procedures have become increasingly established in operative medicine. They require special motor, haptic, and spatial-visual skills to perform the interventions safely and effectively.
- Trial name
- NOVICE (NCT03040544)
- Testing
- LTB-Curriculum, Laparoscopic cholecystectomy
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University Hospital Schleswig-Holstein
Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT)
Clinical Performance of SE-SPTM-PCR in Detecting Hcmv-miR-UL22A-5p After Hematopoietic Stem Cell Transplantation
This study aims to evaluate the clinical performance of a novel microRNA-based detection platform, SE-SPTM-PCR, for identifying cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (HSCT).
- Conditions
- Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), CMV Reactivation, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- Trial name
- SESPTM-CMV (NCT07181330)
- Testing
- SE-SPTM-PCR microRNA assay
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ting YANG
Breast Neoplasms
CT-AI Breast Cancer Opportunistic Screening Health Examination Study
This study evaluates the clinical utility of a locked chest CT artificial intelligence model for opportunistic breast cancer screening among women undergoing health examinations.
- Trial name
- NCT07809698
- Testing
- CT-AI-assisted breast cancer screening
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Healthy Subjects
Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects
Multicenter, Prospective, Non-Randomized clinical trial to define and validate normative data of EGJ-distensibility measurements and contractile patterns in healthy subjects.
- Trial name
- RUBY (NCT03831724)
- Testing
- EndoFLIP™ System with FLIP Topography Module
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Endoscopy
Endoscopy Quality Study
This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure.
- Trial name
- NCT03351790
- Testing
- Questionniare only
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
Carbapenem-Resistant Enterobacteriaceae
Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase…
- Trial name
- NCT03680898
- Testing
- Rectal swab collection
- Where
- 3 sites in United States, Canada
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Meridian Bioscience, Inc.
Range of Motion
KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study
The aim of the study is to investigate the validity and reliability of KinectROM application for objectively evaluating range of motion (ROM)
- Trial name
- KinectROM (NCT03731507)
- Testing
- Assessment of Range of Motion with Kinect Controller
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Saime Nilay Arman
Gonorrhea, Chlamydia
Cepheid Rectal Sample Validation Study
The purpose of this study is to validate Xpert CT/NG for the detection of CT and GC in rectal samples as part of the PA DOH and CLIA requirements.
- Conditions
- Gonorrhea, Chlamydia, Trichomonas
- Trial name
- NCT02099760
- Testing
- STD testing (GC/Ct/trich)
- Where
- 2 sites in United States
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh