Clinical Trial Data Collection
Add continuous physiology between study visits, at home or across sites, with participant support, compliance tracking, and data review built into the protocol.
Explore Trial SupportClinical Research & Development
Cardiac, respiratory, activity, and sleep measures, recorded continuously at home and on one clock. Hexoskin works with sponsors, CROs, and investigators to define candidate digital endpoints, develop biomarkers, and run wearable data collection in clinical trials.
The Hexoskin Medical System enters a program wherever continuous, objective data between visits helps: in the trial itself, in measure development, in data science, and in study delivery.
Add continuous physiology between study visits, at home or across sites, with participant support, compliance tracking, and data review built into the protocol.
Explore Trial SupportPlan equipment, training, logistics, and reporting with the study team, from feasibility work to multisite delivery.
Explore Study SupportTurn synchronized raw signals into features, models, and traceable outputs, with quality indicators and annotations kept alongside the data.
Explore AI & AnalysisCharacterize autonomic, respiratory, and sleep phenotypes, then specify each candidate measure, its analysis window, and its context of use before it informs a decision.
Explore Biomarkers
FDA 510(k) Cleared · Available for Research
Cardiorespiratory monitoring that patients wear like everyday clothing. The Hexoskin Medical System (HMS) records, displays, and stores 3-lead ECG, heart rate, respiratory rate, and activity, at home or in a healthcare facility, with textile sensors instead of adhesive electrodes.
For research, the HMS recorder and shirt can be configured to follow participants living with cardiovascular, respiratory, neurological, sleep, oncology, and rare conditions, day and night, with as little burden as possible.
The FDA clearance covers the recording, display, and storage of three-lead ECG, heart rate, respiratory rate, and activity in adults, as described in K243981. The research configuration and its derived measures are for research use and are not part of the clearance. HMS does not produce alarms, is not intended for real-time patient monitoring, does not provide automatic analysis or diagnosis, is not an apnea monitor, and is not intended for use with a pacemaker or as life-supporting equipment for critical care patients.
Tell us about the protocol, the population, and the setting. Our clinical team will reply with the configuration, the measures, and the next step for your program.
Every output the Hexoskin Medical System records or computes. Select a card to read its unit and definition, filter by data group or measurement area, or search for a measure.
Shirt and recorder for continuous cardiac, respiratory, and movement recording, with textile sensors and no adhesive electrodes.
3 outputs with definitions
Heart rate: average over the last 16 heart beats.
RR interval: time between two heart beat detections, calculated for every QRS event. Saved at the center of the QRS complex.
NN interval: Time between two heart beat detections, calculated for every QRS event.
Energy Expenditure Estimate: Total energy based on ECG, using the Mifflin and Keytel equation. Adjusted for the weight, height, sex, HRmax and HRmin of the user.
7 outputs with definitions
Heart rate status: quality of the heart rate signal.
QRS status: status of the last QRS detection.
6 outputs with definitions
13 outputs with definitions
6 outputs with definitions
2 outputs with definitions
Breathing rate: calculated over the last 7 respiration cycles.
Inspiration: detection of an inspiration onset event.
Expiration: detection of an expiration onset event.
Minute Ventilation: Volume of air per minute inspired in the last 7 complete respiration cycles. Based on the raw signal; for study reporting use minute_ventilation_adjusted.
Minute Ventilation, Adjusted: Volume of air per minute inspired in the last 7 complete respiration cycles, adjusted for the user profile.
Tidal Volume: Volume of air inspired in the last inspiration. Based on the raw signal; for study reporting use tidal_volume_adjusted.
Tidal Volume, Adjusted: Volume of air inspired in the last inspiration, adjusted for the user profile.
Breathing rate status: quality of the breathing rate signal.
5 outputs with definitions
8 outputs with definitions
8 outputs with definitions
Respiration Coefficient: Calculated from the adjusted minute ventilation and the adjusted tidal volume. Reflects the O2 input and CO2 output of the user.
Volume Expired: Maximum expired volume, standard test.
Acceleration: three-axis sensor with a 0.004 g resolution.
Activity: signal based on the accelerometer intensity vector.
Cadence: averaged over the last 7 strides, based on the accelerometer.
Step: the number of steps since the beginning of a recording.
Device position: gives the onset of a position change.
4 outputs with definitions
4 outputs with definitions
Steps: Number of steps detected for that range (activity) or record.
Sleep phase: gives the onset of a sleep phase change.
Sleeper position: gives the onset of a position change.
8 outputs with definitions
7 outputs with definitions
Duration: Total duration of the range (activity or time range) or record.
Recorded Time: Number of heart rate samples at 1 Hz, that is, the number of seconds of signal stored on the server.
VO2 max: Estimation of maximum rate of oxygen consumption measured during a maximal aerobic exercise based on distance traveled. Can be calculated by completing the fitness test “12 minutes Run Fitness Test” on Hexoskin OneApp.
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One recording carries cardiac, respiratory, activity, and sleep measures on the same clock. These are examples of candidate measures; none is a validated endpoint by default, and each needs analytical and clinical validation for its own context of use.
Seizure detection and forecasting research, post-ictal recovery, and nocturnal risk factors such as sleep position.
Published Examples
COPD and asthma programs that follow breathing pattern, ventilation, cough, and activity between visits.
Published Examples
Small cohorts that benefit from dense, repeated measures of autonomic regulation, breathing, sleep, and daily activity.
Published Examples
Sleep continuity and architecture recorded at home over consecutive nights, with the method compared against a reference.
Published Examples
Daily-life breathing, autonomic, and activity measures examined alongside momentary assessments of mood and behavior.
Published Examples
Recovery, treatment tolerance, and quality of life, with heart rate variability, activity, and sleep collected alongside patient-reported outcomes.
Published Examples
Heart rate, rhythm, variability, recovery, and activity in daily life, specified for the population and the decision at hand.
Candidate Measures
Specified with the study team for the population and the decision at hand.
1
Synchronize the ECG, respiratory, and movement signals, apply quality indicators, and document artifact handling before features are computed.
2
Build features and models for sleep, autonomic, and respiratory measures, with personal baselines and contextual annotations where the protocol needs them.
3
Lock the processing for the protocol, report results to the study team, and keep every output traceable to the raw recording.
Study planning, project management, coordination with sponsors, CROs, and sites, and training for site staff and participants.
Sensor and device management, shipping and handling, replacements, documentation, and technical support.
The Hexoskin OneView dashboard and the participant app, with questionnaires, annotations, and data extraction on the same clock as the recording.
Compliance and data-quality reporting, ad hoc reports, statistical analysis, and endpoint reporting for the study team.
These studies show how continuous physiological recordings have been used in clinical populations. Each result belongs to its own population, setting, and method; a candidate measure still needs validation for its intended context of use.
Forty-two adults with epilepsy wore the shirt during hospital video-EEG monitoring; ECG and accelerometer features were used to detect focal-to-bilateral tonic-clonic seizures.
Read the SourceAcross 304 inpatient nights from 47 people with epilepsy, lower sleep efficiency was associated with greater odds of a seizure in the following 24 hours.
Read the SourceAbstract and poster · European Respiratory Journal · 2017. Minute ventilation, tidal volume, breathing frequency, and inspiratory capacity were compared with a pneumotachograph in 16 men with COPD at rest and during stair stepping.
Read the SourceIn a crossover trial in girls aged 6 to 12 with Rett syndrome, Hexoskin contributed daily activity, sleep, heart, and lung-function data as exploratory measures.
Read the SourceA sleep-classification algorithm using ECG, respiratory movement, and accelerometry was evaluated against polysomnography in young healthy adults.
Read the SourceAdults with remitted major depression or no psychiatric history wore the shirt for seven days; breathing rate and minute ventilation predicted later positive affect.
Read the SourceBackground reading on continuous physiological monitoring in this field. Each paper is a free download.

Missing data weakens clinical trial conclusions. This paper shows where data loss comes from and how continuous recording between visits limits it when visits are missed or participants drop out.
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The burden of chronic obstructive pulmonary disease, and how continuous respiratory recording supports telemonitoring programs and patient follow-up between visits.
Download the White Paper
A review of the techniques used to measure breathing, the growing range of digital health devices, and the role of scientific validation when selecting a wearable for respiratory monitoring.
Download the White PaperTell us about the indication, the population, the study phase, and the measures you are considering. We will review them against what the platform records and reply with the next step.