Heart
3-lead ECG and heart rate, FDA-cleared. Heart rate variability for research.
Sleep in Clinical Research
The Hexoskin Medical System records ECG, breathing, and movement at home through the night, so sponsors can follow sleep and nighttime physiology between visits, over consecutive nights. Sleep and heart rate variability are research measures on the Hexoskin Medical System, recorded at home with the same garment as the FDA-cleared ECG, respiratory rate, and activity.
3-lead ECG and heart rate, FDA-cleared. Heart rate variability for research.
Respiratory rate, FDA-cleared. Tidal volume and minute ventilation for research.
Activity, FDA-cleared. Steps, body position, and sleep for research.
Hexoskin OneView, the participant app with ePROs, and secure data hosting.
Participants wear the shirt to bed and record at home, night after night, around visits and treatment changes. The Hexoskin Medical System keeps ECG, breathing, and movement on one clock with the ePROs, and sleep measures are derived for research, with quality indicators for each night. We help define the analysis windows and the nights the protocol needs before the first participant.
Every night recorded with the garment gives these measures, from the same ECG, breathing, and movement signals. Select a measure to read its definition.
Total sleep time is the time spent in any sleep phase during the night.
Show the DefinitionTotal sleep time is the time spent in any sleep phase during the night.
Sleep efficiency is the proportion of time in bed spent asleep.
Show the DefinitionSleep efficiency is the proportion of time in bed spent asleep.
Time to fall asleep, or sleep latency, runs from the start of the sleep recording to the first detected sleep phase.
Show the DefinitionTime to fall asleep, or sleep latency, runs from the start of the sleep recording to the first detected sleep phase.
Sleep phases show when the night moves between wake, REM, and non-REM sleep, with the distribution of each phase.
Show the DefinitionSleep phases show when the night moves between wake, REM, and non-REM sleep, with the distribution of each phase.
REM and non-REM time are the totals spent in each type of sleep, from sleep onset to the last awakening.
Show the DefinitionREM and non-REM time are the totals spent in each type of sleep, from sleep onset to the last awakening.
Wake time is the total time awake between sleep onset and the last awakening.
Show the DefinitionWake time is the total time awake between sleep onset and the last awakening.
Sleep position is the time spent on the back, the belly, each side, or upright.
Show the DefinitionSleep position is the time spent on the back, the belly, each side, or upright.
Recorded by the three-axis accelerometer in the recorder.
Position changes count how often the sleeping position changes during the night.
Show the DefinitionPosition changes count how often the sleeping position changes during the night.
Recorded by the three-axis accelerometer in the recorder.
Night heart rate gives the average, minimum, and maximum heart rate across the night, from the ECG.
Show the DefinitionNight heart rate gives the average, minimum, and maximum heart rate across the night, from the ECG.
Recorded by the textile ECG electrodes.
Night heart rate variability gives the high- and low-frequency HRV power recorded during sleep.
Show the DefinitionNight heart rate variability gives the high- and low-frequency HRV power recorded during sleep.
Recorded by the textile ECG electrodes.
Night breathing rate gives the breaths per minute and their range across the night, from both breathing bands.
Show the DefinitionNight breathing rate gives the breaths per minute and their range across the night, from both breathing bands.
Recorded by the thoracic and abdominal breathing bands.
Night activity is the movement intensity through the night, from the three-axis accelerometer.
Show the DefinitionNight activity is the movement intensity through the night, from the three-axis accelerometer.
Recorded by the three-axis accelerometer in the recorder.
Sleep measures are research outputs of the Hexoskin Medical System. They are not part of the FDA clearance.

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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Published studies show how teams recorded sleep at home and compared it with reference assessments.
Hexoskin overview of wearable physiological recording in clinical development studies.
Read the SourceResearch library. The Hexoskin and Astroskin publication library, searchable by research area and measurement.
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.
Download the White Paper
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 the indication, the population, and the nights the protocol needs. A clinical specialist will reply with the next step.