Sleep in Clinical Research

Bring Nighttime Physiology Into the Protocol

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.

Heart

3-lead ECG and heart rate, FDA-cleared. Heart rate variability for research.

Breathing

Respiratory rate, FDA-cleared. Tidal volume and minute ventilation for research.

Activity & Sleep

Activity, FDA-cleared. Steps, body position, and sleep for research.

Study Platform

Hexoskin OneView, the participant app with ePROs, and secure data hosting.

Consecutive Nights at Home

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.

Sleep Measures in the Research Configuration

Every night recorded with the garment gives these measures, from the same ECG, breathing, and movement signals. Select a measure to read its definition.

Sleep measures are research outputs of the Hexoskin Medical System. They are not part of the FDA clearance.

The Hexoskin Medical System

Woman wearing the white Hexoskin Medical System shirt with its front zipper

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.

Designed for Continuous Wear

  • A front zipper, so the shirt goes on and comes off without being pulled over the head
  • Textile sensors located on the chest and the abdomen, with no adhesive electrodes on the skin
  • Light, soft fabric that stays comfortable through the day and the night, in men’s and women’s sizes
  • Recording starts when the recorder is connected, with up to 72 hours per charge and 600 hours of storage

What the FDA Clearance Covers

  • FDA 510(k) K243981, cleared November 18, 2025, Class II (21 CFR 870.2920)
  • Recording, display, and storage of 3-lead ECG, heart rate, respiratory rate, and activity
  • Used on the order of a licensed medical professional, for adult patients, as an aid to diagnosis and treatment
  • Three-lead ECG indicated for the manual assessment of cardiac rhythm disturbances

Available for Clinical Research

  • Three-lead ECG at 250 Hz and 16 bits, with heart rate, RR intervals, and heart rate variability
  • Dual-band respiratory inductance plethysmography at 125 Hz, with breathing rate, tidal volume, and minute ventilation
  • Three-axis accelerometer at 50 Hz, with activity, steps, cadence, and body position
  • Synchronization through Hexoskin OneApp or Hexoskin OneSync, and study management in Hexoskin OneView

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.

Talk With Our Clinical Team

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.

HMS Signals, Data Channels, and Metrics

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.

Hexoskin Medical System

Shirt and recorder for continuous cardiac, respiratory, and movement recording, with textile sensors and no adhesive electrodes.

HMS Shirt
  • ModelsMen’s and women’s
  • SensorsTextile
ECG Electrodes
  • LeadsThree
  • Sampling250 Hz
  • Resolution16 bits
Respiratory Inductance Plethysmography
  • BandsThoracic and abdominal
  • Sampling125 Hz
Accelerometer
  • AxesThree
  • Sampling50 Hz
  • Resolution0.004 g
Recorder
  • BatteryUp to 72 hours per charge
  • Storage600 hours

FDA-Cleared Output3-lead ECG, heart rate, respiratory rate, and activity, as cleared in K243981Research OutputAvailable in the research configuration

Raw Signals · CardiacFDA-Cleared Output

Three-Lead ECG

250 Hz · 16 bits · 1 µV resolutionContinuous

3 outputs with definitions

  • ECG Lead I (0.0064 mV): Electrocardiogram: Lead I ECG channel with a 16-bit resolution.
  • ECG Lead II (0.0064 mV): Electrocardiogram: Lead II ECG channel with a 16-bit resolution.
  • ECG Lead III (0.0064 mV): Electrocardiogram: Lead III ECG channel with a 16-bit resolution.
Data Channels · CardiacFDA-Cleared Output

Heart Rate

Beats per minute (bpm)Continuous

Heart rate: average over the last 16 heart beats.

Data Channels · CardiacResearch Output

RR Intervals

Seconds (s)Continuous

RR interval: time between two heart beat detections, calculated for every QRS event. Saved at the center of the QRS complex.

Data Channels · CardiacResearch Output

NN Intervals

Seconds (s)Continuous

NN interval: Time between two heart beat detections, calculated for every QRS event.

Data Channels · CardiacResearch Output

Energy Expenditure Estimate

Watts (W)Requires User Profile

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.

Data Channels · CardiacResearch Output

Heart Rate Variability (HRV)

Rolling 5-Minute Window

7 outputs with definitions

  • ANN (average NN interval) (Seconds (s)): Average of the valid RR intervals, calculated over the last 5 minutes.
  • SDNN (Seconds (s)): Standard deviation of the valid RR intervals, calculated over the last 5 minutes.
  • HRV_HF (Milliseconds squared (ms²)): HRV high-frequency power (HF = 0.15 to 0.40 Hz), calculated using the Lomb periodogram.
  • HRV_LF (Milliseconds squared (ms²)): HRV low-frequency power (LF = 0.04 to 0.15 Hz), calculated using the Lomb periodogram.
  • HRV_LF_normalized: HRV LF power normalized: LF / (LF + HF), where LF = 0.04 to 0.15 Hz and HF = 0.15 to 0.40 Hz.
  • HRV_triangular: HRV triangular index, calculated over the last 5 minutes.
  • NN_over_RR (NN/RR ratio): Ratio of valid NN intervals to all RR intervals over the last 5 minutes. Use as a quality score for the HRV results.
Signal Quality · CardiacResearch Output

Heart Rate Quality

Continuous

Heart rate status: quality of the heart rate signal.

Signal Quality · CardiacResearch Output

QRS Detection Quality

Continuous

QRS status: status of the last QRS detection.

Metrics · CardiacResearch Output

Heart Rate

Any Range or RecordMax Sprint Test5-Minute Rest Test

6 outputs with definitions

  • HR Avg (Beats per minute (bpm)): Average value of the heart rate (HR) for that range (activity) or record. Any Range or Record
  • HR Min (Beats per minute (bpm)): Minimum value of the heart rate (HR) for that range (activity) or record. Any Range or Record
  • HR Max (Beats per minute (bpm)): This metric does double duty depending on the context. On a range (activity) or record, it represents the maximum value of the heart rate (HR) for a given period. In a profile it represents the user's overall maximum heart rate. Any Range or RecordMax Sprint Test
  • HR Histogram (Beats per minute (bpm)): Histogram of the heart rate (HR) over time. Any Range or Record
  • Resting Heart Rate (Beats per minute (bpm)): Lowest heart rate value that is measured sitting down, when fully relaxed, without any distractions. Can be measured by completing the fitness test “5 minutes Rest Test” on Hexoskin OneApp. Otherwise, the default value will be attributed according to the user’s profile information (i.e. gender, age, etc.) 5-Minute Rest Test
  • Heart Rate Recovery (Beats per minute (bpm)): Reduction of heart rate (HR) after a fixed duration of recovery (1 minute) following a peak-intensity exercise. Max Sprint Test
Metrics · CardiacResearch Output

Heart Rate Variability (HRV)

5-Minute Rest TestAny Range or RecordDuring Sleep

13 outputs with definitions

  • RMSSD (Milliseconds (ms)): Root mean square of the successive differences. Time-domain measure reflecting the beat-to-beat variance in heart rate. 5-Minute Rest Test
  • AVNN (Seconds (s)): Average of the N-N intervals. Any Range or Record
  • SDNN (Seconds (s)): Standard deviation of all of the N-N intervals. Any Range or Record
  • ASDNN (Seconds (s)): Average of the standard deviations of all N-N intervals. Any Range or Record
  • SDANN (Seconds (s)): Standard deviation of the averages of the N-N intervals. Any Range or Record
  • Power NN (Milliseconds squared (ms²)): Total power, or variance, of the N-N intervals. Any Range or Record
  • Triangular Index: Integral of the density distribution (the number of all the N-N intervals) divided by the maximum of the density distribution. Any Range or Record
  • HRV (HF) (Percent (%)): Average value of HRV high-frequency power normalized. During Sleep
  • HRVHF Avg (Milliseconds squared (ms²)): Average value of HRV high-frequency power. During Sleep
  • HRVHF Norm Max (Percent (%)): Maximum value of HRV high-frequency power normalized. During Sleep
  • HRVHF Norm Min (Percent (%)): Minimum value of HRV high-frequency power normalized. During Sleep
  • HRVLF Avg (Milliseconds squared (ms²)): Average value of HRV low-frequency power. During Sleep
  • HRVLF Norm Avg (Percent (%)): Average value of HRV low-frequency power normalized. During Sleep
Metrics · CardiacResearch Output

Energy Expenditure

Requires User Profile

6 outputs with definitions

  • Energy (Kilocalories (kcal)): Total energy based on user-specific VO2, using the Mifflin and Keytel equation. VO2max, HRmax and HRmin are defined per user by the fitness tests; if the tests were not completed, defaults based on age and sex are used.
  • Energy Avg (Watts (W)): Average value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
  • Energy Min (Watts (W)): Minimum value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
  • Energy Max (Watts (W)): Maximum value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
  • Energy Histogram (Watts (W)): Histogram value of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin are defined for each user.
  • Energy Total (Joules (J)): Total of energy based on userSpec VO2. We used the Mifflin and Keytel equation where the VO2max, HRMax, HRMin is defined for each user.
Raw Signals · RespiratoryResearch Output

Thoracic and Abdominal Respiration

Two breathing bands (RIP) · 125 HzContinuous

2 outputs with definitions

  • Thoracic RIP signal: Respiratory inductance plethysmography, thoracic band, sampled at 125 Hz with a 16-bit resolution.
  • Abdominal RIP signal: Respiratory inductance plethysmography, abdominal band, sampled at 125 Hz with a 16-bit resolution.
Data Channels · RespiratoryFDA-Cleared Output

Breathing Rate

Respirations per minute (rpm)Continuous

Breathing rate: calculated over the last 7 respiration cycles.

Data Channels · RespiratoryResearch Output

Inspiration Events

Continuous

Inspiration: detection of an inspiration onset event.

Data Channels · RespiratoryResearch Output

Expiration Events

Continuous

Expiration: detection of an expiration onset event.

Data Channels · RespiratoryResearch Output

Minute Ventilation

Milliliters per minute (mL/min)Continuous

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.

Data Channels · RespiratoryResearch Output

Minute Ventilation, Adjusted

Milliliters per minute (mL/min)Requires User Profile

Minute Ventilation, Adjusted: Volume of air per minute inspired in the last 7 complete respiration cycles, adjusted for the user profile.

Data Channels · RespiratoryResearch Output

Tidal Volume

Milliliters (mL)Continuous

Tidal Volume: Volume of air inspired in the last inspiration. Based on the raw signal; for study reporting use tidal_volume_adjusted.

Data Channels · RespiratoryResearch Output

Tidal Volume, Adjusted

Milliliters (mL)Requires User Profile

Tidal Volume, Adjusted: Volume of air inspired in the last inspiration, adjusted for the user profile.

Signal Quality · RespiratoryResearch Output

Breathing Rate Quality

Continuous

Breathing rate status: quality of the breathing rate signal.

Metrics · RespiratoryResearch Output

Breathing Rate

Any Range or Record

5 outputs with definitions

  • BR Avg (Respirations per minute (rpm)): Average value of the breathing rate (BR) for that range (activity) or record.
  • BR Min (Respirations per minute (rpm)): Minimum value of the breathing rate (BR) for that range (activity) or record.
  • BR Max (Respirations per minute (rpm)): Maximum value of the breathing rate (BR) for that range (activity) or record.
  • BR Histogram (Respirations per minute (rpm)): Histogram of the breathing rate (BR) over time.
  • BRV (Milliseconds (ms)): Time-domain measure used to assess breathing rate variability (BRV).
Metrics · RespiratoryResearch Output

Minute Ventilation

Any Range or RecordRequires User Profile

8 outputs with definitions

  • MV Avg (Liters per minute (L/min)): Average value of the minute ventilation. Based on the raw signal; for study reporting use MV Adjusted Avg. Any Range or Record
  • MV Min (Liters per minute (L/min)): Minimum value of the minute ventilation. Based on the raw signal; for study reporting use MV Adjusted Min. Any Range or Record
  • MV Max (Liters per minute (L/min)): Maximum value of the minute ventilation. Based on the raw signal; for study reporting use MV Adjusted Max. Any Range or Record
  • MV Histogram (Liters per minute (L/min)): Histogram of the minute ventilation. Based on the raw signal; for study reporting use MV Adjusted Histogram. Any Range or Record
  • MV Adjusted Avg (Liters per minute (L/min)): Average value of the adjusted minute ventilation, calculated from the weight of the user and the Hexoskin RIP band adjustment factor. Requires User Profile
  • MV Adjusted Min (Liters per minute (L/min)): Minimum value of the adjusted minute ventilation. Requires User Profile
  • MV Adjusted Max (Liters per minute (L/min)): Maximum value of the adjusted minute ventilation. Requires User Profile
  • MV Adjusted Histogram (Liters per minute (L/min)): Histogram of the adjusted minute ventilation over time. Requires User Profile
Metrics · RespiratoryResearch Output

Tidal Volume

Any Range or RecordRequires User Profile

8 outputs with definitions

  • Tidal Volume Avg (Liters (L)): Average value of the tidal volume. Based on the raw signal; for study reporting use Tidal Volume Adjusted Avg. Any Range or Record
  • Tidal Volume Min (Liters (L)): Minimum value of the tidal volume. Based on the raw signal; for study reporting use Tidal Volume Adjusted Min. Any Range or Record
  • Tidal Volume Max (Liters (L)): Maximum value of the tidal volume. Based on the raw signal; for study reporting use Tidal Volume Adjusted Max. Any Range or Record
  • Tidal Volume Histogram (Liters (L)): Histogram of the tidal volume. Based on the raw signal; for study reporting use Tidal Volume Adjusted Histogram. Any Range or Record
  • Tidal Volume Adjusted Avg (Liters (L)): Average value of the adjusted tidal volume. Requires User Profile
  • Tidal Volume Adjusted Min (Liters (L)): Minimum value of the adjusted tidal volume. Requires User Profile
  • Tidal Volume Adjusted Max (Liters (L)): Maximum value of the adjusted tidal volume. Requires User Profile
  • Tidal Volume Adjusted Histogram (Liters (L)): Histogram of the adjusted tidal volume over time. Requires User Profile
Metrics · RespiratoryResearch Output

Respiration Coefficient

Requires User Profile

Respiration Coefficient: Calculated from the adjusted minute ventilation and the adjusted tidal volume. Reflects the O2 input and CO2 output of the user.

Metrics · RespiratoryResearch Output

Volume Expired

Liters (L)Expired-Volume Test

Volume Expired: Maximum expired volume, standard test.

Raw Signals · Activity and MovementResearch Output

Three-Axis Acceleration

50 Hz · 0.004 g resolutionGravitational acceleration (g)Continuous

Acceleration: three-axis sensor with a 0.004 g resolution.

Data Channels · Activity and MovementFDA-Cleared Output

Activity

Gravitational acceleration (g)Continuous

Activity: signal based on the accelerometer intensity vector.

Data Channels · Activity and MovementResearch Output

Cadence

Steps per minute (spm)Continuous

Cadence: averaged over the last 7 strides, based on the accelerometer.

Data Channels · Activity and MovementResearch Output

Steps

StepsContinuous

Step: the number of steps since the beginning of a recording.

Data Channels · Activity and MovementResearch Output

Device Position

Continuous

Device position: gives the onset of a position change.

Metrics · Activity and MovementResearch Output

Activity Intensity

Any Range or Record

4 outputs with definitions

  • Act Avg (Gravitational acceleration (g)): Average value of the activity signal for that range (activity) or record.
  • Act Min (Gravitational acceleration (g)): Minimum value of the activity signal for that range (activity) or record.
  • Act Max (Gravitational acceleration (g)): Maximum value of the activity signal for that range (activity) or record.
  • Act Histogram (Gravitational acceleration (g)): Histogram of the acceleration signal measured by the three-axis accelerometer over time.
Metrics · Activity and MovementResearch Output

Cadence

Any Range or Record

4 outputs with definitions

  • Cadence Avg (Steps per minute (spm)): Average value of the cadence for that range (activity) or record.
  • Cadence Min (Steps per minute (spm)): Minimum value of the cadence for that range (activity) or record.
  • Cadence Max (Steps per minute (spm)): Maximum value of the cadence for that range (activity) or record.
  • Cadence Histogram (Steps per minute (spm)): Histogram of the cadence for that range (activity) or record.
Metrics · Activity and MovementResearch Output

Steps

StepsAny Range or Record

Steps: Number of steps detected for that range (activity) or record.

Data Channels · SleepResearch Output

Sleep Phase

During Sleep

Sleep phase: gives the onset of a sleep phase change.

Data Channels · SleepResearch Output

Sleep Position

During Sleep

Sleeper position: gives the onset of a position change.

Metrics · SleepResearch Output

Sleep Architecture

During Sleep

8 outputs with definitions

  • Total Sleep Time (Seconds (s)): Time spent in any sleep phase, that is, not awake.
  • Sleep REM Time (Seconds (s)): Total time in the REM sleep phase during the sleep period, defined as the time between sleep onset and the last awakening.
  • Sleep Non REM Time (Seconds (s)): Total time in the NREM sleep phase during the sleep period, defined as the time between sleep onset and the last awakening.
  • Sleep Wake Time (Seconds (s)): Total time in the awake vigilance state during the sleep period, defined as the time between sleep onset and the last awakening.
  • Time to Fall Asleep (sleep latency) (Seconds (s)): Time between the sleep activity onset and the first sleep phase detection.
  • Sleep Efficiency (Percent (%)): Proportion of time asleep over the time in bed. Normally above 95 percent; a value under 85 percent is generally associated with a poor night.
  • Sleep Percent (Percent (%)): Proportion of time asleep over the sleep time, where sleep time equals time in bed minus sleep latency.
  • Sleep Phase Histogram: Histogram of the sleep phases.
Metrics · SleepResearch Output

Sleep Position

During Sleep

7 outputs with definitions

  • Sleep Position Changes (Repetitions (rep)): Number of sleep position changes detected for that night.
  • Sleep Position Histogram: Histogram of the sleep position changes.
  • Sleep Position P1 Time (Seconds (s)): Total time in sleep position 1, which corresponds to belly if the device is in orientation 2.
  • Sleep Position P2 Time (Seconds (s)): Total time in sleep position 2, which corresponds to back if the device is in orientation 2.
  • Sleep Position P3 Time (Seconds (s)): Total time in sleep position 3, which corresponds to right if the device is in orientation 2.
  • Sleep Position P4 Time (Seconds (s)): Total time in sleep position 4, which corresponds to left if the device is in orientation 2.
  • Sleep Position P5 Time (Seconds (s)): Total time in sleep position 5, which corresponds to standing or sitting if the device is in orientation 2.
Metrics · Session and FitnessResearch Output

Duration

Seconds (s)Any Range or Record

Duration: Total duration of the range (activity or time range) or record.

Metrics · Session and FitnessResearch Output

Recorded Time

Seconds (s)Any 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.

Metrics · Session and FitnessResearch Output

VO2 max

Milliliters per kilogram per minute (mL/kg/min)12-Minute Run Fitness Test

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.

Research and Evidence

Published studies show how teams recorded sleep at home and compared it with reference assessments.

Research Overview

Wearable Monitoring for Clinical Development

Hexoskin overview of wearable physiological recording in clinical development studies.

Read the Source

Scientific Publications

Research library. The Hexoskin and Astroskin publication library, searchable by research area and measurement.

Read the Source

White Papers

Background reading on continuous physiological monitoring in this field. Each paper is a free download.

Cover of the white paper Overcoming Data Loss in Clinical Trials with Hexoskin

White Paper · 2021 · 4 pages

Overcoming Data Loss in Clinical Trials with Hexoskin

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
Cover of the white paper Continuous Respiratory Monitoring with Hexoskin

White Paper · 2021 · 9 pages

Continuous Respiratory Monitoring with Hexoskin

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
Cover of the white paper A Comparative Perspective on Wearables for Advanced Respiratory Monitoring

White Paper · 2021 · 15 pages

A Comparative Perspective on Wearables for Advanced Respiratory Monitoring

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 Paper

Discuss Sleep Measures for Your Protocol

Tell us the indication, the population, and the nights the protocol needs. A clinical specialist will reply with the next step.