Somno-ART The Innovative Wearable Medical Device For Objective Sleep Measurements User Manual
- June 4, 2024
- Somno-ART
Table of Contents
Somno-ART The Innovative Wearable Medical Device For Objective Sleep
Measurements
Introduction
Medical Indications
Sono-Art Software is standalone software, which analyses physiological signals
of heart rate and movements of adults in order to assess the subject’s sleep
parameters, including sleep continuity, latencies, and architecture. Somno-Art
Software results are intended to be used for sleep structure characterization
and as an aid for diagnosis and treatment follow-up of sleep disturbances and
disorders by a healthcare professional. Analyzed sleep periods must be periods
of sleep allocated time lasting at least 5 hours, starting when the subject is
still awake and recorded in a non-moving sleep environment. Signals of heart
rate and movements must be synchronized together, the heart rate must have a
beat-to-beat resolution, and movements a 1-sec resolution.
Patient Population
Somno-Art Software is intended to be used on adults only. Sleep recordings
from patients suffering from heart rate disorders cannot be analyzed with
Somno-Art Software. Somno-Art Software is not intended for subjects wearing
cardiac devices (i.e. defibrillator, stimulator…), under a beta-receptor
blocking agent treatment, or with active cardiovascular disease (including but
not limited to: atrial fibrillation or flutter, second and third-degree
atrioventricular heart block, resting supraventricular tachycardia > 100 beats
per minute, unstable ischemic heart disease, valvular abnormality, sick sinus
syndrome or other condition requiring pacemaker) or diastolic blood pressure >
110 mmHg.
Pathological motor activity cannot be considered in the use of the Somno-Art
Software analysis and have to be considered as an exclusion criterion.
Intended User
Somno-Art Software is intended for use by trained professionals only. Patients
and healthcare professionals do not have access to Somno-Art Software. Results
are used by healthcare professionals with sleep expertise.
Manufacturer
- PPRS
- 4E Avenue du Général de Gaulle
- 68000 Colmar
- FRANCE
- +33 (0)3 89 20 19 51
- support@somno-art.com
- www.somno-art.com
Lifetime of the device
The last version of this software will be supported by PPRS for 3 years after
its release date.
Input Data
The software reads night recordings of beat-to-beat cardiac intervals and movements stored in Somno-Art Recording (SAR) or Extensible Markup Language (XML) file formats. Somno-Art Software performances have been established for a time in bed lasting more than 5 hours. In order to be analyzable by the software, the period between Lights Off and Lights On events described in recordings must be strictly superior to 5 minutes. This input data must be transferred to Somno-Art Trained Professionals in a secure manner for being analyzed by Somno-Art Software.
Somno-Art Recording (SAR)
The software reads night recordings stored in SAR files (Somno-Art Recording),
produced by the Somno-Art Device. These files noticeably contain:
- Actimetry signals and beat-to-beat cardiac intervals
- Lights Off, Lights On and event times
- Information about the subject SAR files are supported since version “V1.1.1[1.7.0]” of the Somno-Art Device.
Extensible Markup Language (XML)
The software also reads night recordings stored in XML files respecting a
specific schema. These files contain among others:
- Actimetry signal and beat-to-beat cardiac intervals
- Lights Off, Lights On and event times
- Information about the subject
Lights Off and On events indicate from which point in the recording the software will start its sleep analysis and at which point it will stop.
All formats
All input files must respect the following naming convention: <recording
identifier>.
Data quality review
The signals of the recording will be reviewed according to specific criteria
by the Somno-Art Trained Professional, which will allow determining their
quality. Recordings with major issues, which make analysis impossible, will be
excluded from the analysis.
Outputs
The produced outputs are of two types:
- Recording-related output: Covers one particular recording analysis
- Global output: Describes several recordings analyzed. Outputs can be CE-marking or FDA-marking compliant. As only one type of output is produced, the outputs type has to be decided with PPRS at the beginning of the study.
Recording Related outputs
For each night recording analyzed, a sleep stage classification is
automatically performed by the software. Sleep parameters are then computed
based on classification, alongside some other metrics. This generated
information is exported in both exploitable file formats (text files,
Microsoft Excel) and rendered file format (pdf).
Sleep stage classification
Sleep stage classifications are exported in a text file format, which gives
the determined sleep stage for each 30-second page of the record. The 1-s
epoch classification is down-sampled into 30-s epochs. To do so, the dominant
stage (or the first occurring stage, if they were equally represented) is
selected. 
Filename: Somno-Art__HYPNO.txt
Note: if outputs are CE-marking compliant, the classification is a 4-stages classification (W, N1+N2, N3, REM). If outputs are FDA-marking compliant, it is a 3 stages classification (W, NREM, REM).
Sleep report
A sleep report for each recording analyzed is generated. This report can be
classic or simplified (for CE outputs), depending on healthcare professionals’
needs. As only one type of report is produced, the report type has to be
decided with PPRS at the beginning of the study. Classic sleep report
CE outputs
This document includes general information about the recording, an image of
the determined hypnogram, the computed sleep architecture parameters besides
their normative values, the matrix of sleep stages transitions, some measures
performed on the recording and a guide about how to read the report. This
report is in PDF file format.
FDA outputs
This document includes general information about the recording, an image of
the determined hypnogram, the computed sleep architecture parameters and a
guide about how to read the report. This report is in PDF file format.
Figure 2: Client Report output (extract)
Filename PDF: Somno-Art_.pdf If the recording device runs out
of battery, a message is added to inform the user:
Figure 3 : Warning message in case of device out of battery
When Somno-Art Software is not able to analyze the whole recording, it gives a
partial analysis and informs the user with the following warning message:
Figure 4: Warning message in case of partial analysis
If the signal quality is poor at Lights Off, the Lights Off is shifted (of
maximum one minute) and a warning message informs the user:
Figure 5: Warning in cas of shifted Lights Off
Finally, a warning message appears if the filename does not correspond to
study, subject, record and/or visit information stored in the file.
Figure 6: Warning in case of filename issue Simplified report (CE outputs
only)
This document includes general information about the recording, an image of
the determined hypnogram, the computed sleep architecture parameters besides
their normative values, some measures performed on the recording and a guide
on how to read the report. This report is in PDF file format.
Signals exported in CSV format
CSV files with the content of SAR input files can be generated. These 3 files
contain the following information:
- Somno-Art__header+Events.CSV: information from SAR file header and events from SAR file
- omno-Art__MV.csv : actimetry from SAR file accumulated every 30 seconds
- Somno-Art__RR.csv : raw RR intervals from SAR file
Global analysis-related outputs
These outputs aggregate the results of several recordings.
Sleep parameters
These documents aggregate the sleep architecture parameters of all recordings
and store them in two Microsoft Excel tables: one for standard sleep
parameters and the other one for remaining parameters (CE outputs only
).
- Filename standard parameters: Somno-Art_SLEEP_PARAMS.xlsx
- Filename Extra Parameters: Somno-Art_EXTRA_PARAMS.xlsx
In both files, a tab “Definitions” contains the definition of all sleep parameters given in the Excel table. A tab “Info” contains information about the date of the analysis and the software version.
CE outputs
The file Somno-Art_SLEEP_PARAMS.xlsx contains the following sleep parameters:
- Lights Off Time: Lights off clock time (hr:min: sec). First epoch (included) of sleep analysis
- Lights On Time: Lights on clock time (hr:min: sec). Last epoch (excluded) of sleep analysis
- Sleep Alloc. Time (min.): Sleep allocated time. Duration from Lights Off to Lights On
- Total sleep Time (min.) (TST): Total duration of non-W stages
- Sleep Latency (min.): Or sleep onset. Time from Lights Off to any sleep stage
- WASO (min.): Wake after Sleep Onset, duration of W stages after sleep onset
- Sleep Eff. (%): Sleep efficiency. Total sleep time over sleep allocated time
- Latency R (min.): Time from Sleep Onset to first REM
- W Dur. (min.): Total duration of W, from Lights Off to Lights On
- N1+N2 Dur. (min.): Total duration of N1+N2, from Lights Off to Lights On
- N3 Dur. (min.): Total duration of N3, from Lights Off to Lights On
- R Dur. (min.): Total duration of REM, from Lights Off to Lights On
- N1+N2 Perc. (%): N1+N2 percentage. Total N1+N2 duration over total sleep time
- N3 Perc. (%): N3 percentage. Total N3 duration over total sleep time
- R Perc. (%): REM percentage. Total REM duration over total sleep time
- The file Somno-Art_EXTRA_PARAMS.xlsx contains the following sleep parameters and metrics:
- NREM Dur. (min.): Total duration of N1, N2, and N3, from Lights Off to Lights On
- NREM Perc. (%) : NREM Sleep percentage. NREM Sleep duration over total sleep time
- WASO Perc. (%): WASO percentage. Duration of W stages after sleep onset over the duration from Sleep Onset to Lights On
- Sleep Latency N1+N2 (min.): Time from Lights Off to first N1 or N2 stage
- Sleep Latency N3 (min.) : Time from Lights Off to first N3
- Sleep Latency R (min.): Time from Lights Off to first REM
- Latency N1+N2 (min.): Time from Sleep Onset to first N1 or N2 stage
- Latency N3 (min.): Time from Sleep Onset to first N3
- LPS (min.): Latency to persistent sleep. Time from Lights Off to the first occurrence of continuous 10 min in any sleep stage
- WALPS (min.): Wake after latency to persistent sleep
- P R Onset (min.): Persistent REM Onset. Time from Lights Off to the first occurrence of continuous 2 min in REM
- P R Latency (min.): Persistent REM Latency. Time from Sleep Onset to the first occurrence of continuous 2 min in REM
- Latency LPS -> R (min.): Time from Latency to persistent sleep to first REM
- No. of stage changes: Number of sleep stage changes
- No. of ascending stage changes: Number of sleep stage changes to a lighter sleep stage or to wake
- No. of descending stage changes: Number of sleep stage changes to a deeper sleep stage
- No. of Awk.: Number of Awakenings, from sleep onset to Lights On. If the last stage is W, it doesn’t count
- No. of Awk. >15s: Number of Awakenings exceeding 15 seconds, from sleep onset to Lights On. If the last stage is W, it doesn’t count.
- WASF (min.): Wake time after sleep offset. Total duration of W from last sleep stage to Lights On.
- No. of Cycles: Number of sleep cycles
- No. of Mov.: Number of individualized movements
- No. of Mov. before SO: Number of individualized movements before Sleep Onset
- No. of Mov. after SO: Number of individualized movements after Sleep Onset
- No. of Mov. before PSO: Number of individualized movements before Persistent Sleep Onset
- No. of Mov. after PSO: Number of individualized movements after Persistent Sleep Onset
- Mov. dur. (min): Movements total duration
- Mov dur before SO (min.): Movements duration before Sleep Onset
- Mov dur after SO (min.): Movements duration after Sleep Onset
- Mov dur before PSO (min.): Movements duration before Persistent Sleep Onset
- Mov dur after PSO (min.): Movements duration after Persistent Sleep Onset
- No. of AC: Number of Cardiac Arousals
- No. of AC before SO: Number of Cardiac Arousals before Sleep Onset
- No. of AC after SO: Number of Cardiac Arousals after Sleep Onset
- No. of AC before PSO: Number of Cardiac Arousals before Persistent Sleep Onset
- No. of AC after PSO: Number of Cardiac Arousals after Persistent Sleep Onset
- AC dur. (min): Cardiac Arousals total duration
- AC dur. before SO (min.): Cardiac Arousals total duration before Sleep Onset
- AC dur. after SO (min.): Cardiac Arousals total duration after Sleep Onset
- C ampl. (bpm): Average amplitude of Cardiac Arousals
- AC ampl. before SO (bpm): Average amplitude of Cardiac Arousals before Sleep Onset
- AC ampl. after SO (bpm): Average amplitude of Cardiac Arousals after Sleep Onset
DA outputs
The file Somno-Art_SLEEP_PARAMS.xlsx contains following sleep parameters:
- Lights Off Time: Lights off clock time (hr:min:sec). First epoch (included) of sleep analysis
- Lights On Time: Lights on clock time (hr:min:sec). Last epoch (excluded) of sleep analysis
- Sleep Alloc. Time (min.): Sleep allocated time. Duration from Lights Off to Lights On
- Total sleep Time (min.) (TST): Total duration of non-W stages
- Sleep Latency (min.): Or sleep onset. Time from Lights Off to any sleep stage
- WASO (min.): Wake after Sleep Onset, duration of W stages after sleep onset
- Sleep Eff. (%): Sleep efficiency. Total sleep time over sleep allocated time
- LPS (min.): Latency to persistent sleep. Time from Lights Off to the first occurrence of continuous 10 min in any sleep stage
- W Dur. (min.): Total duration of W, from Lights Off to Lights On
- N1+N2 Dur. (min.): Total duration of N1+N2, from Lights Off to Lights On
- Non-REM Dur. (min.): Total duration of Non-REM Sleep, from Lights Off to Lights On
- R Dur. (min.): Total duration of REM, from Lights Off to Lights On
Both types
The analysis status is reminded for each recording. For some statuses, the
results provided are only informative or only calculated on a portion of the
night.
The main analysis status can be:
- “Done”: the analysis was performed successfully.
- “Warning”: the analysis was performed but a warning was raised, specified by secondary status. A secondary status can be added to the main status to specify the warning. The different cases are:
- “out of battery”: the recording ends before given Lights On (due to a critical battery level).
- “partial”: the analysis was stopped before Lights On, because of major invalidity in input signals. The results are given on the analyzed period (between Lights Off and analysis stop) only.
- “Lights Off shifted”: the Lights Off was moved (of maximum one minute) because of poor signal quality at this time.
- “filename issue”: the filename does not correspond to study, subject, record, and/or visit information stored in the file
References
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- Somno-Art - The innovative wearable medical device for objective sleep measurements