In-Home, Patient Applied Objective Assessment of Sleep Architecture & Continuity

Sleep Profiler™ EEG Sleep Monitor bridges the gap between laboratory polysomnography and actigraphy. Three frontopolar channels provide the EEG, EOG and EMG signal features needed to characterize by-stage sleep time. The lightweight, wireless device includes voice messages and other intuitive design features that enable reliable self-application in the home with acquisition across multiple nights.

Sleep Profiler combines web-based presentation of recorded signals with validated auto-staging and technical editing capabilities. Interpretation features include customized editing, touch-point insertion of key diagnostic and treatment recommendations, and secure signature insertion.

Report formats include automated generation of medical history summaries, medication usage, comparison to age/sex normative ranges, and patient reports that contrast their sleep diary entries to the objective sleep quality measures.

Sleep Profiler RTA combines wireless transmission of the signals to a tablet with real-time sleep staging for the monitoring of sleep quality and abnormal EEG patterns in hospitalized patients or in research applications.

Features

  • Records EEG, EOG, EMG, with optional submental EMG or ECG, pulse rate, head position, head movement, quantitative snoring
  • Auto-staging accuracy equivalent to PSG-based manual staging variability with:
  • sleep spindles, spindle duration and power spectral densities
  • movement arousals, cortical arousals, microarousals and autonomic activations
  • sleep latency, REM latency, N3 latency
Auto-Staging Validated to PSG
  • Monitors study status and automatically sends reminder emails
  • Multi-night studies with night-to-night comparisons
  • Up to 30 hours of in-home recording between battery charges
  • Objective vs. subjective comparison report
  • Continuous 24/7 monitoring available for the ICU or Hospital
  • Available with application of novel sleep biomarkers

Applications

Clinical
  • Sleep Profiler enables clinicians to easily and accurately:
  • Differentiate short sleep syndrome from sleep state misperception
  • Identify abnormal sleep patterns attributed to chronic or neurodegenerative diseases
  • Monitor the effects of OSA therapy on sleep quality
  • Assess the dose-dependent medication effects on sleep architecture and sleep continuity
  • Sleep Profiler is ideal for multi-night or repeated measures assessment of patients complaining of symptoms consistent with:
  • Insomnia
  • Hypersomnia
  • Other non-OSA sleep disorders
Research
  • Sleep Profiler is being used by researchers to assess:
  • REM sleep without Atonia in patients with RBD
  • Prodromal sleep biomarkers for neurodegenerative disease
  • Effect of Suvorexant progressive supranuclear palsy
  • Differences between normal cognition and mild cognitive impairment, Alzheimer’s disease, Parkinson’s Dementia, and Dementia with Lewy Body
  • Sleep patterns in patients with ICU delirium
  • Effects of medication type, timing, and dosage on ICU sleep and outcomes
  • Sleep quality changes as a result of cannabis and opioid dependency
  • Outcomes resulting from an insomnia intervention
  • Influence of sleep deprivation on memory

Clinical Evidence

Proof-of-concept for characterization of neurodegenerative disorders using two non-REM biomarkers. Levendowski DJ, Neylan TC, Walsh CM, et al. Front Neurol. 2023; 14: DOI fneur.2023.1272369.
Keyword:  Sleep EEG, neurodegenerative disorder biomarker
Non-REM sleep with hypertonia in Parkinsonian Spectrum Disorders: A pilot Investigation. Levendowski DJ, Walsh CM, Boeve BF, et al. Sleep Med, 2022: 100:501-510.
Keyword: Sleep EEG, neurodegeneation, biomarkers
Autonomic dysregulation during sleep in Parkinsonian Spectrum disorders – a proof-of-concept. Cho Y, Levendowski DJ, Walsh CM, et al. Parkinsonism Relat Disord. 2023; j.parkreldis.2023.105905.
Keyword: Sleep EEG, neurodegenerative disorder biomarker
The accuracy and reliability of sleep staging and sleep biomarkers in patients with isolated rapid eye movement sleep behavior disorder. Levendowski DJ, Neylan, TC, Lee-Iannotti J, et al. Nat Sci Sleep, 2023:
Keyword: Neurodegeneation
The accuracy, night-to-night variability, and stability of frontopolar sleep EEG biomarkers. Levendowski DJ, Ferini-Strambi L, Gamaldo C, et al. J Clin Sleep Med, 2017; 13(6):791-803.  
Keyword: Sleep EEG validation, insomnia, medication  
The need for a reliable Sleep EEG biomarker.  Penzel T, Fietze I,Veauthier C.  JCSM 2017; 13(6):771-772.
Keyword: Sleep EEG biomarkers
Portable sleep monitoring systems: Broadening the horizons.  Covassin N, Somers VK.  J Clin Sleep Med 2017; 13(6):773:774.  
Keyword: Sleep EEG and medication
Sleep and sleep position: potential implications for patients with neurodegenerative disease.  Levendowski DJ, Gamaldo C, St. Louis E, etal. J Alzheimers Dis  2019;67(2):631-638.  
Keyword: Sleep EEG and neurodegenerative disease
Reduced non-rapid eye movement sleep is associated with tau pathology in early Alzheimer's disease.  Lucey B, McCullough A, Landsness EC, etal.  Sci Transl Med 2019; 11:(474):DOI 10.1126/scitranslmed.aau6550  
Keyword: Sleep EEG and neurodegenerative disease
Multi-modal home sleep monitoring in older adults.  Toedebusch CD. McLeland JS, Schaibley CM et al.  J Vis Exp 2019;26(143) DOI 10.3791/58823  
Keyword: Sleep EEG and neurodegenerative disease
Comparison of EMG power during sleep from the submental and frontalis muscles.  Levendowski DJ, St. Louis, E, Ferini-Strambi L, et al. Nat Sci Sleep 2018; 10:431-437.  
Keyword: Sleep EEG and neurodegenerative disease
Effects of deep sedation on sleep in critically ill medical patients on mechanical ventilation.  Jean R, Shah, P, Yudelevich E, et al.  J Sleep Res 2019, DOI10.111/jsr.12894.
Keyword: Sleep EEG and neurodegenerative disease
Processed EEG monitoring for anesthesia and intensive care practice.  Fomagnoli S, Franchi F, Ricci Z.  Minerva Anesthesiol 2019: 85(11):1219-1230.  
Keyword: Sleep and ICU
Sleep duration and architecture innon-intubated Intensive Care Unit patients:  An observational study.  Romagnoli S, Villa G, Fontanarosa L, et al.  SleepMed 2020, DOI10.1016/j.sleep.11.1265.  
Keyword: Sleep and ICU
Multimodal assessment of sleep in men and women during treatment for opioid use disorder. Finan PH, Mun CJ, Epstein DH et al. Drug Alcohol Dependence 2020;207: 1-7.  
Keyword: Sleep EEG and medication
The effect of sleep deprivation on emotional memory consolidation in participants reporting depressive symptoms. Harrington MO, Nedberge KM, Durrant SJ.  Neurobiol Learning Memory 2018; 152:10-19.
Keyword: Sleep EEG and memory
Comparison of a single-channel EEG sleep study to polysomnography. Lucey B, McLeland JS,Toedebusch CD et al. J Sleep Res, 2016;25(6):625-635.  
Keyword: Sleep EEG validation
Validation of a wireless, self-application, ambulatory electroencephalographic sleep monitoring device in healthy volunteers.  Finan PH, RichardsJM, Gamaldo CE, et al. J Clin Sleep Med,  2016;12(1):443-1451.  
Keyword: Sleep EEG validation
Scoring accuracy of automated sleep staging from a bipolar electroocular recording compared to manual scoring by multiple raters. Stepnowsky C, Levendowski D, Popovic D, etal.  SleepMed,  2013;14(11):1199-077.
Keyword: Sleep EEG validation
Retrospective cross-validation of automated sleep staging using electroocular recordings inpatients with and without sleep disordered breathing.  Levendowski DJ, Popovic D, Berka C, et al.  IntArch Med, 2012;5(1):21.              
Keyword: Sleep EEG validation
Automatic scoring of sleep stages and cortical arousals using two electrodes on the head:  validation in healthy adults. Popovic D, Khoo M, Westbrook P. J Sleep Res, 2014:23(2):211-21.
Keyword: Sleep EEG validation
A systematic comparison of factors that could impact treatment recommendations for patients with Positional Obstructive Sleep Apnea (POSA). Levendowski DJ, Oksenberg A, Vicini C et al.  SleepMed 2018; 50:145-151.  
Keyword: Unattended PSG, positional OSA
A comparison between auto-scored apnea-hypopnea index and oxygen desaturation index in the characterization of positional obstructive sleep apnea.  Levendowski DJ, Hamilton GS, St. Louis EK, etal.  NatSci Sleep 2019; 11;69-78.  
Keyword: Unattended PSG
Sleep Biomarker phenotyping of neurodegenerative disorders using artificial intelligence. Levendowski DJ, Tsuang D, Neylan T, et al. Sleep Advances. 2023; 4:DOI sleepadvances/zpad035.107.
Keyword: Neurodegeneration, supine sleep
Atypical N3 sleep: A biomarker for altered mental status in Lewy body disease? Levendowski DJ, Lee-Iannotti JK, Tsuang D, et al. Sleep Advances. 2023; 4:DOI sleepadvances/zpad035.110.
Keyword: Neurodegenerative disorder phenotyping
Head position during sleep: Potential implications for patients with neurodegenerative disorders. Levendowski DJ, Walsh C, Neylan T, et al. Sleep Advances. 2023; 4:DOI sleepadvances/zpad035.097.
Keyword: Neurodegeneration, supine sleep
Comparison of sleep and wake EEG biomarkers in mild cognitive impairment and Alzheimer’s disease dementia. Meghdadi AH, Levendowski DJ, Kovacevic N et al. Meeting of the AAIC, Amsterdam, Netherlands. 2023
Keyword: EEG and Neurodegeneration
Potential role of physicians in addressing the needs of those at-risk of a neurodegenerative disorder – A pilot study. Levendowski DJ, Berka C, Neylan TC, et al. Sleep 2023. Indianapolis, IN.
Keyword: Neurodegeneration
A community-based survey of personal perspectives regarding prodromal sleep screening for neurodegenerative disorders. Levendowski DJ, Berka C, Neylan TC, et al. Sleep 2023. Indianapolis, IN.
Keyword: Neurodegeneration
Characterization of neurodegenerative disorder subtypes based on Non-REM hypertonia and sleep spindle duration. Levendowski DJ, Boeve BF, Walsh CM, et al. Sleep. 2022: 45(1): A121
Keyword: Sleep EEG and neurodegenerative disease
The influence of antidepressants on non-REM hypertonia, a biomarker for Parkinsonian spectrum disorders. Levendowski DJ, Walsh CM, Boeve BF, et al. Sleep. 2022: 45(1): A120-A121.
Keyword: Sleep EEG and neurodegenerative disease
Sleep spindle duration: A potential biomarker for particular neurodegenerative disorders. Levendowski DJ, Walsh CM, Boeve BF, et al. Sleep. 2022: 45(1): A120.
Keyword: Sleep EEG and neurodegenerative disease
Investigation of sleep metrics in the characterization of neurodegenerative disease.  Levendowski DJ, Boeve BF, Neylan T, et al. Alzheimer’s & Dementia 2021: 17(S5).  DOI: 10.1002/alz.052238.
Keyword: Sleep EEG and neurodegenerative disease
Non-REM sleep with hypertonia:  A potential prodromal biomarker for α-Synuclein-related neurodegenerative disease. Levendowski DJ, Boeve BF, Shprecher D, et al. Conference of the American Academy of Neurology, San Francisco, CA 2021.
Keyword: Sleep EEG and neurodegenerative disease
Normal and abnormal stage N3 sleep in patients with cognitive impairment and/or neurodegenerative diseases. Levendowski DJ, Boeve BF, Shprecher D, et al. Conference of the American Academy of Neurology, San Francisco, CA 2021.
Keyword: Sleep EEG and neurodegenerative disease
Assessment of sleep abnormalities in patients with neurodegenerative disease using an in-home sleep profiling system. Levendowski D, Berka C, Meghdadi A etal.  SomnologieSuppl 1 2018; 16-17.
Keyword: Sleep EEG and neurodegenerative disease
Characterization of sleep abnormalities in Alzheimer’s disease and mild cognitive impairment using an in-home sleep profiling system.  Berka C, Levendowski D, Meghdadi A etal. AD/PDF ocus Meeting, 2018, Torino Italy
Keyword: Sleep EEG and neurodegenerative disease
Neurophysiological biomarkers for Alzheimer’s disease and mild cognitive impairment acquired during sleep and wake. Berka C, Meghdadi A, Rupp G, et al.  AD/PDFocus Meeting, 2018, Torino Italy
Keyword: Sleep EEG and neurodegenerative disease
Atypical sleep architecture evaluated in septic patients in the intensive care unit; a pilot study.  Kotani T, Miyashita, Mori etal. American Thoracic Society, 2019, Dallas Tx
Keyword: Sleep and ICU
Can disrupted sleep affect mortality in the mechanically ventilated critically ill?  Shah PC, Yudelevich E, Genese F, et al.  American Thoracic Society, 2016, San Francisco, CA.
Keyword: Sleep and ICU
Sleep in the ICU:  an analysis of sleep quality and quantity in mechanically ventilated patients. Yudelevich E, Fuhrman K, Ventura I, et al.  Society of Critical Care Medicine, 2016, Orlando FL.
Keyword: Sleep and ICU
The influence of sepsis on sleep architecture in the intensive care unit. Genese F, Martillo M, Ventura I, et al.  Society of Critical Care Medicine, 2016, Orlando FL.
Keyword: Sleep and ICU
Challenges of sleep in the ICU:  The significance of sedatives on sleep architecture.
Fuhrmann KA, Martillo M, Genese F, et al.:  American Thoracic Society, 2016, San Francisco, CA.
Keyword: Sleep and ICU
Multi-night EEG recordings during sleep can provide important information in managing insomnia.  Australasian Sleep Society Meeting 2015; Melbourne Australia.
Keyword: Sleep EEG and Insomnia
Night to night variability in subjective and objective sleep quality metrics in patients evaluated for chronic insomnia. Levendowski DJ, Cetel M, Rosenberg R, et al. Sleep, 2014;37:188.
Keyword: Sleep EEG and Insomnia
Night to night variabilityin sleep architecture and continuity in patients evaluated for chronic insomnia. Westbrook PR, Levendowski D, Cetel M, et al. Sleep, 2014;37:192.
Keyword: Sleep EEG and Insomnia
Comparison of objective and subjective measures of awakenings in patients evaluated for chronic insomnia. Cetel M, Rosenberg R, Levendowski D, et al.  Sleep, 2014;37:A191.
Keyword: Sleep EEG and Insomnia
Objective measures of sleep and subjective symptoms in patients evaluated for chronic insomnia, grouped by three different depression criteria.  Cunnington D, Levendowski D, Westbrook P, etal.  Australasian Sleep Society Meeting, 2014, Perth Australia.
Keyword: Sleep EEG and Mood
Differences in heart rate variability during REM and NREM sleep, a biomarker for depression?  Levendowski DJ, Cetel M, Rosenberg R, et al.  Sleep, 2014;37:187.
Keyword: Sleep EEG and Mood
Interpreting in-home sleep biomarkers based on polysomnographic reference values. Levendowski DJ, Rosenberg R, Lucey BP etal.  Sleep, 2017;40:A845.
Keyword: Sleep EEG biomarkers
Agreement between auto-scored and edited unattended in-home polysomnography.  Levendowski D, Dawson D, Levi M et al.  Sleep Medicine 2017;40;89.
Keyword: OSA diagnostic accuracy
Non-inferiority between the overall and REM-related apnea-hypopnea indexes obtained by polysomnography and a forehead worn, auto-scored system. Levendowski DJ, Henninger D, Smith J, et al. Sleep,  2016;39:A380.
Keyword: OSA diagnostic accuracy
Agreement in supine sleep duration when measured from the chest, head and neck.  Levendowski D, Veljkovic B, Ramos Angel E, et al.  30th annual meeting of the Australasian Sleep Association, Brisbane Australia, October 17-20, 2018.
Keyword: Sleep and position

Specifications

Channels
Up to 8
Power
Rechargeable Battery
Warranty
2 years
Dimensions
7cm x 4.5cm x 1.75cm
Weight, Including Batteries
71g (2.5oz)
Memory
8 GB internal
Recording Time
Up to 30 hours

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