In-Home Patient-Applied Type 2 Home Sleep Test

The Sleep Profiler PSG2TM combines the accuracy and versatility of the Sleep ProfilerTM with the cardio-respiratory signals needed for a Type 2 unattended, virtually wireless polysomnography study.  

The 13-channel system includes EEG, EOG and EMG, wireless oximetry, nasal pressure/airflow, chest and abdomen respiratory effort (RIP or piezo), forehead and finger pulse rate, head movement and position, and quantitative snoring.

The Sleep Profiler PSG2TM is the only home sleep apnea test (HSAT) that uses voice messages to assist the patient to correctly self-apply the sensors. Real-time detection of poor airflow and oximetry signal quality trigger corrective voice alerts that contribute to an industry-leading 94% success rate for a Type II study.

The web-based software enables selection of either 3% or 4% desaturation criteria, with auto-scored apnea/hypopnea indexes based on both AASM²⁰¹² and AASM²⁰⁰⁷ scoring rules and automated detection of poor signal quality.

Features

Sleep-Disordered Breathing

  • Detection of apneas, hypopnea-desats, and hypopnea-arousals
  • Differentiation between obstructive and central apneas
  • Hypoxemic exposure during sleep
  • REM and positional influence on OSA severity
  • Frequency and intensity of positional snoring
  • Power spectral characteristics of the sleep stages

Applications

Clinical:
  • PSG2 enables clinicians to easily and accurately conduct unattended PSG studies to:
  • Rule out potential false negative Type III study results
  • Provide PSG studies to patients who are:
  • hospitalized and need to qualify for CPAP reimbursement
  • in need based on co-morbidities, but unable to schedule a lab-based study
  • unable to sleep during a laboratory PSG
  • suspected of upper airway resistance syndrome
  • suspected of having neurodegenerative disease
Research:
  • PSG2 provides researcher the capability to assess the interaction between sleep architecture, hypoxemia, and sleeping position on sleep disordered breathing severity with variables that include:
  • REM and Non-REM apnea/hypopnea, apnea, and hypopnea indexes
  • Snoring above 30, 40, 50, and 60 dB by position
  • Number of hypopneas confirmed by arousals vs. desaturations by position
  • Number of apneas and hypopnea events by position
  • 3% and 4% oxygen desaturation indexes by position

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 13
Power
Rechargeable Battery
Warranty
2 years
Weight, including WristOx® and Effort Belts
up to 388g (13.7oz)
Memory
8 GB internal
Recording Time
Up to 30 hours
Airflow range
± 2cm H₂O
Oximetry accuracy
± 2% at one standard deviation from 70% to 100%

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