Comparison of in-laboratory and home diagnosis of sleep apnea using a cordless portable acoustic device.

BACKGROUND AND OBJECTIVES Sleep apnea (SA) is a common, serious, but underdiagnosed condition. There is a need for more accessible and economic means of diagnosing SA in the home. The aim of this study was to test the validity of a cordless acoustic portable device (BresoDx™) for home diagnosis of SA compared with standard polysomnography (PSG). METHODS A total of 135 subjects underwent full overnight PSG and simultaneous recording of breath sounds by BresoDx in the sleep laboratory. Acoustic data extracted from BresoDx were analyzed using validated computer acoustic algorithms. The PSG-derived apnea-hypopnea index (AHI-p) and the acoustic AHI (AHI-a) were calculated and compared. A subset of 100 subjects used the device in a subsequent night in their home from which home AHI (AHI-h) was determined. RESULTS The correlation between AHI-a and simultaneous AHI-p was 95.2% and diagnostic accuracy of BresoDx ranged between 88.9% and 93.3% around AHI cutoffs of 5-15. In the home, AHI-h did not differ significantly from AHI-p (p = 0.60). Using an AHI-p cutoff ≥ 10 BresoDx's accuracy was 81%. Of the 100 subjects, 81 (81%) had low inter-night variability measured by a difference between home AHI-h and PSG AHI-p < 10 event/h, while 19% had higher inter-night variability. CONCLUSION AHI determined using BresoDx was in excellent agreement with simultaneous AHI-p. The majority of patients had a consistent AHI in their subsequent home study with very good overall diagnostic accuracy. We conclude that BresoDx is a reliable device for diagnosing SA that can be used by subjects, unattended in their own homes.

[1]  V. Kapur,et al.  Obstructive sleep apnea devices for out-of-center (OOC) testing: technology evaluation. , 2011, Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine.

[2]  A. J. Block,et al.  Consistency of respiratory measurements from night to night during the sleep of elderly men. , 1989, Chest.

[3]  Laura Wexler,et al.  Central sleep apnea, right ventricular dysfunction, and low diastolic blood pressure are predictors of mortality in systolic heart failure. , 2007, Journal of the American College of Cardiology.

[4]  J. Floras,et al.  Continuous positive airway pressure increases heart rate variability in heart failure patients with obstructive sleep apnoea. , 2008, Clinical science.

[5]  T. Young,et al.  The occurrence of sleep-disordered breathing among middle-aged adults. , 1993, The New England journal of medicine.

[6]  T. Young,et al.  Sleep-disordered breathing and motor vehicle accidents in a population-based sample of employed adults. , 1997, Sleep.

[7]  A Noseda,et al.  Mild to moderate sleep respiratory events: one negative night may not be enough. , 2000, Chest.

[8]  A. Rechtschaffen,et al.  A manual of standardized terminology, technique and scoring system for sleep stages of human subjects , 1968 .

[9]  Daniel J. Levendowski,et al.  Assessment of the test–retest reliability of laboratory polysomnography , 2009, Sleep and Breathing.

[10]  T. D. Bradley,et al.  Effect of below-the-knee compression stockings on severity of obstructive sleep apnea. , 2015, Sleep medicine.

[11]  T. Young,et al.  Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. , 1997, Sleep.

[12]  C. Guilleminault,et al.  EEG arousals: scoring rules and examples: a preliminary report from the Sleep Disorders Atlas Task Force of the American Sleep Disorders Association. , 1992, Sleep.

[13]  T Douglas Bradley,et al.  Central sleep apnea and Cheyne-Stokes respiration. , 2008, Proceedings of the American Thoracic Society.

[14]  Jose M Marin,et al.  Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study , 2005, The Lancet.

[15]  J. Floras,et al.  Effect of continuous positive airway pressure on ventricular ectopy in heart failure patients with obstructive sleep apnoea , 2005, Thorax.

[16]  A. Chediak,et al.  Nightly variability in the indices of sleep-disordered breathing in men being evaluated for impotence with consecutive night polysomnograms. , 1996, Sleep.

[17]  D. Bliwise,et al.  Factors associated with nightly variability in sleep-disordered breathing in the elderly. , 1991, Chest.

[18]  T. Bradley,et al.  Sleep Apnea and Cardiovascular Disease , 2001 .

[19]  A. Rechtschaffen A manual of standardized terminology, techniques and scoring system for sleep of human subjects , 1968 .

[20]  J. Floras,et al.  Inhibition of awake sympathetic nerve activity of heart failure patients with obstructive sleep apnea by nocturnal continuous positive airway pressure. , 2005, Journal of the American College of Cardiology.

[21]  J. Floras,et al.  Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction. , 2009, Journal of cardiac failure.

[22]  A. Chesson,et al.  The American Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications , 2007 .

[23]  Alexander Levchenko,et al.  A system for portable sleep apnea diagnosis using an embedded data capturing module , 2013, Journal of Clinical Monitoring and Computing.

[24]  Terry Young,et al.  Association of sleep-disordered breathing and the occurrence of stroke. , 2005, American journal of respiratory and critical care medicine.

[25]  S. Kuna Portable-monitor testing: an alternative strategy for managing patients with obstructive sleep apnea. , 2010, Respiratory care.

[26]  T Douglas Bradley,et al.  Cardiovascular effects of continuous positive airway pressure in patients with heart failure and obstructive sleep apnea. , 2003, The New England journal of medicine.

[27]  J. Manfreda,et al.  Cardiovascular medication use in patients with undiagnosed obstructive sleep apnoea , 2002, Thorax.

[28]  J. Floras,et al.  Sustained effect of continuous positive airway pressure on baroreflex sensitivity in congestive heart failure patients with obstructive sleep apnea , 2008, Journal of hypertension.

[29]  T. Douglas Bradley,et al.  Sleep Apnea and Heart Failure: Part I: Obstructive Sleep Apnea , 2003, Circulation.

[30]  T. Young,et al.  Epidemiology of obstructive sleep apnea: a population health perspective. , 2002, American journal of respiratory and critical care medicine.

[31]  Olivier Mairesse,et al.  Is a one-night stay in the lab really enough to conclude? First-night effect and night-to-night variability in polysomnographic recordings among different clinical population samples , 2012, Psychiatry Research.

[32]  H. Alshaer,et al.  Validation of an automated algorithm for detecting apneas and hypopneas by acoustic analysis of breath sounds. , 2013, Sleep medicine.