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Cited by 142Obstructive Sleep Apnea ResearchSleep and related disordersNon-Invasive Vital Sign Monitoring

Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome

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Santos-Silva, Rogerio, Sartori, Denis E., Truksinas, Viviane, Truksinas, Eveli, Alonso, Fabiana F. F. D, Tufik, Sergio, Bittencourt, Lia R. A.·2009·Sleep
DOI 10.1093/sleep/32.5.629PMC PMC2675898
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Abstract

STUDY OBJECTIVE: To evaluate if a portable monitor could accurately measure the apnea-hypopnea index (AHI) in patients with a suspicion of obstructive sleep apnea (OSA). DESIGN: Prospective and randomized. SETTING: Sleep laboratory. PARTICIPANTS: 80 participants: 70 patients with clinical OSA suspicion and 10 subjects without suspicion of OSA. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Three-order randomized evaluations were performed: (1) STD (Stardust II) used at the participants' home (STD home), (2) STD used simultaneously with PSG in the sleep lab (STD+PSG lab), and (3) PSG performed without the STD (PSG lab). Four AHI values were generated and analyzed: (a) STD home; (b) STD from STD+PSG lab; (c) PSG from STD+PSG (named PSG+STD lab); and (d) PSG lab. Two technicians, blinded to study details, performed the analyses of all evaluations. There was a strong correlation between AHI from the STD and PSG recordings for all 4 AHI values (all correlations above 0.87). Sensitivity, specificity, and positive and negative predictive values at AHI cut-off values of 5, 15, and 30 events/hour were calculated. AHI values from the PSG lab and PSG+STD lab were compared to STD home and STD+PSG lab and showed the best results when STD and PSG were performed simultaneously. In all analyses, the area under ROC curve was at least 0.90. With multiple comparisons, diagnostic agreement was between 91% and 75%. The Bland Altman analyses showed strong agreement between AHI values from the STD and PSG recordings, especially when comparing the AHI from simultaneous STD and PSG recordings. CONCLUSION: These data suggest that the STD is accurate in confirming the diagnosis of OSA where there is a suspicion of the disorder. Better agreement occurred during simultaneous recordings.

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  • When using an AHI ≥ 5 cutoff, accuracy of Type 3 HSAT devices in a high-risk population (assuming a prevalence of 87%) ranged from 84% to 91%, whereas in a low-risk population (assuming a prevalence of 55%) accuracy ranged from 70% to 78%.

    “When using an AHI ≥ 5 cutoff, accuracy in a high-risk population (assuming a prevalence of 87%) ranged from 84% to 91%, whereas in a low-risk population (assuming a prevalence of 55%) accuracy ranged from 70% to 78% based on the seven studies”

    From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [90]

    The Statistical Analysis and Results sections report testing one portable monitor at an AHI cutoff of 5 and comparing its results with polysomnography. They do not report accuracy ranges of 84%–91% and 70%–78% for populations with assumed prevalences of 87% and 55%, or an analysis based on seven studies. Page numbers are unavailable in our copy. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • Using a cutoff of AHI ≥ 15, the accuracy of Type 3 HSAT devices in a high-risk population ranged from 65% to 91%, based on six studies.

    “Using a cutoff of AHI ≥ 15, the accuracy of these devices in a high-risk population ranged from 65% to 91%, based on six studies”

    From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [90]

    The Results section reports evaluation of a portable monitor at an AHI cutoff of 15, and the Discussion describes its performance in patients from a sleep outpatient setting. This is a validation of the Stardust II, not a six-study estimate of Type 3 device accuracy; the cited passages do not report a 65%–91% range at that cutoff. (LLM, conf=0.86)

    Experimental — accuracy not yet measured

  • Seven studies evaluated the performance of Type 3 HSAT devices against PSG, with AHI cutoffs varying across studies.

    “Seven studies evaluated the performance of Type 3 HSAT devices against PSG, but the AHI cutoffs employed varied across studies, resulting in sub-grouping by AHI cutoffs for our analyses.”

    From Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline (2017) · cites this paper as [90]

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Cited by

Sorted by citations

Authors
Santos-Silva, R., Sartori, D. E., Truksinas, V., Truksinas, E., Alonso, F. F. F. D., Tufik, S., & Bittencourt, L. R. A.
Affiliations
Universidade Federal de São Paulo (BR)
Corresponding author
Bittencourt, Lia R. A.
ORCID
Venue
Sleep
Publisher
Oxford University Press (OUP)
Published
2009-05
Volume
32
Issue
5
Pages
629-636
ISSN
  • 0161-8105 (ISSN-L)
  • 1550-9109
DOI
10.1093/sleep/32.5.629
PMC
PMC2675898
OpenAlex
W154426793
Cited by
142
References
1
Citations by year
2026: 4 · 2025: 2 · 2024: 4 · 2023: 5 · 2022: 6 · 2021: 9 · 2020: 11 · 2019: 9 · 2018: 9 · 2017: 8 · 2016: 9 · 2015: 9 · 2014: 11 · 2013: 10 · 2012: 14
FWCI
7.57
Type
journal article
Language
en
Open access
Locations
  • SLEEP (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Americanae (AECID Library) (submittedVersion, other-oa)
  • LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
Funders
Associação Fundo de Incentivo à Pesquisa
Topics
  • Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
  • Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
Keywords
obstructive sleep apnea, apnea-hypopnea index, home sleep monitoring, home sleep testing, polysomnography, diagnostic accuracy, OSA diagnosis
MeSH terms
Adult, Brazil, Equipment Design, Female, Humans, Male, Middle Aged, Prospective Studies, Sensitivity and Specificity, Polysomnography, Monitoring, Ambulatory, Sleep Apnea, Obstructive

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