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Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea.

ABSTRACT: To validate the ApneaLINK (AL) as an accurate tool for determining the presence of obstructive sleep apnea (OSA) in an at-risk sleep clinic population in a home test environment.Consecutive participants referred with the suspicion of OSA were evaluated in the home with the AL portable monitor (AL Home), followed by simultaneous data collection with diagnostic polysomnography (PSG) and AL in the sleep laboratory (AL Lab). Prevalence, sensitivity, specificity, and ROC curves were calculated for PSG vs. AL Lab, PSG vs. AL Home, and AL Lab vs. AL Home test. Pearson correlations and Bland-Altman plots were constructed.Fifty-three (55% female) participants completed the entire study. The mean age of the population was 45.1 ± 11.3 years, and body mass index was 35.9 ± 9.1 kg/m(2). The prevalence of an apnea hypopnea index (AHI) ? 15 in the cohort was 35.9%. The results demonstrated a high sensitivity and specificity of the AL respiratory disturbance index (RDI-AL) compared with the AHI from the PSG. The AL Lab had the highest sensitivity and specificity at RDI-AL values ? 20 events/h (sensitivity 100%, specificity 92.5%). The AL Home was most sensitive and specific at an RDI-AL ? 20 events/h (sensitivity 76.9%, specificity 92.5%). The Pearson correlations for PSG vs. AL Lab and PSG vs. AL Home were ? = 0.88 and ? = 0.82, respectively. The Bland-Altman Plots demonstrated good agreement between the methodologies.The AL home test is an accurate alternative to PSG in sleep clinic populations at risk for moderate and severe OSA.clinicaltrials.gov ID: NCT00354614.

SUBMITTER: Oktay B

PROVIDER: S-EPMC3160740 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea.

Oktay Burcu B Rice Thomas B TB Atwood Charles W CW Passero Michael M Gupta Neeraj N Givelber Rachel R Drumheller Oliver J OJ Houck Patricia P Gordon Nancy N Strollo Patrick J PJ

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20110801 4

<h4>Study objective</h4>To validate the ApneaLINK (AL) as an accurate tool for determining the presence of obstructive sleep apnea (OSA) in an at-risk sleep clinic population in a home test environment.<h4>Methods</h4>Consecutive participants referred with the suspicion of OSA were evaluated in the home with the AL portable monitor (AL Home), followed by simultaneous data collection with diagnostic polysomnography (PSG) and AL in the sleep laboratory (AL Lab). Prevalence, sensitivity, specificit ...[more]

PMID: 21897775

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Project description:Study objectivesThe efficacy of portable-monitor (PM) sleep testing in children is not well understood. While most studies have evaluated PM in a lab setting, the utility of PM in the home environment is relatively unknown. We sought to determine whether home PM accurately diagnoses obstructive sleep apnea in adolescents and to assess patient satisfaction with home PM sleep testing.MethodsWe evaluated adolescents (age 12-18 years) with suspected obstructive sleep apnea using a PM device. In addition to in-laboratory polysomnography (PSG), all participants had PM testing performed twice, once in their home and once concurrent to in-laboratory PSG. PM was compared to PSG using 2 primary outcomes: the apnea-hypopnea index and oxygen desaturation index. All participants were approached for interview to evaluate their experience with PM sleep testing.ResultsTwenty adolescents participated. Bland-Altman analysis comparing the apnea-hypopnea index and oxygen desaturation index determined by home or in-laboratory PM to in-laboratory PSG revealed mostly agreement; however, some deviations were observed when either parameter was markedly increased. While PM testing tended to underestimate the apnea-hypopnea index, the diagnostic agreement between home PM and PSG was 80% (by the White-Westbrook method). Most preferred PM to PSG and found PM easy to very easy to set up.ConclusionsIn a small cohort of adolescents, our study supports the application of home PM in the diagnosis of suspected obstructive sleep apnea. Until studies implementing PM using larger cohorts become readily available, the findings from this preliminary study could contribute to adolescents receiving sleep apnea therapy more promptly.Clinical trial registrationRegistry: ClinicalTrials.gov; Identifier: NCT03748771. At the time of issue publication, this registration is not publicly available because the trial includes a device that is not approved or cleared for use in pediatric populations. Once the device is FDA cleared, the registration will become public.

Project description:IntroductionHome single-channel nasal pressure (HNP) may be an alternative to polysomnography (PSG) for obstructive sleep apnea (OSA) diagnosis, but no cost studies have yet been carried out. Automatic scoring is simpler but generally less effective than manual scoring.ObjectivesTo determine the diagnostic efficacy and cost of both scorings (automatic and manual) compared with PSG, taking as a polysomnographic OSA diagnosis several apnea-hypopnea index (AHI) cutoff points.MethodsWe included suspected OSA patients in a multicenter study. They were randomized to home and hospital protocols. We constructed receiver operating characteristic (ROC) curves for both scorings. Diagnostic efficacy was explored for several HNP AHI cutoff points, and costs were calculated for equally effective alternatives.ResultsOf 787 randomized patients, 752 underwent HNP. Manual scoring produced better ROC curves than automatic for AHI < 15; similar curves were obtained for AHI ≥ 15. A valid HNP with manual scoring would determine the presence of OSA (or otherwise) in 90% of patients with a polysomnographic AHI ≥ 5 cutoff point, in 74% of patients with a polysomnographic AHI ≥ 10 cutoff point, and in 61% of patients with a polysomnographic AHI ≥ 15 cutoff point. In the same way, a valid HNP with automatic scoring would determine the presence of OSA (or otherwise) in 73% of patients with a polysomnographic AHI ≥ 5 cutoff point, in 64% of patients with a polysomnographic AHI ≥ 10 cutoff point, and in 57% of patients with a polysomnographic AHI ≥ 15 cutoff point. The costs of either HNP approaches were 40% to 70% lower than those of PSG at the same level of diagnostic efficacy. Manual HNP had the lowest cost for low polysomnographic AHI levels (≥ 5 and ≥ 10), and manual and automatic scorings had similar costs for higher polysomnographic cutoff points (AHI ≥ 15) of diagnosis.ConclusionHome single-channel nasal pressure (HNP) is a cheaper alternative than polysomnography for obstructive sleep apnea diagnosis. HNP with manual scoring seems to have better diagnostic accuracy and a lower cost than automatic scoring for patients with low apnea-hypopnea index (AHI) levels, although automatic scoring has similar diagnostic accuracy and cost as manual scoring for intermediate and high AHI levels. Therefore, automatic scoring can be appropriately used, although diagnostic efficacy could improve if we carried out manual scoring on patients with AHI < 15.Clinical trials informationClinicaltrials.gov identifier: NCT01347398.

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Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea.

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Evaluation of a single-channel portable monitor for the diagnosis of obstructive sleep apnea.

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