2020
DOI: 10.5664/jcsm.8226
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Study design considerations for sleep-disordered breathing devices

Abstract: In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop fo… Show more

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Cited by 13 publications
(6 citation statements)
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“…Third, there are no universally agreed upon AHI and RDI values for diagnosing or grading the severity of OSA in pediatric patients due to the significant anatomic heterogeneity exhibited across age groups [12,16]. Lastly, the results obtained from PSG have been demonstrated to lack consistency across sessions potentially limiting the quality of our data [23][24][25][26][27].…”
Section: Discussionmentioning
confidence: 99%
“…Third, there are no universally agreed upon AHI and RDI values for diagnosing or grading the severity of OSA in pediatric patients due to the significant anatomic heterogeneity exhibited across age groups [12,16]. Lastly, the results obtained from PSG have been demonstrated to lack consistency across sessions potentially limiting the quality of our data [23][24][25][26][27].…”
Section: Discussionmentioning
confidence: 99%
“…Other expert panels have recognized this problem and recommended against the inclusion of arousals in scoring until greater interscorer reliability has been achieved. 13 More importantly, the position paper cited only two studies to support the contention that arousal-based scoring identifies patients who benefit from treatment. Both were observational, neither had a control group, and combined they included only 50 patients.…”
Section: Arousals Vs Desaturation Criterion For Hypopneas: Association With Outcomes and Response To Treatmentmentioning
confidence: 99%
“…The current gold standard is a laboratory polysomnography (PSG) system which includes: respiratory effort, oronasal airflow, and pulse oximetry to monitor respiration, brain, cardiac, and eye activity to assess sleep stages and arousals, plus other sensors for muscular activity and body movements. Other systems, such as home sleep apnea tests (HSATs), can simplify multiple nights of recordings by measuring sleep at home and reduce the psychological lab effect, but compromise the number of signals available, depending on the HSAT class (Ferber et al 1994, Mann et al 2020.…”
Section: Introductionmentioning
confidence: 99%