The utility of home sleep apnea tests in patients with low versus high pre-test probability for moderate to severe OSA

Goldstein, Cathy; Karnib, Hala; Williams, Katherine; Virk, Zunaira; Shamim-Uzzaman, Afifa

doi:10.1007/s11325-017-1594-2

Cited by 14 publications

(4 citation statements)

References 67 publications

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“…Demand for at-home sleep testing and HSATs has increased since the coronavirus 2019 (COVID-19) pandemic 14 . However, whether HSATs can replace in-lab PSG remains a topic of controversy owing to concerns about their performance 15 ; in particular, they often do not measure EEG, EOG, or chin EMG, causing difficulty in accurately measuring sleep stages and cortical arousal 16 , 17 . A recent meta-analysis of HSAT accuracy showed that the apnea–hypopnea index (AHI) assessment with HSAT has a significant number of false negatives and false positives, with significant interproduct variability 18 .…”

Section: Introductionmentioning

confidence: 99%

FDA-cleared home sleep apnea testing devices

Park,

Wang,

Shin

2024

npj Digit. Med.

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The demand for home sleep apnea testing (HSAT) devices is escalating, particularly in the context of the coronavirus 2019 (COVID-19) pandemic. The absence of standardized development and verification procedures poses a significant challenge. This study meticulously analyzed the approval process characteristics of HSAT devices by the U.S. Food and Drug Administration (FDA) from September 1, 2003, to September 1, 2023, with a primary focus on ensuring safety and clinical effectiveness. We examined 58 reports out of 1046 that underwent FDA clearance via the 510(k) and de novo pathways. A substantial surge in certifications after the 2022 pandemic was observed. Type-3 devices dominated, signifying a growing trend for both home and clinical use. Key measurement items included respiration and sleep analysis, with the apnea–hypopnea index (AHI) and sleep stage emerging as pivotal indicators. The majority of FDA-cleared HSAT devices adhered to electrical safety and biocompatibility standards. Critical considerations encompass performance and function testing, usability, and cybersecurity. This study emphasized the nearly indispensable role of clinical trials in ensuring the clinical effectiveness of HSAT devices. Future studies should propose guidances that specify stringent requirements, robust clinical trial designs, and comprehensive performance criteria to guarantee the minimum safety and clinical effectiveness of HSATs.

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Section: Introductionmentioning

confidence: 99%

FDA-cleared home sleep apnea testing devices

Park,

Wang,

Shin

2024

npj Digit. Med.

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“…All of these factors contribute to the poor diagnosed prevalence. Portable sleep monitor is a cost-effective alternative to PSG, but it is still more expensive and complicated compared with questionnaire survey, and it may underestimate the severity of OSA and potentially yield false-negative results ( 8 ). Thus, a simple screening tool for moderate-to-severe OSA is urgently required.…”

Section: Introductionmentioning

confidence: 99%

An effective model for screening moderate-to-severe obstructive sleep apnea based on the STOP-BANG questionnaire

Wang¹,

Xu²,

Jiang³

et al. 2022

J Thorac Dis

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Background: This study aimed to develop a more effective screening model for moderate-to-severe obstructive sleep apnea (OSA) based on the best tool among Epworth Sleepiness Scale (ESS), NoSAS score and STOP-BANG questionnaire (SBQ). Methods: This study screened 2,031 consecutive subjects referred with suspected OSA from 2012 to 2016, including the test cohort from 2012 to 2014 and the validation cohort from 2014 to 2016. Anthropometric measurements, polysomnographic data, ESS, NoSAS scores and SBQ scores were recorded. Receiver operating characteristic curve analyses were performed and the final predictive models were verified in a validation cohort.Results: A total of 1,840 adults were finally included. The performance of ESS, NoSAS score and SBQ in screening OSA was compared. The diagnostic accuracy of SBQ was superior to ESS and NoSAS. A predictive model based on SBQ yielded an area under the curve (AUC) of 0.931 (95% CI: 0.915-0.946), and the sensitivity and specificity were 84.47 (95% CI: 81.4-87.2) and 87.36 (95% CI: 83.9-90.3) respectively.In the validation cohort, the AUC was 0.955 (95% CI: 0.938-0.969), with a sensitivity and specificity of 86.79 (95% CI: 83.2-89.9) and 90.88 (95% CI: 87.2-93.8) respectively. In addition, the model performed moderately in screening mild OSA with the AUC being 0.771 (95% CI: 0.721-0.815). Conclusions:The SBQ was effective in screening moderate-to-severe OSA. And a SBQ -based predictive model afforded excellent diagnostic efficacy, which could be applied in clinical practice.

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“…A review pointed out that HSAT for detecting severe OSA syndrome was AUC 0.80 (95% CI, 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90). [18,19]…”

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confidence: 99%

The Relation between Gastroesophageal Reflux Disease and the Obstructive Sleep Apnea and the Effects of Continuous Positive Airway Pressure Treatment

Deng

et al. 2022

Preprint

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Background: Patients with OSA have a higher risk of GERD than non-OSA patients. However, there is a controversy between the OSA and GERD. Herein, we evaluated the prevalence and possible risk factors of GERD in OSA. We also observed the efficacy of continuous positive airway pressure (CPAP) therapy on these patients. Method: Home Sleep Apnea Test (HAST) and gastroesophageal reflux disease questionnaire (GERDQ) are used to diagnose OSA and GERD. A total of 600 OSA patients were concluded in this cross-sectional study. Of the patients with OSA complicated with GERD, 36 received CPAP, 24 received CPAP + proton pump inhibitor (PPI), and 33 received PPI. We followed patients with OSA complicated with GERD for 8 weeks. Result: This study identified a significant relationship between OSA and GERD, with a OR of 2.76 (95%CI 1.42-5.36, P=0.02). The prevalence of GERD in patients with mild, moderate, and severe OSA was 14.9%, 15.9%, and 56.9%, respectively. After 8 weeks of treatment, the GERDQ in the CPAP group was 6.89±1.14. The duration of symptom improvement in CPAP group was 5.43±2.02 weeks. The duration of symptom improvement in CPAP+PPI group was 4.23±1.6 weeks. and higher PPI discontinuation rate in CPAP+PPI group is 54.2%, and PPI group is 27.3%. Conclusion: OSA was independently associated with GERD. CPAP improved GER symptoms compared with the no-treatment group. CPAP+PPI treatment improved GERD more rapidly than PPI alone, and CPAP treatment was an independent protective factor for GERD.

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The utility of home sleep apnea tests in patients with low versus high pre-test probability for moderate to severe OSA

Abstract: HSATs should be reserved for individuals with high pre-test probability for moderate to severe disease as opposed to any individual with suspected OSA.

Cited by 14 publications

References 67 publications

FDA-cleared home sleep apnea testing devices

FDA-cleared home sleep apnea testing devices

An effective model for screening moderate-to-severe obstructive sleep apnea based on the STOP-BANG questionnaire

The Relation between Gastroesophageal Reflux Disease and the Obstructive Sleep Apnea and the Effects of Continuous Positive Airway Pressure Treatment

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