Dataset Information

An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea.

ABSTRACT: We conducted an economic analysis of the HomePAP study, a multicenter randomized clinical trial that compared home-based versus laboratory-based testing for the diagnosis and management of obstructive sleep apnea (OSA).A cost-minimization analysis from the payer and provider perspectives was performed, given that 3-mo clinical outcomes were equivalent.Seven academic sleep centers.There were 373 subjects at high risk for moderate to severe OSA.Subjects were randomized to either home-based limited channel portable monitoring followed by unattended autotitration with continuous positive airway pressure (CPAP), versus a traditional pathway of in-laboratory sleep study and CPAP titration.From the payer perspective, per subject costs for the laboratory-based pathway were $1,840 (95% confidence interval [CI] $1,660, $2,015) compared to $1,575 (95% CI $1,439, $1,716) for the home-based pathway under the base case. Costs were $264 (95% CI $39, $496, P = 0.02) in favor of the home arm. From the provider perspective, per subject costs for the laboratory arm were $1,697 (95% CI $1,566, $1,826) compared to $1,736 (95% CI $1,621, $1,857) in the home arm, for a difference of $40 (95% CI -$213, $142, P = 0.66) in favor of the laboratory arm under the base case. The provider operating margin was $142 (95% CI $85, $202,P < 0.01) in the laboratory arm, compared to a loss of -$161 (95% CI -$202, -$120, P < 0.01) in the home arm.For payers, a home-based diagnostic pathway for obstructive sleep apnea with robust patient support incurs fewer costs than a laboratory-based pathway. For providers, costs are comparable if not higher, resulting in a negative operating margin.NCT00642486.

SUBMITTER: Kim RD

PROVIDER: S-EPMC4481018 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea.

Kim Richard D RD Kapur Vishesh K VK Redline-Bruch Julie J Rueschman Michael M Auckley Dennis H DH Benca Ruth M RM Foldvary-Schafer Nancy R NR Iber Conrad C Zee Phyllis C PC Rosen Carol L CL Redline Susan S Ramsey Scott D SD

Sleep 20150701 7

<h4>Study objectives</h4>We conducted an economic analysis of the HomePAP study, a multicenter randomized clinical trial that compared home-based versus laboratory-based testing for the diagnosis and management of obstructive sleep apnea (OSA).<h4>Design</h4>A cost-minimization analysis from the payer and provider perspectives was performed, given that 3-mo clinical outcomes were equivalent.<h4>Setting</h4>Seven academic sleep centers.<h4>Participants</h4>There were 373 subjects at high risk for ...[more]

PMID: 26118558

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Project description:BackgroundObstructive sleep apnea is associated with hypertension, inflammation, and increased cardiovascular risk. Continuous positive airway pressure (CPAP) reduces blood pressure, but adherence is often suboptimal, and the benefit beyond management of conventional risk factors is uncertain. Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea, we evaluated the effects of nocturnal supplemental oxygen and CPAP on markers of cardiovascular risk.MethodsWe conducted a randomized, controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices. Patients were screened for obstructive sleep apnea with the use of the Berlin questionnaire, and home sleep testing was used to establish the diagnosis. Participants with an apnea-hypopnea index of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone (the control group) or, in addition to education, either CPAP or nocturnal supplemental oxygen. Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment. The primary outcome was 24-hour mean arterial pressure.ResultsOf 318 patients who underwent randomization, 281 (88%) could be evaluated for ambulatory blood pressure at both baseline and follow-up. On average, the 24-hour mean arterial pressure at 12 weeks was lower in the group receiving CPAP than in the control group (-2.4 mm Hg; 95% confidence interval [CI], -4.7 to -0.1; P=0.04) or the group receiving supplemental oxygen (-2.8 mm Hg; 95% CI, -5.1 to -0.5; P=0.02). There was no significant difference in the 24-hour mean arterial pressure between the control group and the group receiving oxygen. A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis.ConclusionsIn patients with cardiovascular disease or multiple cardiovascular risk factors, the treatment of obstructive sleep apnea with CPAP, but not nocturnal supplemental oxygen, resulted in a significant reduction in blood pressure. (Funded by the National Heart, Lung, and Blood Institute and others; HeartBEAT ClinicalTrials.gov number, NCT01086800 .).

Project description:Study objectivesWe investigated the diagnostic accuracy for the identification of obstructive sleep apnea (OSA) and its severity of a noninvasive technology based on image processing (SleepWise).MethodsThis is an observational, prospective study to evaluate the degree of agreement between polysomnography (PSG) and SleepWise. We recruited 56 consecutive subjects with suspected OSA who were referred as outpatients to the Sleep Unit of the Hospital Universitari Germans Trias i Pujol (HUGTiP) from January 2013 to January 2014. All patients underwent laboratory PSG and image processing with SleepWise simultaneously the same night. Both PSG and SleepWise analyses were carried independently and blindly.ResultsWe analyzed 50 of the 56 patients recruited. OSA was diagnosed through PSG in a total of 44 patients (88%) with a median apnea-hypopnea index (AHI) of 25.35 (24.9). According to SleepWise, 45 patients (90%) met the criteria for a diagnosis of OSA, with a median AHI of 22.8 (22.03). An analysis of the ability of PSG and SleepWise to classify patients by severity on the basis of their AHI shows that the two diagnostic systems distribute the different groups similarly. According to PSG, 23 patients (46%) had a diagnosis of severe OSA, 11 patients (22%) moderate OSA, and 10 patients (20%) mild OSA. According to SleepWise, 20, 13, and 12 patients (40%, 26%, and 24%, respectively) had a diagnosis of severe, moderate, and mild OSA respectively. For OSA diagnosis, SleepWise was found to have sensitivity of 100% and specificity of 83% in relation to PSG. The positive predictive value was 97% and the negative predictive value was 100%. The Bland-Altman plot comparing the mean AHI values obtained through PSG and SleepWise shows very good agreement between the two diagnostic techniques, with a bias of -3.85, a standard error of 12.18, and a confidence interval of -0.39 to -7.31.ConclusionsSleepWise was reasonably accurate for noninvasive and automatic diagnosis of OSA in outpatients. SleepWise determined the severity of OSA with high reliability. The current study including simultaneous laboratory PSG and SleepWise processing image is proposed as a reasonable validation standard.

Project description:There is increasing evidence that mandibular advancement devices (MADs) can be an effective treatment for some patients with obstructive sleep apnea, a highly prevalent chronic disease. In this study, the objectives were to objectively assess the effectiveness of MAD therapy using a limited channel recorder, and to develop a model for identifying patients who may be appropriate for MAD therapy as the initial treatment option. Thirty patients were prospectively recruited and studied at two independent dentist offices and the participants' homes. Subjects wore the ARES Unicorder for two nights before insertion of the MAD, and again when the dentist determined that the patient had reached the titration endpoint. Self-reported measures of depression, sleepiness, and quality of life were obtained pre- and posttreatment. The reviewer was blinded to the study status while the physiological signals were being visually inspected. Significant reductions in the apnea/hypopnea index (AHI), hypoxemia measures, and snoring level were observed posttreatment. Twenty-seven of the 30 (90%) patients had a posttreatment AHI (using a 4% desaturation for hypopneas) below a clinical cut-off of 10. All but one patient (97%) exhibited at least a 50% decrease in AHI or had a posttreatment AHI < or = 10. Significant differences in body mass index, weight, and neck circumference in patients with posttreatment AHIs above and below a clinical cut-off of five were identified. The linear regression used to predict the posttreatment AHI using pretreatment data resulted in an R(2) of 0.68. The model correctly predicted two patients who were unable to obtain a posttreatment AHI of 10 or less. This study was designed to demonstrate two models of collaboration between a dental sleep medicine specialist and a sleep medicine physician in the monitoring of a patient treated with a MAD. The outcome data suggest that the limited channel recording system can be used as an alternative to laboratory polysomnography to reduce the cost of MAD treatment, and to improve the quality and consistency of posttreatment patient care.

Project description:Study objectivesThe objective of the study is to validate the performance of Belun Ring Platform, a novel home sleep apnea testing system using a patented pulse oximeter sensor and a proprietary cloud-based neural networks algorithm.MethodsThe Belun Ring captures oxygen saturation, photoplethysmography, and accelerometer signals. The Belun Ring total sleep time is derived from features extracted from accelerometer, oxygen saturation, and photoplethysmography signals. The Belun Ring respiratory event index is derived from Belun Ring total sleep time and features extracted from heart rate variability and oxygen saturation changes. A total of 50 adults without significant cardiopulmonary or neuromuscular comorbidities and heart rate affecting medications were evaluated. In-lab sleep studies were performed simultaneously with the Ring and the studies were manually scored using the American Academy of Sleep Medicine Scoring Manual 4% desaturation criteria.ResultsThe Belun Ring respiratory event index correlated well with the polysomnography-apnea-hypopnea index (AHI; r = .894, P < .001). The sensitivity and specificity in categorizing AHI ≥ 15 events/h were 0.85 and 0.87, respectively, and the positive predictive value and negative predictive value were 0.88 and 0.83, respectively. The Belun Ring total sleep time also correlated well with the polysomnography-total sleep time (r = .945, P < .001). Although the Belun Ring Platform has a good overall performance, it tends to overestimate AHI in individuals with AHI under 15 events/h and underestimate AHI in those with AHI over 15 events/h. Conclusions: In this proof-of-concept study, the Belun Ring Platform demonstrated a reasonable accuracy in predicting AHI and total sleep time in patients without significant comorbidities and heart rate-affecting medications.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT04121923; Identifier: NCT04121923.

Dataset Information

An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea.

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An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea.

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