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      Pilot Randomized Trial of the Effect of Wireless Telemonitoring on Compliance and Treatment Efficacy in Obstructive Sleep Apnea

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          Abstract

          Background

          Obstructive sleep apnea (OSA) is a prevalent and serious medical condition characterized by repeated complete or partial obstructions of the upper airway during sleep and is prevalent in 2% to 4% of working middle-aged adults. Nasal continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA. Because compliance rates with CPAP therapy are disappointingly low, effective interventions are needed to improve CPAP compliance among patients diagnosed with OSA.

          Objective

          The aim was to determine whether wireless telemonitoring of CPAP compliance and efficacy data, compared to usual clinical care, results in higher CPAP compliance and improved OSA outcomes.

          Methods

          45 patients newly diagnosed with OSA were randomized to either telemonitored clinical care or usual clinical care and were followed for their first 2 months of treatment with CPAP therapy. CPAP therapists were not blinded to the participants’ treatment group.

          Results

          20 participants in each group received the designated intervention. Patients randomized to telemonitored clinical care used CPAP an average of 4.1 ± 1.8 hours per night, while the usual clinical care patients averaged 2.8 ± 2.2 hours per night ( P = .07). Telemonitored patients used CPAP on 78% ± 22% of the possible nights, while usual care patients used CPAP on 60% ± 32% of the nights ( P = .07). No statistically significant differences between the groups were found on measures of CPAP efficacy, including measures of mask leak and the Apnea-Hypopnea Index. Patients in the telemonitored group rated their likelihood to continue using CPAP significantly higher than the patients in the usual care group. Patients in both groups were highly satisfied with the care they received and rated themselves as “not concerned” that their CPAP data were being wirelessly monitored.

          Conclusions

          Telemonitoring of CPAP compliance and efficacy data and rapid use of those data by the clinical sleep team to guide the collaborative (ie, patient and provider) management of CPAP treatment is as effective as usual care in improving compliance rates and outcomes in new CPAP users. This study was designed as a pilot—larger, well-powered studies are necessary to fully evaluate the clinical and economic efficacy of telemonitoring for this population.

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          Most cited references36

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          Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale).

          We derived and tested a short form of the Center for Epidemiologic Studies Depression Scale (CES-D) for reliability and validity among a sample of well older adults in a large Health Maintenance Organization. The 10-item screening questionnaire, the CESD-10, showed good predictive accuracy when compared to the full-length 20-item version of the CES-D (kappa = .97, P or = 16 for the full-length questionnaire and > or = 10 for the 10-item version. We discuss other potential cutoff values. The CESD-10 showed an expected positive correlation with poorer health status scores (r = .37) and a strong negative correlation with positive affect (r = -.63). Retest correlations for the CESD-10 were comparable to those in other studies (r = .71). We administered the CESD-10 again after 12 months, and scores were stable with strong correlation of r = .59.
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            Reliability and factor analysis of the Epworth Sleepiness Scale.

            The Epworth Sleepiness Scale (ESS) is a self-administered eight-item questionnaire that has been proposed as a simple method for measuring daytime sleepiness in adults. This investigation was concerned with the reliability and internal consistency of the ESS. When 87 healthy medical students were tested and retested 5 months later, their paired ESS scores did not change significantly and were highly correlated (r = 0.82). By contrast, ESS scores that were initially high in 54 patients suffering from obstructive sleep apnea syndrome returned to more normal levels, as expected, after 3-9 months' treatment with nasal continuous positive airway pressure. The questionnaire had a high level of internal consistency as measured by Cronbach's alpha (0.88). Factor analysis of item scores showed that the ESS had only one factor for 104 medical students and for 150 patients with various sleep disorders. The ESS is a simple and reliable method for measuring persistent daytime sleepiness in adults.
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              Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study.

              Sleep-disordered breathing (SDB) and sleep apnea have been linked to hypertension in previous studies, but most of these studies used surrogate information to define SDB (eg, snoring) and were based on small clinic populations, or both. To assess the association between SDB and hypertension in a large cohort of middle-aged and older persons. Cross-sectional analyses of participants in the Sleep Heart Health Study, a community-based multicenter study conducted between November 1995 and January 1998. A total of 6132 subjects recruited from ongoing population-based studies (aged > or = 40 years; 52.8% female). Apnea-hypopnea index (AHI, the average number of apneas plus hypopneas per hour of sleep, with apnea defined as a cessation of airflow and hypopnea defined as a > or = 30% reduction in airflow or thoracoabdominal excursion both of which are accompanied by a > or = 4% drop in oxyhemoglobin saturation) [corrected], obtained by unattended home polysomnography. Other measures include arousal index; percentage of sleep time below 90% oxygen saturation; history of snoring; and presence of hypertension, defined as resting blood pressure of at least 140/90 mm Hg or use of antihypertensive medication. Mean systolic and diastolic blood pressure and prevalence of hypertension increased significantly with increasing SDB measures, although some of this association was explained by body mass index (BMI). After adjusting for demographics and anthropometric variables (including BMI, neck circumference, and waist-to-hip ratio), as well as for alcohol intake and smoking, the odds ratio for hypertension, comparing the highest category of AHI (> or = 30 per hour) with the lowest category ( or = 12% vs < 0.05%) was 1.46 (95% CI, 1.12-1.88; P for trend <.001). In stratified analyses, associations of hypertension with either measure of SDB were seen in both sexes, older and younger ages, all ethnic groups, and among normal-weight and overweight individuals. Weaker and nonsignificant associations were observed for the arousal index or self-reported history of habitual snoring. Our findings from the largest cross-sectional study to date indicate that SDB is associated with systemic hypertension in middle-aged and older individuals of different sexes and ethnic backgrounds.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                JMIR
                Journal of Medical Internet Research
                Gunther Eysenbach (Centre for Global eHealth Innovation, Toronto, Canada )
                1438-8871
                Apr-Jun 2007
                17 May 2007
                : 9
                : 2
                : e14
                Affiliations
                [3] 3simpleCalifornia Institute for Telecommunications and Information Technology (Calit2) simpleUniversity of California IrvineCAUSA
                [4] 4simpleVA Bedford Center for Health Quality, Outcomes & Economic Research simpleVA New England Healthcare BedfordMAUSA
                [5] 5simpleDepartment of Public Health and Medicine simpleBoston University BostonMAUSA
                [2] 2simpleDepartment of Psychiatry simpleUniversity of California San DiegoCAUSA
                [1] 1Health Services Research & Development ServiceVeterans Affairs San Diego Healthcare System (VASDHS)San DiegoCAUSA
                Article
                v9i2e14
                10.2196/jmir.9.2.e14
                1874716
                17513285
                7daf1158-50ea-4f8a-8e7f-12dfb3ec23c0
                © Carl J Stepnowsky Jr, Joe J Palau, Matthew R Marler, Allen L Gifford. Originally published in the Journal of Medical Internet Research (http://www.jmir.org, 17.05.2007). Except where otherwise noted, articles published in the Journal of Medical Internet Research are distributed under the terms of the Creative Commons Attribution License (http://www.creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited, including full bibliographic details and the URL (see "please cite as" above), and this statement is included.
                History
                : 13 October 2006
                : 03 November 2006
                : 26 April 2007
                : 08 May 2007
                Categories
                Original Paper

                Medicine
                continuous positive airway pressure therapy,cpap,sleep apnea syndromes,treatment compliance,telemedicine,randomized controlled trial

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