Abstract
Introduction
Mild obstructive sleep apnea (OSA) is increasingly common in the VA. The first-line therapies are medical devices worn each night while asleep to control or manage OSA. These ...devices are burdensome for our patients with mild OSA. Stronger oral musculature can help reduce mild OSA. A new transoral Neuromuscular Electrical Stimulation (NMES) device was recently approved by the US FDA called eXciteOSA (Signifier Medical Technologies, Needham, MA). The eXciteOSA device provides gentle, low-frequency electrical stimulation intraorally to the tongue muscle and is efficacious for mild OSA.
Methods
A retrospective review of the data of the 71 patients prescribed the eXciteOSA device at the VA San Diego was analyzed. The device is prescribed for use over two phases: (1) one 20-minute session per day over 42 consecutive days and then (2) one 20-minute session on two days out of each week. Respiratory therapists performed 1-2 phone call visits to assess symptoms and address device concerns.
Results
68 of the 71 patients used the device for at least one 20-minute session over the first 42 days. Three patients (4.2%) did not use the device. Adherence was 60% for all 71 patients and 63% for the 68 patients who used it at least once. This means that, on average, our Veteran patients completed one 20-minute session on 25 of the first 42 days.
Conclusion
Recent non-Veteran data showed an adherence rate of ~80% (percentage of days with one completed 20-minute session over the first 42 days). Our analysis found an adherence rate of ~60%, suggesting significant room for improvement in eXciteOSA device use in Veterans. Future adherence studies should look at methods to improve device use over the first 42 days. In addition, more research may be needed to understand better what amount of use is efficacious on an individual basis. Some patients may obtain an adequate response with fewer sessions, while others may need more. It is unknown which endotypes of OSA most benefit from NMES, but further research is ongoing.
Support (if any)
VA RR&D D2651-R and the Sleep Medicine Section of the VA San Diego Healthcare System supported this project.
With the advent of ambulatory blood pressure monitoring has come the awareness that blood pressure (BP) normally drops, or "dips," at night by roughly 10%. A number of pathological conditions have ...been associated with the nondipping of nocturnal BP. In general, researchers have looked at dipping in neurological and cardiovascular disorders. We examined the extent to which nocturnal nondipping might be influenced by relatively gross measures of social environment.
This study examined 78 healthy adults and adults with mild hypertension who were not currently receiving medication, aged 25 to 52 years (mean age = 38.2). Forty-two participants self-identified as black and 36 identified as white.
Age, body mass index, apnea-hypopnea index, screening BP, ethnicity, and socioeconomic status (SES) were significantly associated with nocturnal BP dipping, accounting for 41% of the variance in dipping (F6,51 = 5.473, p <.001). When SES was entered on the last step of a hierarchical regression analysis, it independently accounted for 8% of the variance in dipping, even after accounting for ethnicity, such that the lower the SES, the more the nondipping.
It remains to be seen what aspect of the social environment may be driving this association between nondipping and lower social class. However, investigators might consider including social class in their models in future studies.
Obstructive sleep apnea (OSA) is a condition with serious medical and psychosocial consequences. However, poor adherence with nasal continuous positive airway pressure (CPAP) treatment limits the ...effectiveness of treatment. Behavior change factors offer one avenue of research to better understand the correlates of CPAP adherence.
Fifty-eight participants who had been diagnosed with OSA and prescribed CPAP treatment agreed to complete questionnaires that assessed sleep apnea symptoms, behavior change factors, and CPAP side effects, and to have their CPAP data downloaded. Behavior change factors from both social cognitive theory (SCT) and the transtheoretical model (TM) were assessed. The primary aim of the study was to examine the relationship between these social-cognitive factors and objectively measured CPAP adherence.
Participants had been using CPAP for a mean of 2.1 years. SCT variables (adjusted
R
2=0.115,
P=.008) and TM variables (adjusted
R
2=0.157,
P<.0001) each accounted for a statistically significant amount of variance in CPAP adherence.
The results suggest that social-cognitive factors may be associated with CPAP adherence in experienced CPAP users. The principal advantage to these theory-driven and empirically validated factors is that they are modifiable and can provide the basis for effective interventions to increase CPAP adherence.
Introduction Sleep apnea (OSA) is considered a syndrome because it results in the experience of different symptoms in different patients. Most instruments measure a single construct. However, because ...patients’ different symptom clusters, a different measurement approach is important to explore and the Sleep Apnea Quality of Life (SAQLI) Index offered this opportunity. Methods We had the opportunity to examine the SAQLI in a group of 348 diagnosed sleep apnea patients who were taking part in a larger CPAP adherence clinical trial.Patients had a mean age of 53.1±13.6, BMI of 32.6±5.7, and AHI of 30.3±18.9. All were given identical PAP instruction and follow-up at four-months. The SAQLI at baseline includes 14 multiple-choice items and a 21-item symptom checklist; at follow-up it includes an additional 26-item treatment symptom checklist. The checklists are comprised of 3 steps: (1)Check the boxes of all symptoms; (2)List up to the 5 most important symptoms; and (3)Rate each of those top symptoms. SAQLI scores are based on a range from 1(large problem) to 7(no problem). Results The SAQLI score improved from baseline to 4-month timepoint (4.1±1.4 to 5.1±1.4), but the sleep apnea symptoms score decreased (3.1±2.1 to 2.4±1.8). The treatment symptom score at follow-up was 2.1±1.7, indicating a large problem. 76% endorsed the 5 most important symptoms at baseline and 46% at follow-up. The most commonly endorsed symptoms at baseline were “Decreased energy” and “Waking up in the morning feeling unrefreshed and/or tired”. All 22 items were endorsed and write-in symptoms were included as well indicating the experience of a wide range of symptoms. Conclusion This study suggests that overall sleep apnea-related quality of life improves with CPAP therapy, but that there are number of sleep apnea symptoms and treatment symptoms still experienced by those who are using CPAP 4 months after starting therapy. The SAQLI functions as a patient-centered instrument because it can pick up individualized symptoms and issues that are still being experienced 4 months later. Support (If Any) This project was supported in part by Department of Veteran Affairs IIR 12-069.
Unreliability associated with scoring sleep variables is a potentially problematic issue in clinical and research studies. When scoring unreliability is unrecognized, it can contribute to the ...following: increase variability in the measures of interest, decrease a study's ability to detect important relationships, attenuate correlation coefficients, and increase clinical trial costs.
This paper first models the relationship between scoring variability and reliability in commonly studied sleep variables. The paper then models the relationship between unreliability and sample size requirements and statistical power. Standard methods are used to model reliability using the intraclass correlation coefficient.
The analysis shows that when scoring unreliability is minimized (i.e., scoring reliability is maximized), correlation coefficients are more robust, sample size requirements are reduced, statistical power is increased, and clinical trial costs are reduced.
When scoring unreliability is recognized, research studies can compensate by increasing the number of research subjects studied; however, it is at the cost of increasing the costs of research and exposing greater numbers of subjects to possible study risks. An effective solution is to implement rigorous initial and ongoing training efforts to maintain high inter-rater and intra-rater reliability coefficients.
Objective. Chronic hepatitis C infection afflicts millions of people worldwide. Although antiviral treatments are increasingly effective, many hepatitis C virus (HCV) patients avoid treatment, do not ...complete or respond to treatment, or have contraindications. Self-management interventions are one option for promoting behavioral changes leading to liver Wellness and improved quality of life. Our objective was to evaluate whether the effects of the HCV self-management program were sustained at the 12-month follow-up assessment. Methods. Veteran Affairs patients with hepatitis C (N = 134; mean age = 54.6 years, 95% male, 41% ethnic minority, 48% homeless in last 5 years) were randomized to either a 6-week self-management workshop or an information-only intervention. The weekly 2-hour self-management sessions were based on a cognitive-behavioral program with hepatitis C-specific modules. Outcomes including hepatitis C knowledge, depression, energy, and health-related quality of life were measured at baseline, 6 weeks, 6 months, and 12 months later. Data were analyzed using repeated measures ANOVA. Results. Compared with the information-only group, participants attending the self-management workshop improved more on HCV knowledge (p < .005), SF-36 energy/vitality (p = .016), and the Quality of Well-Being Scale (p = .036). Similar trends were found for SF-36 physical functioning and Center for Epidemiologie Studies Short Depression Scale. Conclusion. Better outcomes were sustained among self-management participants at the 12-month assessment despite the intervention only lasting 6 weeks. HCV health care providers should consider adding self-management interventions for patients with chronic HCV.
Obstructive sleep apnea (OSA) is a condition with serious medical and psychosocial consequences. Low patient adherence to nasal continuous positive airway pressure (CPAP) limits the effectiveness of ...treatment. Intervention studies based on intensive support protocols have shown modest improvement in CPAP adherence; however, this approach would require significant resources and effort for integration into the existing U.S. health care system. The purpose of this article is to describe the self-management approach to chronic illness, justify the self-management approach as applied to sleep apnea patients prescribed CPAP, and to report initial pilot data on feasibility and efficacy of the Sleep Apnea Self-Management Program. CPAP adherence measured at the end of the 4-session program averaged 5.5 ± 2.3 hr per night. The Sleep Apnea Self-Management Program (SASMP) has the potential to be an effective and practical way to improve CPAP adherence and is designed for integration into current OSA clinical processes.
Abstract
Introduction
The Veterans Health Administration (VA) is one of the largest integrated healthcare systems in the United States. Key risk factors for obstructive sleep apnea (OSA) include ...aging, weight, and male gender, all of which are highly prevalent in the VA population and help to explain the higher rates of OSA in the VA. The Pulmonary Sleep Program at the VA San Diego Healthcare System (VASDHS) started a patient database over twenty years ago for its home sleep apnea testing (HSAT) program. An analysis of ten years of diagnostic HSAT data was reported on over 12,500 patients in 2014. This analysis focuses on an update on the last four years and a comparison to 2014.
Methods
A retrospective review of the local clinical database of HSAT diagnostic testing was conducted. The database contained 8,928 sleep studies from 2018 to 2022. Invalid studies were removed. Only initial diagnostic studies were included.
Results
Of the 8,928 diagnostic studies, 2,564 tested negative for OSA (28.7%). Of the 6,364 positive cases, 43.3% were mild, 28.8% were moderate, and 27.9% were severe. The percentages of each OSA severity level were stable across these years (mild: 42%-45%; moderate: 27%-32%; and severe: 26%-29%). The mean AHI did not significantly change from 2018 (24.1+/-20.6) to 2022 (25.1+/-21.2) (overall mean 24.4+/-20.3; range: 5-140).
Conclusion
Based on this extensive retrospective review of diagnostic testing at a single, high-volume HSAT program, it appears that OSA severity levels have stabilized over these past five years, with the highest percentage of mild OSA cases (~43%) followed by moderate (~29%) and severe (~28%). Our facility saw a significant decrease in severe cases (60% to 30%) and increase in mild OSA (7% to 35%) from 2004 to 2013. Today, over 4 out of every 10 new OSA diagnoses are mild, which has significant treatment implications given that adherence to the two primary medical device options is suboptimal. Identifying patient-centered treatment options for these patients is a priority.
Support (if any)
VA RR&D D2651-R and the Sleep Medicine Section of the VA San Diego Healthcare System supported this project.
Few population-based studies have explored how excessive sleepiness (ES) contributes to burden of illness among patients with obstructive sleep apnea (OSA).
This study utilized data from the annual, ...cross-sectional 2016 US National Health and Wellness Survey. Respondents self-reporting an OSA diagnosis were categorized as having ES (Epworth Sleepiness Scale ESS score ≥ 11) or not having ES (ESS score < 11). Comorbidities, health-related quality of life (HRQoL), and productivity were examined in three groups: OSA with ES (n = 731), OSA without ES (n = 1,452), and non-OSA controls (n = 86,961).
The OSA with ES group had significantly higher proportions of respondents reporting depression (62.4% versus 48.0%), gastroesophageal reflux disease (39.0% versus 29.4%), asthma (26.3% versus 20.7%), and angina (7.8% versus 6.7%) compared to the OSA without ES group (
< .05). After controlling for covariates, the OSA with ES group had significantly lower (worse) scores for mental component score (41.81 versus 45.65 versus 47.81), physical component score (46.62 versus 48.68 versus 51.36), and SF-6D (0.65 versus 0.69 versus 0.73) compared with OSA without ES and non-OSA controls (all
< .001). The OSA with ES group had significantly higher (greater burden) mean rates of presenteeism (25.98% impairment versus 19.24% versus 14.75%), work impairment (29.41% versus 21.82% versus 16.85%), and activity impairment (31.09% versus 25.46% versus 19.93%) compared with OSA without ES and non-OSA controls (all
< .01) after controlling for covariates.
OSA with ES is associated with higher prevalence of comorbidities, reduced HRQoL, and greater impairment in productivity compared to OSA without ES and compared to non-OSA controls.
Excessive daytime sleepiness associated with obstructive sleep apnea affects 9%-22% of continuous positive airway pressure-treated patients. An indirect treatment comparison meta-analysis was ...performed to compare efficacy and safety of medications (solriamfetol, modafinil, and armodafinil) approved to treat excessive daytime sleepiness associated with obstructive sleep apnea.
Efficacy and safety measures assessed in this indirect treatment comparison included Epworth Sleepiness Scale (ESS), 20-minute Maintenance of Wakefulness Test (MWT20), Clinical Global Impression of Change (CGI-C), Functional Outcomes of Sleep Questionnaire (FOSQ), and incidence of treatment-emergent adverse events (any, serious, or leading to discontinuation).
A systematic literature review identified 6 parallel-arm, placebo-controlled randomized controlled trials that randomized 1,714 total participants to placebo, solriamfetol, modafinil, or armodafinil. In this indirect treatment comparison, all comparators were associated with greater improvements than placebo on the ESS, MWT20, and CGI-C after 4, 8, and 12 weeks of treatment. Relative to comparators and placebo at 12 weeks, solriamfetol at 150 mg or 300 mg had the highest probabilities of improvement in the ESS, MWT20, and CGI-C. Modafinil (200 or 400 mg) and solriamfetol (150 or 300 mg) were associated with greater improvement on the FOSQ than placebo at 12 weeks. Less than 2% of patients using placebo or comparators experienced serious or discontinuation-related treatment-emergent adverse events.
The results of this indirect treatment comparison show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with excessive daytime sleepiness associated with obstructive sleep apnea.
Ronnebaum S, Bron M, Patel D, et al. Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea.
. 2021;17(12):2543-2555.
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