Introduction The effectiveness of continuous positive airway pressure (PAP) therapy is primarily measured by the reduction of the apnea-hypopnea index (AHI). A proxy measure of the sleep ...study-derived AHI can be obtained from the PAP device during the portion of the sleep period during which it is worn. Sleep quality and daytime functioning are considered two of the main outcomes desired by patients. Surprisingly few studies have examined the effectiveness of PAP therapy on sleep quality. Methods OSA participants (n = 695) from a combination of larger trials that examined a PAP adherence intervention were included. Participants were provided with PAP instruction and followed at 2 months. The Pittsburgh Sleep Quality Index (PSQI) was used as the primary measure of sleep quality. Results The PSQI total score was significantly correlated with PAP adherence at the 2-month time point, such that lower sleep quality was associated with lower PAP use. This finding held for the sleep disturbance subscale of the PSQI. The total PSQI score at baseline was 12.8±3.4 and at 2-month follow-up was 9.7±3.6, which is over the threshold of 5 for the PSQI total score and indicates poor sleep quality. Over 52% of those using PAP therapy at the 2-month time point reported significantly disturbed sleep, with the top three causes: 1) Wake up in the middle of the night or early morning (59%); 2) Have to get up to use the bathroom (56%); and 3) Have pain (33%). Conclusion This study shows that PAP therapy does not improve sleep quality to an acceptable degree. Over 50% patients using PAP therapy still experienced disturbed sleep. Whether the disturbed sleep is directly attributable to the PAP device itself or to disturbed sleep secondary to uncontrolled OSA when PAP is not worn requires further investigation. Clinical practice needs to focus on patient outcomes and not a single proxy measure of device effectiveness. Support (If Any) This project was supported in part by Department of Veteran Affairs and VA San Diego Healthcare System Research Service.
Obstructive Sleep Apnea (OSA) is exceedingly common but often under-treated. Continuous positive airway pressure (CPAP) has long been considered the gold standard of OSA therapy. Limitations to CPAP ...therapy include adherence and availability. The 2021 global CPAP shortage highlighted the need to tailor patient treatments beyond CPAP alone. Common CPAP alternative approaches include positional therapy, mandibular advancement devices, and upper airway surgery. Upper airway training consists of a variety of therapies, including exercise regimens, external neuromuscular electrical stimulation, and woodwind instruments. More invasive approaches include hypoglossal nerve stimulation devices. This review will focus on the approaches for modifying upper airway muscle behavior as a therapeutic modality in OSA.
Incomplete patient adherence with nasal continuous positive airway pressure (CPAP) limits the effectiveness of treatment and results in suboptimal obstructive sleep apnea (OSA) outcomes. An ...interactive website specifically designed for patients with OSA was designed and utilized in a randomized clinical trial to test its effect on increasing CPAP adherence. The goal of this paper is to report on CPAP adherence, internet use, privacy concerns and user satisfaction in using the website. The original project was designed as a randomized, controlled clinical trial of Usual Care (UC, control) versus MyCPAP group (intervention). Questionnaires were administered to evaluate the patient perspective of using the MyCPAP website. Participation in the MyCPAP intervention resulted in higher CPAP adherence at the two-month time point relative to participation in the UC group (3.4 ± 2.4 and 4.1 ± 2.3 hrs/nt; P=0.02; mean ± SD). Participants randomized to the MyCPAP website increased their use of the internet to obtain OSA related information, but did not increase their use of the internet to get information on general health or medical conditions. Users had very little concern about their CPAP data being viewed daily or being sent over the internet. Future studies should consider the use of newer evaluation criteria for collaborative adaptive interactive technologies.
Abstract
Introduction
The CPAP recall of 2021 has highlighted an inherent problem that occurs when a field of medicine is overly dependent on a single class of medical devices to treat a condition. ...The global shortage of CPAP devices has led to numerous individuals with OSA being unable to obtain a CPAP machine to treat their condition, including those with severe OSA. CPAP is well known to be efficacious in treating OSA, but has limited effectiveness, particularly for mild-to-moderate cases. It has been reported that there are nearly 200 different medical devices approved by the FDA to treat OSA. The goal of this project was to search the FDA databases to investigate the number of devices currently on file with the FDA. A secondary goal was to examine the range of FDA product categories for the treatment of OSA.
Methods
An FDA database (AccessGUDID; https://accessgudid.nlm.nih.gov) with a release date of December 1, 2021 was searched for devices that are approved for the treatment of sleep apnea. The text string “sleep apnea” was used for the search. Diagnostic devices, duplicate versions of the same treatment devices, and device accessories were excluded from the total counts. The FDA classifies medical devices into three categories (I, II, III), with a higher classification level indicating greater risk to patients.
Results
The FDA AccessGUDID database search returned 166 results, which resulted in 72 unique devices across 10 product code categories. 9 of the 10 product codes in the FDA database were class II (medium risk) and 1/10 was classified as III (high risk). 65 of the devices were reported to be in commercial distribution at the time of the search and 7 were not.
Conclusion
This analysis found that a relatively large number of FDA-approved devices exist for the treatment of OSA across a range of product categories. The field is encouraged to develop a better understanding of which subgroups of OSA patients could benefit from alternative forms of treatment in an effort to diversify treatment options and reduce the field’s reliance on a single type of device, particularly for patients with mild-to-moderate OSA.
Support (If Any)
VA IIR 16-277
Abstract Introduction Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population. The prevailing treatment for OSA is positive airway pressure (CPAP), but benefits depend on regular ...use. CPAP adherence is operationally defined as the number of hours of CPAP use per 24-hour period at the prescribed pressure. There are a variety of alternate metrics help to describe CPAP use, with most focused on duration and some type of categorization. Given the limited utility of these kinds of CPAP metrics, we wondered if a different type of CPAP adherence metric might be warranted. Putting on the CPAP mask is a behavioral action, so we explored the value of a metric focused on putting the mask on at least once per day. Methods Participants in an CPAP trial were provided standard education about their diagnosis and treatment at baseline. Follow-up visits were held two and four months from start of treatment. Treatment adherence metrics were derived from CPAP usage data. The “anyuse” metric was defined as the percentage of nights the mask was put on at least once in a 24-hour period. Results Twenty participants had a mean age of 50.2±13.9, mean AHI of 23.3±16.0, and mean BMI of 31.3.8±4.9 (kg/m2). Nightly CPAP adherence measured over the two-month period was 2.6±1.6 hours per night (mean±SD). The average anyuse at two-month was 78% ± 0.24 (12%-100%). Anyuse was moderately correlated with CPAP adherence (r=0.682, r-squared=0.465, p< 0.001), which means that while 46% of the variance in adherence was accounted for by anyuse, 54% of the variance was not. Conclusion The anyuse metric is a relatively simple metric that might have value as a supplemental metric to CPAP adherence. Importantly, it does not overlap substantially with CPAP adherence and provides a measure of initial behavioral action. A possible related metric is a count of the number of mask on events per day. Further exploration of these metrics appears to be warranted. Support (if any) This project was supported in part by the VA HSR&D IIR 16-277 and the VA San Diego Healthcare System Pulmonary Sleep Medicine Section and Research Service.
Abstract
Introduction
Research study recruitment has been profoundly affected by the COVID-19 pandemic, demonstrated by significant delays or pauses. Various guidelines pertaining to in-person visits ...have applied to research. Some call for exclusion of participants that the CDC has labeled “at increased risk”.1 For obstructive sleep apnea (OSA) studies, these guidelines have caused a sharp decrease in the number of new participants. This decrease is due to high rates of OSA comorbidities including obesity and diabetes. New evidence-based risk scores have been developed using individual- and community-level factors. The use of more refined COVID-19 risk scores can help protect patient safety while allowing research to continue.
Methods
The risk score assessment used for this study (COVID-19 Mortality Risk Calculator; Johns Hopkins University, Baltimore, MD)2 is evidence-based and uses a set of risk factors and community-level pandemic dynamics in the state of residence.3,4 It was compared to the list of CDC medical conditions that are considered to put an individual “at increased risk.” Both measures were calculated retrospectively on current participants to determine how many could safely attend in-person visits based on each risk assessment method.
Results
Sample characteristics of the 110 participants were: mean age: 49.5±13.7(24–76); mean BMI: 32.3±5.3(20.9–46.1); mean AHI: 24.3±21.4(5.1–110). Mortality Risk Calculator scores were: 91(82.7%) close to/lower than average Level 1; 12(10.9%) moderately elevated; 6(5.5%) substantially elevated; 1(0.9%) high; and 0(0%) very high Level 5. Using CDC guidance, 63 (57.3%) had at least one at-risk condition and 47 (42.7%) had 0. Using only Level 1 of the Risk Calculator would allow an additional 28 (25%) participants to attend in-person visits; using Levels 1 and 2 would allow an additional 40 (37%) participants.
Conclusion
Policies based on CDC at-risk conditions resulted in higher levels of participant exclusion in research during the COVID-19 pandemic than use of an evidence-based Mortality Risk Calculator. This analysis shows that researchers can use risk-adjusted scores to make informed decisions about study participation that balances both participant safety and research study progress.
Support (if any)
This project was supported in part by Department of Veteran Affairs VA HSRD IIR 16–277, VA RRD D2651-R, and VA San Diego Healthcare System Research Service.
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.
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.
El trabajo social, como disciplina que en sus prácticas afronta la problemática del embarazo adolescente en forma integral. El objetivo fue identificar el trabajo social y resiliencia frente casos de ...embarazo en adolescentes de la unidad educativa Picoaza, Ecuador. La investigación consideró el método científico, deductivo y analítico, nivel descriptivo con enfoque mixto, se utilizó como instrumento la guía de entrevista y la Escala de Resiliencia SV-RES de Eugenio Saavedra Guajardo y Marcos Villalta Paucar la cual se aplicó de manera online a la trabajadora social del Departamento de Consejería Estudiantil DECE y a estudiantes embarazadas. De acuerdo a los resultados, el 53 % de estudiantes se considera con valores, lo que permite identificar un adecuado estado de aceptación, mientras que con el 27 % un importante grupo se considera temeroso o débil, lo que puede dar pautas a posibles desajustes de comportamiento, con el 13 % indican ser valiente y tener fortaleza y con el 7 % se consideran optimista ante cualquier cambio en sus vidas. Por otro lado, las acciones que desarrolla la profesional en trabajo social de la unidad educativa, deben ser coordinadas con el equipo técnico profesional del departamento de bienestar estudiantil, quienes en conjunto desarrollen estrategias, que fomenten la autoestima.
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