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.
Background: Obstructive sleep apnea is a prevalent condition with serious medical and psychosocial consequences. Nasal continuous positive airway pressure (CPAP) is the treatment of choice and has ...been shown to reduce the frequency of nocturnal respiratory events, improve sleep architecture, and decrease daytime sleepiness. However, little is known about the dose–response relationship between CPAP compliance and measures of sleep apnea severity. This study examined the relationship between level of CPAP compliance and change in polysomnographic measures of sleep apnea severity.
Methods: Twenty-three CPAP-naive OSA patients were studied. None had other major medical illnesses or were receiving antihypertensive medication. Sleep apnea variables were measured at baseline and after 1 week of treatment. Objective CPAP compliance was measured nightly and was defined as the average number of hours of use per night.
Results: Higher rates of CPAP compliance were linearly associated with significant reductions in the respiratory disturbance index (
R=0.49,
P=0.017), the oxygen desaturation index (
R=0.48,
P=0.029), and the arousal index (
R=0.51,
P=0.016).
Conclusions: These data suggest that increased CPAP compliance is linearly associated with reductions in sleep apnea severity such that greater reductions in apnea were seen with increased CPAP use. It should be noted that all patients were reasonably compliant (i.e. >4
h CPAP use/night) and that even within this range of reasonable compliance, there was a significant benefit with more as opposed to less compliance. These findings offer support to the current recommendation that CPAP be used during the total time in bed to optimize treatment of polysomnographic measures of sleep apnea.
Abstract
Introduction
Obstructive sleep apnea (OSA) is a condition that is prevalent, pernicious, and linked to the development and exacerbation of several disease processes. Positive airway pressure ...(PAP) is a highly efficacious intervention; however, initiation and adherence rates are poor. This represents a critical gap in care and a missed opportunity to reduce morbidity and mortality associated with OSA. The present study piloted a single session of cognitive behavioral therapy for treatment seeking (CBT-TS) among veterans diagnosed with obstructive sleep apnea and newly prescribed PAP.
Methods
Participants were asked to complete assessments at baseline and at two- and four-weeks post-intervention. A sample of 40 Veterans were enrolled in the study and completed a baseline interview, 27 completed CBT-TS. A matched comparison group of 64 veterans who did not receive the intervention was constructed using electronic medical record and PAP adherence data. Mann Whitney U and Chi Square tests were used to examine group differences in initiation and adherence.
Results
Participants who completed the CBT-TS session were more likely to initiate PAP (at least 3 consecutive nights of use) as compared to those receiving treatment as usual (TAU) (CBT-TS; 96.3%; 26/27) versus (TAU; 64.1%; 41/64); X2(1, N = 91) = 10.16, p = .001. Participants in the CBT-TS group also used their PAP devices for a greater number of nights over the first month than the comparison group (CBT-TS; M = 21.7 (SD = 8.9), Mdn = 26.0) versus (TAU; M = 14.4 (SD = 12.6), Mdn = 15.5); U = 555.0, p = .007 and were more likely to use the device in an adherent manner (i.e., ≥4 hours use in an evening); (CBT-TS; M = 15.1 (SD = 11.2); Mdn = 15.0) versus (TAU; M = 10.3 (SD = 11.2), Mdn = 6.5); U =630.0, p = .038.
Conclusion
These preliminary data suggest that CBT-TS may have utility in increasing initiation of PAP and subsequent treatment adherence among Veterans diagnosed with OSA and newly prescribed PAP.
Support (if any)
This work was supported by the VA Center of Excellence for Suicide Prevention in the Finger Lakes Healthcare System.
Abstract Introduction Many patients with obstructive sleep apnea (OSA) discontinue positive airway pressure (PAP) over time. Insomnia symptoms frequently co-occur with OSA and are common in older ...adults. Comorbid insomnia and sleep apnea (COMISA) is associated with greater sleep disturbance, impaired daytime functioning, and worse quality of life vs OSA (or insomnia) alone. Whether COMISA vs OSA alone is associated with greater impairment in sleep quality and sleep-related function among older patients and no /limited PAP use is unknown. Methods Veterans with moderate or severe OSA (apnea-hypopnea index AHI >15) and no/limited objective current PAP use (prescribed >1 year ago) completed Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep (FOSQ-10) questionnaires. T-tests and age-adjusted regression analyses were used to compare participants who met DSM-5 diagnostic criteria for chronic insomnia disorder and sleep apnea (COMISA) vs OSA alone. Results In 128 veterans (Mage=64.6 years, 89% male, 19.5% Hispanic, 35.9% Black, 9.4% American Indian/Alaska Native, mean comorbidity index=5.5, BMI=32.2) with no/limited PAP use, COMISA (n=77, mean ISI=13.3) was associated with worse PSQI 7.8 vs 10.9, ESS 7.6 vs 9.6 and sleep-related function (FOSQ-10 15.6 vs 14.1) vs OSA alone (n=51, mean ISI=8.9) (all P<.05) despite no differences in AHI. Conclusion Among veterans with moderate-to-severe OSA and no/limited current PAP use, those with comorbid insomnia disorder (COMISA) have worse sleep quality, more daytime sleepiness and worse sleep-related function. These findings suggest that efforts to address insomnia disorder in addition to PAP use may be particularly important among older veterans with COMISA who do not use their prescribed PAP. Support (if any) VA, NIH/NHBLI
Abstract Introduction Retirement is a major life transition. Prior evidence suggests that retired individuals have better sleep quality than working individuals, though may also exhibit worse ...physical and mental health-related quality of life (HRQOL). Few studies have examined how retirement can impact the relationship between sleep and HRQOL, particularly among veterans who often face greater impairments in sleep and health. Methods Secondary analyses were conducted in a sample of 346 older veterans (mage=64, 47% white) with suspected co-morbid sleep apnea and insomnia. Measures included retirement status (retired/not retired), the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and Short-Form Health Survey (SF-12) encompassing both physical (SF-P) and mental health-related (SF-M) quality of life. Multiple regression analyses were conducted, with each model containing one sleep variable (ex. ISI), retirement status, and statistical interactions predicting SF-M or SF-P. Results All models were statistically significant. Retirement status was a significant predictor of SF-P across models (-4.52< b<-4.22, p≤.001), but was not a predictor of SF-M. When coupled with PSQI, the relationship between PSQI and SF-P was moderated by retirement status (b=-.68, p=.02), with retired individuals endorsing lower SF-P with poorer sleep quality compared to non-retired individuals. PSQI was also a significant predictor of SF-M (b=-1.27, p<.001). ISI was a significant predictor of both SF-P (b=-.41, p=.01) and SF-M (b=-.9, p<.001). Conclusion Poor sleep and being retired are associated with poor physical HRQOL, with physical HRQOL being particularly impacted by sleep quality in veterans who are retired. In contrast, only poor sleep functioning appeared to impact mental HRQOL. Findings from this study highlight the importance of sleep-related factors in maintaining HRQOL as well as the role retirement can play in physical HRQOL. Support (if any) Support: Support provided by the Veterans Administration (VA) HSR&D (Award #: HX003221), VA Greater Los Angeles GRECC, and the National Heart, Lung and Blood Institute (NHLBI)
Abstract
Study Objectives
Cognitive behavioral therapy for insomnia (CBTI) for comorbid insomnia and obstructive sleep apnea (OSA) has had mixed results. We integrated CBTI with a positive airway ...pressure (PAP) adherence program and tested effects on sleep and PAP use.
Methods
125 veterans (mean age 63.2, 96% men, 39% non-Hispanic white, 26% black/African American, 18% Hispanic/Latino) with comorbid insomnia and newly-diagnosed OSA (apnea-hypopnea index ≥ 15) were randomized to 5-weekly sessions integrating CBTI with a PAP adherence program provided by a “sleep coach” (with behavioral sleep medicine supervision), or 5-weekly sleep education control sessions. Participants and assessment staff were blinded to group assignment. Outcomes (baseline, 3 and 6 months) included Pittsburgh Sleep Quality Index (PSQI), 7-day sleep diary (sleep onset latency SOL-D, wake after sleep onset WASO-D, sleep efficiency SE-D), 7-day actigraphy (SE-A), and objective PAP use (hours/night and nights ≥ 4 h). Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) were also collected.
Results
Compared to controls, intervention participants showed greater improvement (baseline to 3 and 6 months, respectively) in PSQI (−3.2 and −1.7), SOL-D (−16.2 and −15.5 minutes), SE-D (10.5% and 8.5%), SE-A (4.4% and 2.6%) and more 90-day PAP use (1.3 and 0.9 more hours/night, 17.4 and 11.3 more nights PAP ≥ 4 h). 90-day PAP use at 3 months was 3.2 and 1.9 h/night in intervention versus controls. Intervention participants also had greater improvements in ISI, ESS, and FOSQ-10 (all p < 0.05).
Conclusions
An intervention integrating CBTI with a PAP adherence program delivered by a supervised sleep coach improved sleep and PAP use in adults with comorbid insomnia and OSA.
Trial Registration
ClinicalTrials.gov
Study name: Novel Treatment of Comorbid Insomnia and Sleep Apnea in Older Veterans
URL: https://clinicaltrials.gov/ct2/results?cond=&term=NCT02027558&cntry=&state=&city=&dist=
Registration: NCT02027558
Abstract
Introduction
Nonadherence to positive airway pressure (PAP) therapy is common in comorbid insomnia and obstructive sleep apnea (COMISA). We previously reported a novel behavioral treatment ...for COMISA which improves both PAP adherence and sleep. Our current goal was to assess whether improvements in PAP self-efficacy, knowledge, and decisional balance (targets of treatment) are associated with improvements in PAP use and sleep quality. We also collected participants’ perceptions of benefits and challenges of PAP during intervention.
Methods
125 veterans (96% men, 39% non-Hispanic white, 24% Black, 17% Hispanic/Latino) with COMISA were randomized to a 5-week intervention integrating behavioral insomnia therapy with a PAP adherence program versus general sleep education (control). Objective PAP use data and Pittsburgh Sleep Quality Index (PSQI) were collected over 6 months. Three behavior change subscales (PAP Self-Efficacy PAP-SE, Decisional Balance Index DBI, Knowledge KNOW) were administered at 6-months. Weekly self-report of participant-perceived benefits and challenges of PAP use were collected among intervention participants. Subscale scores, PAP use and PSQI were compared between intervention and control, and associations were tested. Change in mean number of benefits and challenges of PAP use were also tested (all analyses intent-to-treat).
Results
At 6-months, compared to controls, intervention participants had higher scores on all three subscales: PAP-SE (4.1 intervention versus 3.5 control, respectively), DBI (8.3, 0.9) and KNOW (10.5, 9.6, all p<.05). Intervention participants had more PAP use and lower (better) PSQI scores at 6-months (all p<.05). In the total sample, PAP use and PSQI correlated with PAP-SE (r=.52 PAP use, r=-.27 PSQI, respectively), DBI (r=.49, -.35) and KNOW (r=.43, -.21; all p<.05). Among intervention participants, perceived benefits of PAP increased over time (4.3 at week 2, 5.8 at week 4, respectively), and challenges decreased (3.7, 2.3; all p<.05).
Conclusion
Behavioral treatment for COMISA improves behavioral determinants of PAP use, which is associated with improvements in PAP use and sleep quality. In addition, with treatment, perceived benefits of PAP increase and challenges decrease. These findings suggest improvements in self-efficacy, knowledge and perceived benefits of PAP are important mechanisms through which behavioral interventions improve PAP use in older adults with COMISA.
Support (If Any)
VAHSRD (IIR12–353-Alessi, RCSA20-191-Martin) and NIH (NHLBI K24HL143055-Martin, NIA K23AG049955-Dzierzewski)
Introduction Understanding the patient voice and experience is an integral part of clinical care. The American Sleep Apnea Association organized and hosted a Patient-Focused Medical Product ...Development (PFMPD) meeting for the FDA in June 2018. The PFMPD meeting was the first of its kind, focused on medical products in addition to medications. Prior to the PFMPD, similar Patient-Focused Drug Development (PFDD) meetings were held by the FDA beginning in 2012 as a forum for patient communities about their experiences living with their respective conditions and the treatments they are using. Methods A national survey was conducted. It was comprised of 32-items that were a combination of multiple choice and open-text fields. Sections included diagnosis, symptoms, impact of sleep apnea on daily living, treatments and impact of treatments. The survey was developed as a “fit-for-purpose” instrument for use in conjunction with the FDA’s PFDD initiative and was therefore informed by the focus of past PFDD meeting surveys and related medical literature. It was tested and refined by project staff and in a group of patients. It took an average of 17 minutes to complete. The survey was widely publicized, sent to email lists and promoted within social media. All responses were anonymous. Results The survey was available for completion between April and August 2018 and attracted a total of 5,630 responses, 85% of whom were sleep apnea patients and 14% were family or friends of a patient. 57% of respondents were female and 85% were diagnosed by a physician. 34% of respondents on CPAP continued to report moderate to severe daytime symptoms. 53% identified potential long-term consequences of OSA on health and lifespan as their top concern. 70% reported using CPAP, and of those, 82% reported using it 7 nights per week and 6.2 hours per night. Conclusion The PFMPD survey conducted by the ASAA is a rich source of the sleep apnea patient’s experience encompassing recognition, diagnosis, symptoms, and treatment. Support (If Any) The FDA AWAKE meeting was hosted by the American Sleep Apnea Association.
Introduction This study sought to take advantage of technological and methodological advancements in the field of Mobile Health and apply them to a large-scale longitudinal research study on sleep ...and activity. Large-scale studies of sleep patterns, quality, and associated characteristics substantiated by objective data are lacking. Utilizing a novel platform, we sought to gain further insights into the relationship between sleep and activity while simultaneously speeding up the recruitment process and maximizing data completeness. Methods A subset of Achievement community members were invited to the study and assessed for eligibility. Eligible participants completed an electronic consent process and a series of baseline questionnaires. Participants were asked to connect a wearable device through the study dashboard, which allowed objective sleep and activity data to be collected. Participants could access the study platform from any computer or connected mobile device. After successful completion of the baseline questionnaires, participants were sent a daily single-item Sleepiness Checker activity (Karolinska Sleepiness Scale) for 7 consecutive days at baseline and every 3 months thereafter for 1 year. Results During a 5-day recruitment period, 1156 participants enrolled in the study. 98% of enrolled participants completed baseline questionnaires and 91% completed a baseline sleepiness checker activity. Mean days of sleepiness checker completed was 5.7±1.7 (1-7), with 51% of participants completing 7 consecutive days. 85% of participants provided sleep-specific wearable data, and 87% provided activity-specific wearable data. At baseline, wearable data indicated that participants slept an average of 302.8±98.1 minutes per night (63-576) and self-reported TST was 391.2±108 minutes. Participant retention at one year was 60%, with 40% of those participants completing 7/7 days of the sleepiness checker. Conclusion Conducting online, community-based longitudinal studies that include objective sleep and activity data is an innovative approach to expanding sleep research. As is the case with all large community-based studies, data quality and representativeness of the sample to the overall population must be carefully examined. Support (If Any) This study was supported in part by the American Sleep Apnea Association and Evidation Health.
Improved data transmission technologies have facilitated data collected from positive airway pressure (PAP) devices in the home environment. Although clinicians’ treatment decisions increasingly rely ...on autoscoring of respiratory events by the PAP device, few studies have specifically examined the accuracy of autoscored respiratory events in the home environment in ongoing PAP use. “PAP efficacy” studies were conducted in which participants wore PAP simultaneously with an Embletta sleep system (Embla, Inc., Broomfield, CO), which was directly connected to the ResMed AutoSet S8 (ResMed, Inc., San Diego, CA) via a specialized cable. Mean PAP-scored Apnea-Hypopnea Index (AHI) was 14.2 ± 11.8 (median: 11.7; range: 3.9–46.3) and mean manual-scored AHI was 9.4 ± 10.2 (median: 7.7; range: 1.2–39.3). Ratios between the mean indices were calculated. PAP-scored HI was 2.0 times higher than the manual-scored HI. PAP-scored AHI was 1.5 times higher than the manual-scored AHI, and PAP-scored AI was 1.04 of manual-scored AI. In this sample, PAP-scored HI was on average double the manual-scored HI. Given the importance of PAP efficacy data in tracking treatment progress, it is important to recognize the possible bias of PAP algorithms in overreporting hypopneas. The most likely cause of this discrepancy is the use of desaturations in manual hypopnea scoring.
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