Functional Outcomes Of Sleep Questionnaire Scores Research Articles

Telemedicine management of obstructive sleep apnea disorder in China: a randomized, controlled, non-inferiority trial.

Previous studies assessed different components of telemedicine management pathway for OSA instead of the whole pathway. This randomized, controlled, and non-inferiority trial aimed to assess whether telemedicine management is clinically inferior to in-person care in China. Adults suspected of OSA were randomized to telemedicine (web-based questionnaires, self-administered home sleep apnea test [HSAT], automatically adjusting positive airway pressure [APAP], and video-conference visits) or in-person management (paper questionnaires, in-person HSAT set-up, APAP, and face-to-face visits). Participants with an apnea-hypopnea index (AHI) ≥ 15 events/hour received APAP for 3months. The non-inferiority analysis was based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score and APAP adherence. Cost-effectiveness analysis was performed. In the modified intent-to-treat analysis set (n = 111 telemedicine, 111 in-person), FOSQ scores improved 1.73 (95% confidence interval [CI], 1.31-2.14) points with telemedicine and 2.05 (1.64-2.46) points with in-person care. The lower bound of the one-sided 95% non-inferiority CI for the difference in change between groups of - 0.812 was larger than the non-inferiority threshold of - 1. APAP adherence at 3months was 243.3 (223.1-263.5) minutes/night for telemedicine and 241.6 (221.3-261.8) minutes/night for in-person care. The lower bound of the one-sided 95% non-inferiority CI of - 22.2min/night was higher than the non-inferiority delta of - 45min/night. Telemedicine had lower total costs than in-person management (CNY 1482.7 ± 377.2 vs. 1912.6 ± 681.3; p < 0.0001), driven by patient costs, but no significant difference in QALYs. Functional outcomes and adherence were not clinically inferior in patients managed by a comprehensive telemedicine approach compared to those receiving in-person care in China. https://www.chictr.org.cn , Registration number ChiCTR2000030546. Retrospectively registered on March 06, 2020.

Subjective Efficiency Evaluation after Maxillomandibular Advancement Surgery in Obstructive Sleep Apnea Patients.

To investigate subjective efficiency outcomes after maxillomandibular advancement (MMA) surgery in obstructive sleep apnea (OSA) patients. A prospective cohort study was carried out between December 2016 and May 2021, including 30 severe or treatment-refractory OSA patients treated by MMA surgery. All patients answered four validated questionnaires: the Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Mandibular Function Impairment Questionnaire (MFIQ), and EQ-5D-3L (i.e., EQ-5D and EQ-VAS). They also answered one custom-made questionnaire (AMCSQ). Questionnaires were requested to be filled out 1 week before surgery and at least 6 months after surgery. The total preoperative and postoperative scores on the questionnaires were compared. The mean total ESS (p < 0.01), FOSQ (p < 0.01), EQ-5D (p < 0.05), and EQ-VAS (p < 0.01) scores showed significant improvement, which was in accordance with an improvement in the mean postoperative apnea/hypopnea index score (p < 0.01). In contrast, the mean total MFIQ score (p < 0.01) indicated a decline in mandibular function. This study confirms the hypothesis that MMA surgery in OSA patients improves outcomes, both objectively and subjectively, with the exception of postoperative mandibular function.

0448 Telemedicine Management of Obstructive Sleep Apnea Disorder: A Randomized Controlled Trial

Abstract Introduction Previous studies assessed different components of telemedicine instead of the whole telemedicine management pathway for OSA. The current study aimed to demonstrate that telemedicine management was not clinically inferior to in-person care in China based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score following three months of an auto-adjusted positive airway pressure (APAP) treatment. Methods Adults suspected of OSA were randomized to telemedicine (n=178) or in-person (n=178) management. Participants with AHI ≥ 15 events/hour diagnosed by a home sleep apnea test (HSAT) were treated with an APAP with a wireless modem. The participants were followed up by call at week 1 and visit at month 1 and month 3. Results We measured the change in FOSQ score as the primary outcome, with an a priori noninferiority delta of -1, and the mean daily hours of objectively measured APAP adherence, with an a priori noninferiority delta of -45min/day. Of the 356 subjects enrolled, 313 (87.9%) were diagnosed with OSA, and 261 (73.3%) underwent PAP setup. The mean functional outcome score following 3 months improved 1.73 points (95%CI: 1.31, 2.14) in the telemedicine group and 2.05 points (95% CI: 1.64, 2.46) in the in-person group. The lower bound of the one-sided 95% noninferiority confidence interval was -0.812. Mean daily APAP adherence at 3 months was 243.3 minutes/night (95% CI: 223.1, 263.5) in the telemedicine arm and 241.6 minutes/night (95% CI: 221.3, 261.8) in the in-person arm. The lower bound of the one-sided 95% noninferiority confidence interval was -22.2 minutes/night. Compared to in-person management, the telemedicine pathway had lower patients cost and similar health care cost. Conclusion Functional outcome and treatment adherence in patients managed by a comprehensive telemedicine approach is not clinically inferior to that in patients receiving in-person care. Support (if any) ResMed Australia funded the APAP machines. The study was supported by the National Key R&amp;D Program of China (Z161100002616012). Liyue Xu is supported by a grant from the National Natural Science Foundation of China (NSFC 82100104).

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV): protocol and cohort profile.

Although adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL). This report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up. The registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea--hypopnoea index was 48±23 events·h-1 (≥30 events·h-1 in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10). The most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.

Pulmonary rehabilitation: A novel adjunct in management of obstructive sleep apnea.

Pulmonary rehabilitation (PR) is being used in the routine management of patients of obstructive sleep apnea (OSA) at some centers. However, the studies documenting benefits of PR in OSA lack standardization in terms of outcome measures. A study was hence planned to determine the efficacy of PR on exercise capacity, health related quality of life (HRQOL), day time sleepiness and sleep-quality of life (QOL) in patients of OSA. As a part of comprehensive therapy, patients diagnosed with OSA are managed with continuous positive airway pressure (CPAP), 8 weeks thrice weekly outpatient hospital-based PR and medical treatment at the Pulmonary Medicine Department, Government Medical College and Hospital, Chandigarh. However, some patients refuse for PR because of time constraints and travel issues. Patients with newly diagnosed OSA without co-existing respiratory disease, who agreed for the CPAP, PR and medical management were enrolled in group A. The patients who refused for PR but were ready for CPAP and medical management were enrolled in Group B; 30 patients were taken in each group. Exercise capacity, HRQOL, day time sleepiness and sleep-QOL were determined at baseline and at 8-weeks follow-up by 6-minute walk distance (6MWD), St. George's Respiratory Questionnaire (SGRQ), Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) and compared amongst the two groups. Four patients from group A were excluded as they did not complete PR; 26 patients from group A and 30 patients from group B were finally analyzed. At baseline, both groups were matched with respect to age, gender, apnea-hypopnea index (AHI), body mass index (BMI), FEV1%predicted, 6MWD, SGRQ, ESS and FOSQ. At follow up at 8 weeks, BMI, 6MWD, SGRQ, ESS and FOSQ improved significantly from baseline in group A (p<0.001). FEV1%predicted also improved but non significantly. In group B, FEV1%predicted, BMI, 6MWD, SGRQ, ESS and FOSQ score did not improve significantly from baseline. Mean improvement from baseline in BMI, 6MWD, SGRQ, ESS and FOSQ was significantly more in group A than group B (p<0.001, p<0.001, p=0.041, p<0.001 and p<0.001, respectively). PR, being beneficial, should be incorporated in standard management of OSA.

Insomnia affects patient-reported outcome in sleep apnea treated with hypoglossal nerve stimulation.

ObjectiveComorbid insomnia may impact outcomes of patients with obstructive sleep apnea (OSA) receiving hypoglossal nerve stimulation with respiratory sensing (HNS) therapy. To examine whether the presence of insomnia measured using the Insomnia Severity Index (ISI) is associated with patient‐reported outcomes and objective OSA measures in patients receiving HNS therapy.MethodsIn this retrospective chart review, patients with an HNS implant and ISI score at follow‐up assessment were categorized as having moderate/severe insomnia or no/subthreshold insomnia. OSA‐related data (Apnea Hypopnea Index, AHI; Oxygen Desaturation Index, ODI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and overall patient satisfaction was compared between these patient categories. Correlations between ISI scores and each of these variables were examined.ResultsOf the 132 patients, 26% had moderate/severe insomnia at follow‐up assessment. ESS and FOSQ scores were worse in the insomnia group at baseline, follow‐up, and in the change from baseline, but AHI and ODI scores did not differ between patients with and without insomnia. Frequency of overall satisfaction at follow‐up was lower in the insomnia group (58.8% vs. 92.8% with no insomnia, P < .001). Patients with insomnia were more likely to have depression (56% vs. 27% without insomnia, P < .002).ConclusionsInsomnia is associated with worse patient‐reported outcomes of daytime sleepiness and sleep‐related quality of life in patients with OSA receiving HNS therapy. Depression is more prevalent in patients with comorbid insomnia. The ISI may help physicians to address comorbid insomnia and achieve high patient satisfaction and adherence to HNS therapy.Level of Evidence4

Effectiveness of Surgical Mandibular Advancement in Improving Airway Dimensions in Nongrowing Skeletal Class II Patients With Obstructive Sleep Apnea—A CBCT Study

Background: Skeletal nongrowing class II patients with retrognathic mandible are often at risk of developing obstructive sleep apnea (OSA). This skeletal discrepancy, when severe enough, is often addressed by surgical mandibular advancement which not only achieves aesthetics, structural balance, and functional efficiency but also improves the airway function. Objective: The aim of the study was to evaluate the effectiveness of surgical mandibular advancement on airway dimensions, in nongrowing skeletal class II patients with mandibular retrognathism associated with OSA. Materials and Methods: The sample consisted of 8 patients with skeletal class II due to retrognathic mandible associated with OSA. Screening was done with functional outcomes of sleep questionnaire (FOSQ) score and confirmed with polysomnography. Pretreatment and posttreatment airway dimensions/volume were assessed and calculated on cone beam computed tomography (CBCT). Three months post surgery, oxygen saturation was recorded. Results: A statistically significant improvement in mean oxygen saturation level was observed from 87.62 ± 7.70 to 97.75 ± 0.46 and mean increase in airway volume was from 48.60 ± 7.17 to 69.48 ± 26.22. The smallest cross section increased from 137 ± 74.37 to 253.75 ± 76.67. Anteroposterior dimensions increased significantly from 6.17 ± 1.78 to 9.33 ± 2.07 and transversed from 24.56 ± 6.41 to 30.14 ± 3.35. FOSQ score improved from 9.37 ± 2.61 to 15.25 ± 0.88. Conclusion: Surgical mandibular advancement is an effective treatment option in improving airway dimensions in nongrowing skeletal class II patients with mandibular retrognathism associated with OSA.

Association of Hypoglossal Nerve Stimulation With Improvements in Long-term, Patient-Reported Outcomes and Comparison With Positive Airway Pressure for Patients With Obstructive Sleep Apnea

Hypoglossal nerve stimulation (HNS) and positive airway pressure (PAP) have been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA). However, to our knowledge, there are no data that compare change in PROs between HNS and PAP or that indicate whether HNS improves comorbid insomnia or depression in the long term. To determine whether HNS is associated with improvements in patient-reported sleepiness, insomnia, and depression in the long term and to compare the respective associations of HNS and PAP with improved PROs. This retrospective cohort study used data from patients treated at the Cleveland Clinic for OSA. Participants received either HNS (referred sample) from November 1, 2015, to September 31, 2018, or PAP (previous cohort) from January 1, 2010, to December 31, 2014, for OSA. Patients were matched 3:1 for PAP:HNS based on age, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), sex, and apnea hypopnea index (AHI). Data were collected at baseline and at prespecified follow-up points. Data were analyzed from March 26, 2020, to September 9, 2021. Treatment with HNS vs PAP. Data collected included AHI and Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Insomnia Severity Index (ISI), and Patient Health Questionnaire-9 (PHQ-9; depression) scores. Among 85 patients receiving HNS (mean [SD] age, 62.8 [9.5] years; 59 men [69.4%]; 77 White patients [90.6%]; mean [SD] BMI, 28.8 [3.1]), compared with 217 matched patients receiving PAP (mean [SD] age, 62.1 [9.9] years; 157 men [72.4%]; 173 White patients [81.2%]; mean [SD] BMI, 29.5 [3.1]) included in the analysis, significant improvements were seen in PHQ-9 scores for HNS vs PAP (least square means, -4.06 [95% CI, -5.34 to -2.79] vs -2.58 [95% CI, -3.35 to -1.82]; mean difference, -1.48 [95% CI, -2.78 to -0.19]) with comparable improvements in ESS, FOSQ, and ISI scores. Clinically meaningful differences were observed in 42 of 65 HNS group patients (64.6%) vs 118 PAP group patients (54.5%) for ESS scores, 29 of 49 HNS group patients (59.2%) vs 67 of 217 PAP group patients (30.9%) for FOSQ scores, 14 of 48 HNS group patients (29.2%) vs 53 of 217 PAP group patients (24.4%) for PHQ-9 scores, and 23 of 49 HNS group patients (46.9%) vs 79 of 217 PAP group patients (36.4%) for ISI scores. At the 1-year post-HNS assessment, meaningful improvements were seen in 17 of 28 patients (60.7%) for ESS scores, 11 of 20 patients (55.0%) for FOSQ scores, 7 of 23 patients (30.4%) for PHQ-9 scores, and 11 of 25 patients (44.0%) for ISI scores. In this cohort study of patients with OSA, sustained improvements in PROs were observed 1 year after HNS and were comparable to those for PAP at 3 months. These findings suggest that HNS is a viable treatment for improving insomnia and depression in patients with OSA.

1077 The Association Between Sleep Problems And Risk-taking Behavior Differs Between Racial Majority And Minority Groups

Abstract Introduction Individuals with Post-Traumatic Stress Disorder (PTSD) often experience poor sleep quality and elevated self-destructive behaviors. Among healthy individuals, poor sleep quality can lead to increased risk-taking behavior through decreased inhibition and/or increased willingness to take risks. However, it is unclear whether racial/ethnic background may influence this relationship, in particular among individuals with PTSD. We examined whether the relationship between sleep quality and risk propensity would differ between majority and minority racial groups in individuals with PTSD. Methods Seventy-six individuals (61.8% female; mean age=31.7, SD=8.8) with a clinical diagnosis of PTSD were administered the Functional Outcomes of Sleep Questionnaire (FOSQ) as a measure of sleep-related functional impairment of daily activities, and the Evaluation of Risk (EVAR) Scale as a measure of risk-taking propensity. Forty-seven individuals identified with the majority racial group (Caucasian) and 29 individuals identified themselves within the minority. Results There were no significant group differences for FOSQ and total EVAR risk-taking scores. However, the strength of association between measures differed significantly between groups (Z=1.95, p=.051). For the racial/ethnic majority, functional impairments due to lack of sleep were positively associated with risk-taking propensity (r=.460, p=.001); this relationship was not present for the minority group (r=.016, p=.936). Conclusion Self-reported functional impairments due to sleep loss significantly correlated with risk-taking propensity for those who identified themselves as part of the majority racial group but not for individuals who identified as part of a racial minority. Findings suggest that broad conclusions regarding the association between sleep disruption and risk-taking may not apply equally across racial/ethnic groups and such factors should be considered when evaluating studies of sleep and risk behaviors. Whether these differing effects are due to cultural factors or stable differences in biology is not known and will require additional research. Support W81XWH-14-1-0570

0655 CBT-I and CPAP in Comorbid Insomnia and Sleep Apnea: Effects on Daytime Functioning

Abstract Introduction This study examines the effects of treatment sequences using cognitive-behavioral therapy for insomnia (CBT-I) and continuous positive airway pressure (CPAP) therapy on daytime functioning in people with comorbid insomnia and sleep apnea (COMISA). Methods 118 participants with COMISA (Age=49.99±13.12; 53.4% female) were randomized to one of the three study arms: Arm A- CBT-I followed by CPAP, Arm B- CBT-I concurrent with CPAP, and Arm C- CPAP only. Participants were assessed at four time points [baseline/ start of phase 1 (A1), CPAP titration/ start of phase 2 (A2), 30 days (A3) and 90 days (A4) after CPAP initiation]. This study examined secondary outcome measures of daytime functioning, including the Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale, and Flinders Fatigue Scale (FFS). Results Linear mixed model analyses showed a main effect of time on improving functional outcomes in all measurements, with all p&amp;lt; 0.001. There were also arm by time interactions on FOSQ [F(6, 105.36)=4.21, p=0.001] and FFS scores [F(6, 106.95)=3.10, p=0.008]. Pairwise comparisons with Bonferroni adjustment showed improved FOSQ scores in Arm A from A1 to A2 (p=0.011) and A2 to A3 (p=0.005), Arm B from A2 to A3 (p&amp;lt; 0.001), and Arm C from A2 to A3 (p=0.006). For FFS scores, improvements were shown in Arm A from A1 to A2 (p=0.003), and Arm B from A2 to A3 (p &amp;lt; 0.001). Conclusion The results show daytime functioning improvements in patients with COMISA following CPAP and CBT-I. In addition, CBT-I appears to facilitate improvement in sleepiness-related functional status and daytime fatigue. The findings suggest that the combination of CBT-I and CPAP may have a beneficial effect on daytime functioning in patients with COMISA. Support This study was supported by the National Institutes of Health (R01HL114529).

Improvements in quality of life in female obstructive sleep apnea patients using a gender specific positive airway pressure device

Study Objectives: Females with obstructive sleep apnea (OSA) have more flow limitation, lower apnea-hypopnea index (AHI), shorter apneas, and less severe oxygen desaturations than males. A female-specific auto-adjusting continuous positive airway pressure (fAPAP) algorithm has been developed to target these characteristics. This study investigated the effects of fAPAP therapy on quality of life (QoL) in women with OSA. Methods: Female patients with AHI ≥ 15/h were eligible. Participants underwent polygraphy or polysomnography. The primary endpoint was change from baseline in Functional Outcomes of Sleep Questionnaire (FOSQ) score after 3 months’ fAPAP (AutoSet for Her, ResMed). Secondary endpoints included other sleep-related and QoL questionnaires. Results: A total of 122 patients were enrolled in the study (age 53.7 ± 9.5 years, body mass index 32.8 ± 6.2 kg/m2, apnea-hypopnea index [AHI] 39.0 ± 18.2/h); 111/122 completed the study. There was a significant improvement (p<0.0001) in FOSQ score from baseline (15.0 ± 3.3) to 3 months (16.9 ± 3.2). Significant improvements were also seen in the Patient Health Questionnaire-9 score (12.3 ± 6.0 vs. 7.2 ± 5.4), Epworth Sleepiness Scale score (10.8 ± 4.9 vs. 7.3 ± 4.7), EuroQol (EQ)-5D Index score (0.636 ± 0.248 vs. 0.763 ± 0.210), EQ-5D visual analogue scale score (54.4 ± 21.7 vs. 64.5 ± 21.5) (all p<0.0001), and Changes in Sexual Functioning Questionnaire score (38.7 ± 9.5 vs. 42.4 ± 8.5; p=0.001). In patients with PSG data, fAPAP improved other respiratory parameters (AHI, oxygen desaturation index, oxygen saturation; all p<0.0001), and increased time spent in rapid eye movement (REM) sleep (39.7 ± 24.0 vs. 48.1 ± 24.5 min; p=0.022). Average daily fAPAP usage was 4.8 ± 2.0 h/night. Conclusion: Usage of fAPAP significantly improved QoL and increased REM sleep, with good treatment compliance.

Obstructive sleep apnea and self-reported functional impairment in revascularized patients with coronary artery disease in the RICCADSA trial.

Daytime sleepiness, a frequent symptom of obstructive sleep apnea (OSA), can impact functional status. In patients with coronary artery disease (CAD) and concomitant OSA, the distinction between sleep-related functional impairment from underlying CAD versus OSA is unclear. This study evaluated the impact of OSA on sleep-related functional impairment in patients with CAD and compared the effect of 1-year continuous positive airway pressure (CPAP) use on change in impairment between those with and without excessive daytime sleepiness (EDS) and OSA. We hypothesized that sleep-related functional impairment is impacted by EDS independent of OSA in patients with CAD. One hundred five CAD patients without OSA and 105 with moderate-to-severe OSA from the RICCADSA trial were matched on disease severity and included in the current substudy. Of those with OSA, 80 were allocated to CPAP. Functional Outcomes of Sleep Questionnaire (FOSQ) score < 17.9 corresponded to sleep-related functional impairment. Following revascularization, CAD patients with and without OSA frequently report sleep-related functional impairment (35% and 27.3%, respectively; p = .29). Moderate-to-severe OSA was not related to baseline FOSQ scores < 17.9 in regression analyses; EDS was (OR 4.82, 95% CI 2.12-11.0; p < .001). CPAP use significantly improved FOSQ scores from baseline to 1-year follow-up in OSA patients with EDS (17.2 ± 2.0 to 18.15 ± 1.7, p = .002) despite suboptimal adherence. Sleep-related functional impairment may be reflective of persistent EDS, independent of OSA. Diagnosing OSA and initiating treatment are worthwhile in individuals with CAD and EDS, as both are important to guide appropriate therapy in patients with CAD.

Patient-Reported Outcomes in Older Adults With Obstructive Sleep Apnea Treated With Continuous Positive Airway Pressure Therapy.

Although continuous positive airway pressure (CPAP) therapy is regarded as the gold standard treatment for obstructive sleep apnea (OSA) in adults, outcomes in older patients are limited. This study examines the effect of CPAP therapy in older adults with OSA (older than 60 years) compared to younger adults (age 18 to 60 years) to inform the current standard of practice. We performed a retrospective study with a convenience sample to compare responses to CPAP treatment in older versus younger adults with OSA using validated, patient-reported outcomes (PROs). A total of 532 patients were analyzed at baseline and at 3, 6, and 12 months after CPAP initiation. The effects of CPAP adherence and OSA severity on PRO scores were measured in each age group. Patients older than 60 years had higher apnea-hypopnea indices but lower Epworth Sleepiness Scale (ESS), Fatigue Severity Scale (FSS), and Patient Health Questionnaire-9 (PHQ-9) scores and higher Functional Outcomes of Sleep Questionnaire (FOSQ) scores at baseline compared to patients age 18 to 60 years. At 1 year after CPAP initiation, significant and comparable improvements in ESS, FSS, PHQ-9, and FOSQ scores were observed in patients older than 60 years relative to younger patients. When stratifying by OSA severity, change between age groups was significantly different only for PHQ-9 in patients with mild OSA, with greater improvements observed in younger patients. This study adds to the limited data on treatment outcomes with CPAP therapy in older adults with OSA. Patients older than 60 years achieve improvement in sleepiness, fatigue, depressive symptoms, and quality of life analogous to that of younger adults.

Adjustable thermoplastic oral appliance versus positive airway pressure for obstructive sleep apnea.

To compare outcomes of continuous positive airway pressure (CPAP) and the adjustable thermoplastic mandibular advancement splint (AT-MAS) for obstructive sleep apnea treatment. Randomized crossover, noninferiority, tertiary center setting. Fifty patients with a mean age of 49.5 ± 10.6 years were enrolled. Inclusion criteria were age ≥18 years, apnea-hypopnea index (AHI) ≥5 events/hour, and oxygen saturation ≥70%. Exclusion criteria were temporomandibular joint disorders, severe periodontitis, inadequate teeth, and unstable medical diseases. Treatment intolerance was considered a failure. Two-week periods without treatment were followed by questionnaires and randomization into two groups: CPAP/AT-MAS (25) and AT-MAS/CPAP (25). After 6 weeks of intervention, questionnaires and home WatchPAT monitoring were performed. Following each 2-week washout period, patients crossed over to the other treatment followed by similar procedures. Primary outcomes involved the scores from the Functional Outcomes of Sleep Questionnaire (FOSQ). Secondary outcomes were AHI, side effects, and treatment adherence. Seven patients withdrew from this study: five (AT-MAS intolerance) and two (lost follow-up). There was no significant difference among FOSQ scores, particularly on global scores, between both treatments (0.57, 95% confidential interval of difference: -0.15 to 1.29). Mean AHI decreased from pretreatment 39.2 ± 2.53 to 2.56 ± 0.49 and 12.92 ± 2.05 events/hour while using CPAP and the AT-MAS, respectively (P < .05). Most common side effects of CPAP were dry throat and inconvenience to carry, whereas those of the AT-MAS were jaw pain and excessive salivation. Both devices improved short-term quality of life similarly; however, the AT-MAS was not as efficacious as CPAP on resolving sleep-test parameters. The AT-MAS might be considered only a temporary treatment alternative. 1b. Laryngoscope, 128:516-522, 2018.

Physician Decision Making and Clinical Outcomes With Laboratory Polysomnography or Limited-Channel Sleep Studies for Obstructive Sleep Apnea: A Randomized Trial.

The clinical utility of limited-channel sleep studies (which are increasingly conducted at home) versus laboratory polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) is unclear. To compare patient outcomes after PSG versus limited-channel studies. Multicenter, randomized, noninferiority study. (Australian New Zealand Clinical Trials Registry: ACTRN12611000926932). 7 academic sleep centers. Patients (n= 406) aged 25 to 80 years with suspected OSA. Sleep study information disclosed to sleep physicians comprised level 1 (L1) PSG data (n= 135); level 3 (L3), which included airflow, thoracoabdominal bands, body position, electrocardiography, and oxygen saturation (n= 136); or level 4 (L4), which included oxygen saturation and heart rate (n= 135). The primary outcome was change in Functional Outcomes of Sleep Questionnaire (FOSQ) score at 4 months. Secondary outcomes included the Epworth Sleepiness Scale (ESS), the Sleep Apnea Symptoms Questionnaire (SASQ), continuous positive airway pressure (CPAP) compliance, and physician decision making. Change in FOSQ score was not inferior for L3 (mean difference [MD], 0.01 [95% CI, -0.47 to 0.49; P= 0.96]) or L4 (MD, -0.46 [CI, -0.94 to 0.02; P= 0.058]) versus L1 (noninferiority margin [NIM], -1.0). Compared with L1, change in ESS score was not inferior for L3 (MD, 0.08 [CI, -0.98 to 1.13; P= 0.89]) but was inconclusive for L4 (MD, 1.30 [CI, 0.26 to 2.35; P= 0.015]) (NIM, 2.0). For L4 versus L1, there was less improvement in SASQ score (-17.8 vs. -24.7; P= 0.018), less CPAP use (4.5 vs. 5.3 hours per night; P= 0.04), and lower physician diagnostic confidence (P= 0.003). Limited-channel studies were simulated by extracting laboratory PSG data and were not done in the home. The results support manually scored L3 testing in routine practice. Poorer outcomes with L4 testing may relate, in part, to reduced physician confidence. National Health and Medical Research Council and Repat Foundation.

Upper Airway Stimulation for Obstructive Sleep Apnea: Self-Reported Outcomes at 24 Months.

To evaluate the long-term (24-mo) effect of cranial nerve upper airway stimulation (UAS) therapy on patient-centered obstructive sleep apnea (OSA) outcome measures. Prospective, multicenter, cohort study of 126 patients with moderate to severe OSA who had difficulty adhering to positive pressure therapy and received the surgically implanted UAS system. Outcomes were measured at baseline and postoperatively at 12 mo and 24 mo, and included self- and bedpartner-report of snoring intensity, Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ). Additional analysis included FOSQ subscales, FOSQ-10, and treatment effect size. Significant improvement in mean FOSQ score was observed from baseline (14.3) to 12 mo (17.3), and the effect was maintained at 24 mo (17.2). Similar improvements and maintenance of effect were seen with all FOSQ subscales and FOSQ-10. Subjective daytime sleepiness, as measured by mean ESS, improved significantly from baseline (11.6) to 12 mo (7.0) and 24 mo (7.1). Self-reported snoring severity showed increased percentage of "no" or "soft" snoring from 22% at baseline to 88% at 12 mo and 91% at 24 mo. UAS demonstrated large effect size (> 0.8) at 12 and 24 mo for overall ESS and FOSQ measures, and the effect size compared favorably to previously published effect size with other sleep apnea treatments. In a selected group of patients with moderate to severe OSA and body mass index ≤ 32 kg/m2, hypoglossal cranial nerve stimulation therapy can provide significant improvement in important sleep related quality-of-life outcome measures and the effect is maintained across a 2-y follow-up period.

Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial.

Oral appliances that move the mandible forward during sleep are suggested as treatment for mild to moderate obstructive sleep apnea. To test whether an adjustable, custom-made oral appliance improves daytime sleepiness and quality of life in patients with daytime sleepiness and snoring or mild to moderate obstructive sleep apnea. Ninety-six patients with daytime sleepiness and an apnea-hypopnea index (AHI) lower than 30 were included in a randomized, placebo-controlled, parallel trial in Umeå, Sweden, from May 2007 through August 2011. Four months' intervention with an oral appliance or a placebo device. Daytime sleepiness was measured with the Epworth Sleepiness Scale, the Karolinska Sleepiness Scale, and the Oxford Sleep Resistance (OSLER) test. Quality of life was assessed with the Short-Form 36-Item Health Survey (SF-36) and the Functional Outcomes of Sleep Questionnaire (FOSQ). Secondary outcomes included the apnea-hypopnea index, headaches, symptoms of restless legs, and insomnia. Oral appliance therapy was not associated with improvements in daytime sleepiness from baseline to 4-month follow-up when compared with the placebo device; Epworth score >10: 53% at baseline to 24% at follow-up for the oral appliance group vs 54% at baseline to 40% at follow-up for the placebo device group, P = .11; median (IQR) for Karolinska score ≥7/wk: 10 (8 to 14) at baseline to 7 (4 to 9) at follow-up for the oral appliance group vs 12 (6 to 15) at baseline to 8 (5 to 12) at follow-up for the placebo device group, P = .11; mean between-group difference in OSLER test, -2.4 min (95% CI, -6.3 to 1.4). The mean between-group difference for the total FOSQ score was insignificant (-1.2 [95% CI, -2.5 to 0.1]). No domain of the SF-36 differed significantly between the groups. The AHI was below 5 in 49% of patients using the active appliance and in 11% using placebo, with an odds ratio of 7.8 (95% CI, 2.6-23.5) and a number needed to treat of 3. Snoring (P < .001) and symptoms of restless legs (P = .02) were less frequent when using the oral appliance vs placebo, but this did not apply to headache or insomnia. A custom-made, adjustable oral appliance reduces obstructive sleep apnea, snoring, and possibly restless legs without effects on daytime sleepiness and quality of life among patients with daytime sleepiness and snoring or mild to moderate sleep apnea. clinicaltrials.gov Identifier: NCT00477009.

Psychometric performance and responsiveness of the functional outcomes of sleep questionnaire and sleep apnea quality of life instrument in a randomized trial: the HomePAP study.

Measures of health-related quality of life (HRQL) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials (RCTs). We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Apnea Quality of Life Instrument (SAQLI). We evaluated the FOSQ and SAQLI construct and criterion validity, determined a minimally important difference, and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure (CPAP) adherence in a RCT population. Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea (HomePAP trial). Individuals enrolled in the HomePAP trial (n = 335). N/A. The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity, correlating with Medical Outcomes Study 36-Item Short Form Survey domains. Correlations were weaker with the Epworth Sleepiness Scale (ESS). Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy. Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference. Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness; demographic, objective obstructive sleep apnea (OSA) severity and sleep habits were not predictive in linear regression. The FOSQ and SAQLI are responsive to CPAP intervention, with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI. These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity (apnea-hypopnea index). Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) URL: http://clinicaltrials.gov/show/NCT00642486. NIH clinical trials registry number: NCT00642486.

Failure of Quality‐of‐Life Measures to Discriminate between Primary Snorers and Patients with Obstructive Sleep Apnea

Objectives: Investigate differences in quality of life (QoL) between primary snorers and obstructive sleep apnea (OSA) patients using 2 measures: Short-Form 36 (SF-36) and Functional Outcomes of Sleep Questionnaire (FOSQ). Methods: This cross-sectional study involved 69 patients who were investigated for snoring between February - December 2011. Each patient completed a SF-36 and FOSQ prior to polysomnogram. Based on polysomnogram outcomes, 4 patient groups were derived: normal, mild, moderate, and severe OSA. Variables analyzed were body-mass-index (BMI), Epworth- sleepiness-score (ESS), SF-36, and FOSQ scores. Results: Fourteen patients were normal (mean AHI 2), 14 mild OSA (mean AHI 7.7), 9 moderate OSA (mean AHI 21.9), and 32 severe OSA (mean AHI 57.5). BMI and ESS indices increased progressively from normal to severe OSA. We found no difference in SF-36’s Physical Health component among normal, mild, and moderate OSA, and though it was lowered in severe OSA this was not statistically significant (p = 0.273). Mental health component scores were similar across all groups. OSA patients scored higher across all 5 FOSQ domains compared with simple snorers, but none were statistically significant. However, primary snorers had a significantly higher (p= 0.013) self-reported health state (67.3% +/-16.85) than OSA patients (54.08% +/-17.45 ). Conclusions: The broad-based SF-36 fails to distinguish differences in QoL between normal and OSA patients. FOSQ’s psychometric properties have been reported to better reflect functional impairment caused by OSA. However, in our series, FOSQ has not been statistically significant in differentiating between patients with and without OSA.

Impact of zaleplon on continuous positive airway pressure therapy compliance.

To determine whether pretreatment with zaleplon immediately before CPAP titration improves 1-month CPAP adherence in subjects newly diagnosed with OSA. Prospective, randomized, double-blinded, placebo-controlled trial of a single dose of zaleplon 10 mg or matching placebo at the start of CPAP titration during laboratory-based, split-night polysomnography (PSG). Baseline sleep symptoms were assessed with the Functional Outcomes of Sleep Questionnaire (FOSQ) and Epworth Sleepiness Scale (ESS). CPAP usage and change in symptom questionnaire responses were assessed at 1-month follow-up. One hundred thirty-four newly diagnosed OSA patients undergoing their initial split-night PSG (49.8 ± 11.3 years old with an apnea-hypopnea index of 16.5 (7, 32) [median (interquartile range)] were randomized to zaleplon (n = 73) or placebo (n = 63). Complete follow-up data were available in 83 subjects (44 zaleplon group; 39 placebo group). CPAP was used for 6.5 (5, 7) h/day with zaleplon versus 6.5 (5, 8) h/ day with placebo (p = 0.64). Improvements in FOSQ and ESS scores did not differ between the two groups. A single dose of zaleplon at the start of a split-night CPAP titration does not result in superior CPAP adherence or improvement in symptoms at 1-month compared to placebo. Our data show that zaleplon is safe and is associated with shorter sleep latency during CPAP titration, but it does not translate into improved short-term CPAP adherence.