Functional Outcomes Of Sleep Questionnaire Research Articles

OSA Syndrome and Posttraumatic Stress Disorder: Clinical Outcomes and Impact of Positive Airway Pressure Therapy

We sought to determine the impact of OSA syndrome (OSAS) on symptoms and quality of life (QoL) among patients with posttraumatic stress disorder (PTSD). In addition, we assessed adherence and response to positive airway pressure (PAP) therapy in this population. This was a case-controlled observational cohort study at the Sleep Disorders Center of an academic military medical center. Two hundred consecutive patients with PTSD underwent sleep evaluations. Patients with PTSD with and without OSAS were compared with 50 consecutive age-matched patients with OSAS without PTSD and 50 age-matched normal control subjects. Polysomnographic data, sleep-related symptoms and QoL measures, and objective PAP usage were obtained. Among patients with PTSD, more than one-half (56.6%) received a diagnosis of OSAS. Patients with PTSD and OSAS had lower QoL and more somnolence compared with the other groups. Patients with PTSD demonstrated significantly lower adherence and response to PAP therapy. Resolution of sleepiness occurred in 82% of patients with OSAS alone, compared with 62.5% of PAP-adherent and 21.4% of nonadherent patients with PTSD and OSAS (P < .001). Similarly, posttreatment Functional Outcomes of Sleep Questionnaire ≥ 17.9 was achieved in 72% of patients with OSAS, compared with only 56.3% of patients with PTSD and OSA who were PAP adherent and 26.2% who were nonadherent (P < .03). In patients with PTSD, comorbid OSAS is associated with worsened symptoms, QoL, and adherence and response to PAP. Given the negative impact on outcomes, the possibility of OSAS should be considered carefully in patients with PTSD. Close follow-up is needed to optimize PAP adherence and efficacy in this at-risk population.

A pathway underlying the impact of CPAP adherence on intimate relationship with bed partner in men with obstructive sleep apnea.

Our aim was to determine the pathway underlying the effects of continuous positive airway pressure (CPAP) adherence on intimate relationship with bed partner in men with obstructive sleep apnea (OSA). We hypothesized that CPAP with good adherence affected the intimate relationship with bed partner directly and indirectly, and it was mediated through daytime sleepiness and activity level in men with OSA. Data were obtained from an education program for enhancing CPAP adherence. Men who were newly diagnosed of OSA and CPAP therapy naïve were recruited in a tertiary teaching hospital. Self-reported quality of life [Functional Outcomes of Sleep Questionnaire], daytime sleepiness [Epworth Sleepiness Scale (ESS)], and negative emotion symptoms [depression, anxiety, stress scale] were assessed before and after CPAP treatment at 1-year assessment. Seventy-three men were included in the data analysis, with a mean ± SD age of 52 ± 10years, body mass index of 29.0 ± 5.2kg/m(2), ESS of 9.5 ± 5.6, and median [interquartile range(IR)] apnea and hypopnea index of 31 (21, 56) events/h. The median (IR) CPAP daily usage was 4.3(0, 6.1) h/day. From the path analysis, CPAP therapy was shown to improve intimate relationship directly (ß = 0.185) and indirectly (ß = 0.050) by reducing daytime sleepiness and increasing activity level. However, negative emotion symptoms were not the mediators between CPAP adherence and the intimate relationship. CPAP therapy with good adherence is related directly and indirectly to a better intimate relationship with bed partner in men with OSA. It was possibly attributed to reduced daytime sleepiness and increased activity level.

Adaptation of the 10-Item Functional Outcomes of Sleep Questionnaire to Iranian Patients with Obstructive Sleep Apnea.

The purpose of this study was to evaluate the psychometric properties of the Farsi version of 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10) in Iranian patients with obstructive sleep apnea (OSA). The FOSQ-10 was translated into Farsi using the standard forward-backward method. One hundred patients who fulfilled the inclusion criteria completed a series of questionnaires including IR-FOSQ-10, Medical Outcome Survey Short Form 12 (SF-12) and Epworth Sleepiness Scale (ESS). Internal consistency, test-retest reliability, concurrent validity, discriminant validity and responsiveness of IR-FOSQ-10 were investigated. The Cronbach's alpha coefficient was 0.85 in IR-FOSQ-10 total score and ranged from 0.78 to 0.83 in each subscale. The test-retest reliability demonstrated by intraclass coefficient was 0.92. There were significant moderate-to-good negative correlations between IR-FOSQ-10 subscales and ESS except for sexual relationship subscale. FOSQ-10 subscales generally correlated higher with related subscales of SF-12. The IR-FOSQ-10 was able to distinguish patients with abnormal sleepiness score from those with normal sleepiness score. The results of sensitivity to change proved that the IR-FOSQ-10 was able to detect changes after continuous positive airway pressure therapy. The psychometric properties of the IR-FOSQ-10 suggest that it is a reliable and valid measure among Iranian patients with OSA.

Long-Term Effectiveness and Safety of Maxillomandibular Advancement for Treatment of Obstructive Sleep Apnea

To determine the long-term clinical effectiveness and safety of maxillomandibular advancement (MMA) for the treatment of moderate to severe obstructive sleep apnea (OSA). A prospective two-center cohort study design was used to evaluate OSA patients who underwent MMA > 2 years ago. The primary outcome measure was the apnea-hypopnea index (AHI). Secondary outcome measures included blood pressure (BP), sleepiness (Epworth Sleepiness Scale [ESS]), and quality of life (Functional Outcomes of Sleep Questionnaire [FOSQ]). 30 adult patients (80% men, age 50.5 ± 9.6 years [mean ± SD]) participated in the study. The AHI decreased from a mean of 49 to 10.9 events/h (p < 0.0001) at the time of long-term evaluation (6.6 ± 2.8 years after MMA), with 46.7% of patients obtaining an AHI < 5 and 83.4% of patients attaining an AHI ≤ 15 events/h. The mean diastolic BP decreased from 83.7 to 79.0 mm Hg (p < 0.05). ESS decreased from a mean of 12.1 to 6.0 (p < 0.01). FOSQ increased from a mean of 12.6 to 17.3 (p < 0.05). Few long-term treatment-related adverse events occurred, which had minimal impact on quality of life (QOL). MMA is a clinically effective and safe long-term treatment for most patients with moderate-to-severe OSA as demonstrated by significant decreases in AHI, diastolic BP, and subjective sleepiness, with concomitant significant improvements in QOL. The results of this small cohort study suggest that MMA should be considered as the alternative treatment of choice for patients with severe OSA who cannot fully adhere to CPAP therapy.

Clarithromycin in γ-aminobutyric acid-Related hypersomnolence: A randomized, crossover trial.

Some central hypersomnolence syndromes are associated with a positive allosteric modulator of γ-aminobutyric acid (GABA)-A receptors in cerebrospinal fluid. Negative allosteric modulators of GABA-A receptors, including clarithromycin, have been reported to reduce sleepiness in these patients. We sought to systematically assess the effects of clarithromycin on objective vigilance and subjective sleepiness. This was a 5-week, randomized, placebo-controlled, double-blind, crossover trial of clarithromycin 500mg with breakfast and lunch, in patients with hypersomnolence syndromes (excluding narcolepsy with cataplexy) and evidence for abnormal cerebrospinal fluid potentiation of GABA-A receptors. The study occurred at a university-affiliated medical center. The primary outcome measure was median reaction time on the psychomotor vigilance task (PVT) at week 2 in each condition. Secondary outcomes included the Epworth Sleepiness Scale, Stanford Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, Pittsburgh Sleep Quality Index, SF-36, and additional PVT measures. Twenty-three patients began treatment. Three patients dropped out, and final analyses were performed on 20 complete cases. Median reaction time was not significantly different between clarithromycin and placebo. Subjective measures of sleepiness were significantly improved on clarithromycin versus placebo. Altered taste perception occurred, but was the only side effect more common on clarithromycin than placebo. No serious adverse events occurred. Subjective sleepiness, but not psychomotor vigilance, improved during a 2-week course of clarithromycin. Although additional studies are needed, this suggests that clarithromycin may be a reasonable treatment option in patients with treatment-refractory hypersomnolence. This trial was registered at ClinicalTrials.gov (NCT01146600) and supported by the American Sleep Medicine Foundation.

Patients' preference of established and emerging treatment options for obstructive sleep apnoea.

Obstructive sleep apnoea (OSA) is the most common form of sleep-disordered breathing. The standard treatment, continuous positive airway pressure (CPAP), has limited long-term compliance. Alternative treatment options are required and new methods, including hypoglossal nerve stimulation (HNS) and continuous transcutaneous electrical stimulation (CTES), are currently emerging. We report on patients' preference for different treatments of OSA. We recorded patients' age, gender, body mass index (BMI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire with 10 questions (FOSQ10), severity of OSA, and current treatment. We showed pictures of existing [CPAP, mandibular advancement device (MAD)] and emerging treatments (HNS and CTES). We then asked (I) whether participants were interested in further information about HNS/CTES; (II) if they would be willing to try HNS/CTES; and (III) if they were to choose only one of the four listed treatments, which one would they prefer to use every night. One hundred sixty-two patients completed the survey {81 males, mean age 52 [12] years, BMI 34 [7] kg/m(2), ESS 10.2 (6.0) points, FOSQ10 28.5 (8.1) points}. The majority of the respondents (89.5%) had been diagnosed with OSA. A total of 91.3% of the respondents were interested in more information and were willing to try HNS/CTES. Most respondents preferred the potential use of CTES (56.7%), while 21.7% chose HNS, 17.8% CPAP, and 3.8% the MAD. There were no differences in the characteristics of the patients who preferred CTES compared to those who preferred other treatments, but a regression analysis revealed that a low ESS score was an independent predictor of patients choosing CTES (P<0.05). More than 9 out of 10 of the respondents were interested in trying emerging technologies to treat OSA, most preferring CTES. Less sleepy patients were more likely to choose less invasive treatments. These findings will likely impact on future research and development of therapies for sleep-disordered breathing.

Effect of APAP and heated humidification with a heated breathing tube on adherence, quality of life, and nasopharyngeal complaints.

Positive airway pressure (PAP) therapy adherence can be affected by rhinitis sicca and xerostomia complaints. Additional heated humidification (HH) is the appropriate method when such complaints arise. The aim of this study was to determine if HH with a supplementary heated breathing tube can increase adherence, reduce subjective nasopharyngeal complaints (NPC), and improve sleepiness (ESS: Epworth Sleepiness Scale) and quality of life (FOSQ: Functional Outcome of Sleep Questionnaire). We subdivided 72 obstructive sleep apnea (OSA) patients into two groups before therapy initiation. The NPC risk group consists of subjects with NPC and the low-risk group without. The risk group was identified by a score of >9 in a 5-item 25-point NPC questionnaire and pathological ESS. All patients were eligible for automatic CPAP devices (APAP), which were randomly configured with or without HH during 6 weeks. The adherence differences with and without HH were not significant in the NPC risk group (330 ± 103 vs. 281 ± 118 min/night) and in the low-risk group (330 ± 116 vs. 321 ± 89). NPC and ESS scores in the risk group were both significantly reduced with HH. Daily function (FOSQ) in the risk group was significantly improved with HH (90.0 ± 11.9 vs. 82.0 ± 12.0 (p < 0.05)). HH showed a tendency to improve APAP adherence. The adherence in both groups was quite high, and for that reason, it is difficult to show a statistically significant effect. A differentiation into NPC risk groups before starting PAP treatment is useful. HH reduces side effects and sleepiness and improves quality of life in an NPC risk group.

Subjective sleep disturbances and quality of life in chronic tetraplegia.

This is a cross-sectional survey. The objective of this study was to evaluate the subjective sleep disturbances and quality of life in chronic tetraplegia. This study was conducted in a community sample from Victoria, Australia. People with tetraplegia were mailed a survey battery including the following: demographic questions; Karolinska Sleepiness Scale (KSS); Basic Nordic Sleepiness Questionnaire; Functional Outcomes of Sleep Questionnaire (FOSQ); Multivariate Apnoea Prediction Index and Assessment of Quality of Life (AQoL) Questionnaire. Scores were compared with the best available normative data. A total of 163 of 424 (38%) surveys were returned (77% male; 39% sensory and motor complete; mean age±s.d.=46±14 years; mean years since injury=11±8 years). The AQoL health utility score (0.31±0.29) was significantly lower than published population norms. FOSQ total (17.55±2.57) and KSS (3.93±2.27) scores were no different from the best available population data. People with tetraplegia reported worse sleep habits, symptoms and quality than a normal population, as indicated on 17 of 21 questions on the Basic Nordic Sleep Questionnaire. Multivariate analysis found that greater injury severity (coefficient (95% CI)=0.14 (0.10, 0.18)), increasing age (-0.004 (-0.008, -0.001)) and worse sleep symptoms (-0.005 (-0.009, -0.0003)) were all significantly associated with reduced quality of life. People with chronic tetraplegia experience more subjective sleep problems and worse quality of life than their able-bodied counterparts. Quality of life is related to injury severity, age and sleep symptoms. Treating the sleep disorders experienced by people living with tetraplegia has the potential to improve their health and well-being.

Health-related stigma as a determinant of functioning in young adults with narcolepsy.

Symptoms of narcolepsy tend to arise during adolescence or young adulthood, a formative time in human development during which people are usually completing their education and launching a career. Little is known about the impact of narcolepsy on the social aspects of health-related quality of life in young adults. The purpose of this study was to examine relationships between health-related stigma, mood (anxiety and depression) and daytime functioning in young adults with narcolepsy compared to those without narcolepsy. Young adults (age 18–35) with narcolepsy (N = 122) and without narcolepsy (N = 93) were mailed a packet that included questionnaires and a self-addressed postage paid envelope. The questionnaire included demographic information and a composite of instruments including the SF 36, Functional Outcomes of Sleep Questionnaire (FOSQ), Fife Stigma Scale (FSS), Epworth Sleepiness Scale (ESS) and Hospital Anxiety and Depression Scale (HADS). Variable associations were assessed using descriptive statistics, ANOVA, Mann-Whitney U Test, correlations, stepwise multiple regression and path analysis. Young adults with narcolepsy perceived significantly more stigma and lower mood and health-related quality of life than young adults without narcolepsy (p<0.01). Health-related stigma was directly and indirectly associated with lower functioning through depressed mood. Fifty-two percent of the variance in functioning was explained by the final model in the young adults with narcolepsy. Health-related stigma in young adults with narcolepsy is at a level consistent with other chronic medical illnesses. Health-related stigma may be an important determinant of functioning in young adults with narcolepsy. Future work is indicated toward further characterizing stigma and developing interventions that address various domains of stigma in people with narcolepsy.

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.

Efficacy of Pulmonary Rehabilitation Program with Cycle Ergometer in Obstructive Sleep Apnea Syndrome

Background and objectives: Obstructive Sleep Apnea Syndrome (OSAS) is characterized by recurrent upper airway obstruction during sleep. The aim of this study was to investigate impact of respiratory rehabilitation program with cycle ergometer on exercise capacity, respiratory parameters, sleep and quality of life in OSAS. Patients and methods: Study population was consisted of mild and moderate OSAS patients aged 18-65. Controlled breathing techniques and respiratory muscle exercises were asked to practice 2 times a day for 10-20 minutes. Upperlimb muscles of the shoulder girdle and cycle ergometer exercise device consisting of aerobic exercise and resistance programs we implement, was performed 3 times a week for 50-60 minutes. Anthropometric measurements, respiratory function tests; exercise capacity, 6 Minute Walk Test; level of day time sleepiness the Ep worth Sleepiness Scale; sleep and quality of life, Functional Outcome of Sleep Questionnaire and the Short Form-36 Questionnaire; anxiety levels were assessed using the State-Trait Anxiety Inventory. Results: 40 patients were included in the study. After treatment, neck circumference, level of daytime sleepiness, resting and post-exercise heart rate and blood pressure response, dyspnea and leg fatigue decreased; and improved exercise capacity, MIP, quality of life and sleep were observed. Conclusion: PR may be an effective treatment option in patients with OSAS. To our knowledge this is the first report that demonstrating the effectiveness of cycling exercises on functional status, exercise capacity, life and sleep quality in patients with OSAS.

Auto-adjusting positive airway pressure treatment for sleep apnea diagnosed by home sleep testing.

Compare auto-adjusting positive airway pressure (APAP) treatment with positive airway pressure (PAP) titration by polysomnography (PSG) followed by CPAP treatment in patients diagnosed with obstructive sleep apnea (OSA) by home sleep apnea testing (HSAT). Prospective randomized treatment study. Tertiary Veterans Administration Medical Center. 156 patients diagnosed with OSA by HSAT (apneahypopnea index [AHI] ≥ 10/h) suitable for APAP treatment. APAP arm: Treatment with an APAP device, CPAP arm: PSG PAP titration followed by CPAP treatment. Mean PAP adherence, Epworth sleepiness scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ). The mean (± SD) age, BMI, and diagnostic AHI (APAP: 28.6 ± 18.5, CPAP: 28.3 ± 16.0/h, p = NS) did not differ between the study arms. After 6 weeks of treatment, 84.6% of 78 patients started on APAP and 84.3% of 70 patients started on CPAP (8 declined treatment after the titration) were using PAP, p = NS. The 90% APAP and level of CPAP were similar (10.8 ± 3.1, 11.7 ± 2.5 cm H2O, p = 0.07). The average nightly PAP use did not differ (APAP: 4.45 ± 2.3, CPAP: 4.0 ± 2.3 h, p = NS). The improvements in the ESS (APAP: -4.2 ± 4.7, CPAP: -3.7 ± 4.8, p = NS) and in the FOSQ (APAP: 2.6 ± 3.5, CPAP: 2.2 ± 3.7, p = NS) were not different. Following diagnosis of OSA by HSAT, treatment with APAP results in equivalent PAP adherence and improvement in sleepiness compared to a PSG titration and CPAP treatment. A commentary on this article appears in this issue on page 1277.

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.

P295 Patients' Preference Of Established And Emerging Treatments For Obstructive Sleep Apnoea

Background Obstructive sleep apnoea (OSA) is the most common form of sleep-disordered breathing, and the standard treatment is continuous positive airway pressure (CPAP). Emerging treatments for OSA, including electrical hypoglossal nerve stimulation (HNS) and non-invasive electrical stimulation (nES), are currently being developed. To involve patients in the development of research projects, we evaluated patients’ preference for different treatments of OSA using a short survey. Patients and methods We recorded patients’ age, gender, body-mass-index (BMI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ10), severity of OSA, and current treatment. We showed pictures of existing (CPAP, mandibular advancement device (MAD)) and emerging treatments (HNS and nES). We then asked 1) whether they were interested in further information about HNS/nES, 2) if they would be willing to try HNS/nES, and 3) if they were to choose only one of the four listed treatments, which one would they prefer to use every night. Results 162 patients completed the survey (81 males, mean age 52 (12) years, BMI 34 (7.3) kg/m2, ESS 10.2 (6.0) points, FOSQ10 28.5 (8.1) points). The majority of the respondents (89.5%) had been diagnosed with OSA, with 95.4% of those being treated with CPAP. 91.3% of the respondents were interested in more information and were willing to try HNS/nES. Most respondents preferred the potential use of nES (56.7%), while 21.7% chose HNS, 17.8% CPAP, and 3.8% the MAD. There were no differences in the characteristics of the patients who preferred nES compared to those who preferred other treatments; however, a regression analysis showed that a low ESS score was a predictor of patients choosing nES (p Conclusion Although the CPAP is the established treatment for OSA, most patients would prefer alternatives for long-term treatment. The majority of the respondents were interested in emerging technologies, with less sleepy patients more likely to choose less invasive treatment options.

Does Race-Ethnicity Moderate the Relationship between CPAP Adherence and Functional Outcomes of Sleep in US Veterans with Obstructive Sleep Apnea Syndrome?

Little is known about the association of race-ethnicity and the relationship of continuous positive airway pressure (CPAP) adherence with functional outcomes of sleep in American samples with obstructive sleep apnea syndrome (OSAS). This retrospective study examines whether race-ethnicity moderates the relationship between CPAP adherence and functional outcomes of sleep in OSAS. Over 4 months, consecutive OSAS patients had CPAP data downloads and completed questionnaires (demographics, Functional Outcomes of Sleep Questionnaire [FOSQ], Epworth Sleepiness Scale [ESS], Insomnia Severity Index [ISI]) at the Miami VA sleep center. Medical diagnoses and polysomnography data were obtained from medical record. CPAP adherence was measured as mean daily hours of use. Hierarchical regression modeling was used to explore the differential impact of race-ethnicity and CPAP adherence on functional outcomes of sleep. Two hundred twenty-seven veterans (93% male, age 59 ± 11 years) were included; 142 (63%) participants self-reported as white or Hispanic, and 85 participants (37%) as black. Hierarchical regression analyses failed to show main effects for race-ethnicity or CPAP use and FOSQ scores; however, the interaction of race-ethnicity with CPAP adherence was significantly associated with the total FOSQ (p = 0.04), Social (p = 0.02), and Intimacy (p = 0.01) subscale scores. For blacks, in adjusted analyses, CPAP adherence was positively associated with Social and Intimacy FOSQ subscales; however, no significant relationship was noted between CPAP use and FOSQ scores in whites/Hispanics. Race-ethnicity may moderate the relationship between CPAP adherence and some functional outcomes of sleep; however, further studies are needed.

Randomized controlled withdrawal study of upper airway stimulation on OSA: short- and long-term effect.

To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures. A randomized controlled therapy withdrawal study. Industry-supported multicenter academic and clinical setting. A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants. Participants were randomized to either therapy maintenance ("ON") group or therapy withdrawal ("OFF") group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed. Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months. Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.

Randomized Treatment Withdrawal of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Objectives: Describe the therapeutic effect of upper airway stimulation (UAS) therapy withdrawal on objective and subjective measures of sleep apnea severity. Methods: From a cohort of 126 participants in a prospective therapy effectiveness trial, 46 subjects were randomized to therapy “ON” and “OFF” groups. Primary outcomes measures were apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) changes and secondary outcome measures included Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), sleep architecture, hypoxemia, snoring, and blood pressure. Results: Groups did not differ at pretreatment baseline or at 12 months of therapy in polysomnography or self-reported measures. Following randomized controlled trial (RCT) therapy withdrawal, change in AHI and ODI significantly differed in “ON” and “OFF” groups (1.7 versus 18.2 and 1.6 versus 17.0 events/hour P &lt; .0001). Therapy withdrawal worsened ESS, FOSQ, snoring, hypoxemia, and arousal index in the therapy “OFF” but no change was observed in the “ON” group ( P &lt; .001). The therapy “ON” group demonstrated a reduction in blood pressure at 12 months compared to baseline which was maintained through the RCT. Conclusions: Withdrawal of therapeutic UAS results in relapse of both subjective and objective measures of OSA.

Nonrandomized Prospective Study of an Upper Esophageal Sphincter (UES) Assist Device for Treating Laryngopharyngeal Reflux

Objectives: (1) Describe treatment of the heterogeneous disorder of laryngopharyngeal reflux (LPR) with a new upper esophageal sphincter (UES) assist medical device designed to eliminate the reflux of gastric contents into the laryngopharynx. (2) Analyze the reduction of symptoms pre-therapy compared to posttherapy. Methods: Patients presenting with a reflux symptoms index (RSI) &gt;13 and diagnosed with chronic cough, postnasal drip, globus, or throat clearing were included in the study. The UES assist device was fitted individually to apply external pressure above 20 mm Hg at the cricoid and worn when sleeping. The primary effectiveness endpoint was reduction of the RSI at 4 weeks. SF-36 Health Survey, Functional Outcomes of Sleep Questionnaire (FOSQ), and patient and physician satisfaction scores were secondary end points. Intent to treat (ITT) analysis was performed. Safety was based on reported adverse reactions. Results: Forty-four patients consented, with 42 (ITT) completing the study (age, 47 ± 13.1 years; body mass index, 24.8 ± 3.5; 66% female; 75% Caucasian). Most troublesome symptoms were post nasal drip, throat clearing, and annoying cough. Adverse events were mild and short in duration with no study withdrawals due to an adverse event. There was a significant ( P &lt; .0001) reduction of the RSI at 2 weeks (13.2 ± 8.8) and 4 weeks (10.2 ± 7.6) posttherapy compared with pretherapy (24.5 ± 5.9). Ninety-one percent of patients improved at least 25% with 33% improving at least 75%. Conclusions: The UES assist device is a safe and effective noninvasive method for the treatment of LPR and provides clinical utility within 2 weeks. This could be a potential alternative for LPR before considering medications or surgery.

Sleep Surgery Variations: The Evolution of Surgery for Obstructive Sleep Apnea at an Academic Hospital

Objectives: (1) Identify surgeon dependent and temporal variations in indications and surgical interventions for obstructive sleep apnea (OSA) at a tertiary academic hospital. (2) Clarify if volume of sleep surgeries performed affects outcomes. (3) Determine if surgical volume correlates with technical variation (ie, do surgeons who perform more surgeries for OSA perform additional procedures beyond uvulopalatopharyngoplasty [UPPP]). Methods: Retrospective chart review: Adult patients who had undergone UPPP since 2003 and had electronic medical records available were included. Quality of life (QOL) instruments included in the electronic medical record such as the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) were included. Pre- and postoperative results were compared using standard statistical analysis. Results: A total of 247 patients met inclusion criteria. Median AHI of all patients with available postoperative PSG decreased from 39.4 to 21.4. Patients of high-volume surgeons (&gt;10 UPPP per year) were more likely to have a lower preoperative Friedman score ( P &lt; .02), complete a postoperative PSG ( P &lt; .0001 by the 2-tailed Fisher exact test), have a decreased postoperative ESS ( P &lt; .01), and have a PSG completed sooner after surgery ( P &lt; .01). Postoperative AHI and change in AHI did not differ between groups, however ( P = .21 and P = .14, respectively). Conclusions: UPPP contributes to objective improvement in PSG measures and quality of life. Nuances in patient selection and patient management are apparent between high volume surgeons and others, and may contribute to quality of life variations. Standardization of patient selection, timing of postoperative PSG, and increased utilization of QOL instruments may improve QOL outcomes among surgeons who do not perform UPPP regularly.

Validity of Korean Version of Functional Outcomes of Sleep Questionnaire in Patients with Simple Snoring and Obstructive Sleep Apnea

Background and ObjectiveaaWe developed a Korean version of the Functional Outcomes of Sleep Questionnaire (K-FOSQ) and investigated its reliability and validity in simple snorer or obstructive sleep apnea (OSA) patients. MethodsaaA total 432 participants (70% men, 84% OSA, mean age 50.0 ± 9.8 years) who were simple snorers or had OSA were included. We assessed the internal consistency, test-retest reliability, factor analysis, multitrait scaling analysis, and the concurrent validity of the K-FOSQ. Participants completed a battery of questionnaires including the Epworth Sleepiness Scale (ESS), Short Form-36 Health Survey (SF-36), Medical Outcomes Study-Sleep (MOS-Sleep) Scale, and Beck Depression Inventory (BDI). ResultsaaFactor analysis identified five factors, in which only 24 items met the loading criteria. The five factors of K-FOSQ accounted for 73.0% of the variance. Cronbach’s alpha coefficient for all domains exceeded the 0.70 standard for internal consistency. Test-retest re liability was acceptable (r = 0.41–0.93). Item-domain correlations ranged from 0.37 to 0.90. Only one item did not reach the threshold of 0.40. Floor effects were not observed, but ceiling effects were marked on all K-FOSQ subscales except one. All domains of K-FOSQ were significantly correlated with the corresponding scores of all tested instruments. The global K-FOSQ had a strong correlations (r > 0.50) with ESS and Sleep Problem Index-2 of MOS-Sleep, and had medium-sized correlations (r = 0.40–0.50) with BDI and SF-36 total scores. The K-FOSQ global and subscales did discriminate between participants with and without daytime sleepiness, but not between simple snorers and OSA patients.