Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry.
ABSTRACT: Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7?events·h-1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.
Project description:The aim of the study was to compare REM-dependent and REM-independent, obstructive sleep apnea syndrome (OSA) patients in relation to their daily sleepiness assessed by Epworth sleepiness scale (ESS). The study included 1863 consecutive patients, who were referred to a sleep centre with a presumed diagnosis of OSA. Following polysomnography, 292 patients fulfilled criteria for either REM-dependent OSA (REM-OSA, n?=?102) or REM-independent OSA (nREM-OSA, n?=?190). Both study groups were matched regarding sex and age. REM-OSA group had two times lower median apnoea-hypopnea index (AHI) compared to nREM-OSA (p?<?0.001), yet day-time sleepiness measured by ESS was similar: median score 9.0 (6.0-11.0) and 8.0 (4.8-11.0), p?=?0.109, respectively. Subsequent post-hoc ANCOVA analysis, with covariates (BMI, percent of total sleep time spent in REM stage, percent of total sleep time spent in the supine position), has shown statistically significant difference between study groups regarding AHI (p?<?0.001) and no difference regarding ESS score (p?=?0.063). Despite two times lower AHI, patients with REM-OSA present with similar day-time sleepiness as those with REM independent OSA. Daily sleepiness may be stronger associated with apneas/hypopneas occurring in REM than nREM sleep.
Project description:OBJECTIVES:Up to 77% of patients with obstructive sleep apnoea (OSA) have positional OSA (POSA) but traditional positional therapy (PT) methods have failed as they were poorly tolerated. New convenient vibratory PT devices have been invented but while recent studies suggest high treatment efficacy and adherence, there are no published data comparing these devices directly with continuous positive airway pressure (CPAP). Our objective is to evaluate if a convenient vibratory PT device is non-inferior to CPAP in POSA treatment. METHODS:In this crossover randomised controlled trial, we enrolled patients with POSA with significant daytime sleepiness (Epworth Sleepiness Scale (ESS)?10). POSA diagnosis was based on: (1) total Apnoea/Hypopnoea Index (AHI)>10/hour and non-supine AHI<10/hour (2) supine AHI?2?× non-supine AHI. Patients used their initial allocated devices (PT or CPAP) for 8 weeks before crossing to the alternative intervention after a 1?week washout. The primary aim is to measure changes in ESS between the two treatments. Secondary outcomes include sleep study parameters and patient treatment preference (ClinicalTrials.gov: NCT03125512). RESULTS:40 patients completed the trial between April 2017 and December 2018. Difference in ESS after 8 weeks of device use (PT minus CPAP) was 2.0 (95% CI 0.68 to 3.32), exceeding our predetermined non-inferiority margin of 1.5. AHI on CPAP was lower than with PT (4.0±3.2 vs 13.0±13.8 events/hour, respectively, p=0.001), although both were lower than at baseline. Time spent supine was significantly lower with PT than CPAP (p<0.001). 60% of patients preferred CPAP, 20% preferred PT, while 20% preferred neither device. CONCLUSIONS:The non-inferiority ESS endpoint for PT compared with CPAP was not met and the results were inconclusive. Future trials with larger sample sizes or in less symptomatic patients are warranted to provide further insight into the role of these new vibratory PT devices.
Project description:BackgroundThe relationship between the Epworth sleepiness scale (ESS) and the apnea-hypopnea index (AHI) is uncertain and even poor. The major problem associated with the ESS might be a lack of consideration of weight in prediction in clinical practice. Would awarding different item-scores to the four scales of ESS items to develop a weighted ESS scoring system improve the accuracy of the AHI prediction? It is warranted to explore the intriguing hypotheses.MethodsSeven hundred fifty-six adult patients with suspicion of obstructive sleep apnoea syndrome (OSAS) were prospectively recruited to a derivation cohort. This was tested against a prospective validation cohort of 810 adult patients with suspected OSAS. Each ESS item’s increased odds ratio for the corresponding AHI was calculated using univariate logistic regression. The receiver operating characteristic curves were created and the areas under the curves (AUCs) were calculated to illustrate and compare the accuracy of the indices.ResultsThe higher the ESS item-score, the closer the relationship with the corresponding AHI. The odds ratios decreased as a result of the increased AHI. The ESS items were of unequal weight in predicting the corresponding AHI and a weighted ESS was developed. The coincidence rates with the corresponding AHI, body mass indices, and neck circumferences rose as the scores increased, whereas nocturnal nadir oxygen saturations decreased, and the weighted ESS was more strongly associated with these indices, compared with the ESS. The capability in predicting the patients without OSAS or with severe OSAS was strong, especially the latter, and the weighted ESS orchestrated manifest improvement in screening the patients with simple snoring. The patterns of sensitivities, specificities, and Youden’s indices of the four ranks of weighted ESS for predicting the corresponding AHI were better than those of the ESS, and the AUCs of weighted ESS were greater than the corresponding areas of ESS in the two cohorts.ConclusionsThe weighted ESS orchestrated significant improvement in predicting the AHI, indicating that the capability in predicting the patients without OSAS or with severe OSAS was strong, which might have implications for clinical triage decisions to prioritize patients for polysomnography.
Project description:BACKGROUND:Sleep-disordered breathing (SDB) is common in patients with kidney disease; but often underdiagnosed as it is infrequently assessed in clinical practice. The objective of this study was to assess the risk factors of SDB in haemodialysis patients, and to identify useful assessment tools to detect SDB in this population. METHODS:We used nocturnal oximetry, Epworth Sleepiness Scale (ESS) and STOPBANG questionnaire to screen for SDB in haemodialysis patients. Presence of SDB was defined by Oxygen desaturation index (ODI?5/h), and further confirmed by apnoea-hypopnea index (AHI) from an in-laboratory polysomnography. Blood samples were collected prior to commencing a haemodialysis treatment. RESULTS:SDB was detected in 70% of participants (N = 107, mean age 67 years). STOPBANG revealed that 89% of participants were at risk of SDB; however, only 17% reported daytime sleepiness on the ESS. Of the participants who underwent polysomnography (n = 36), obstructive sleep apnoea was identified in 86%, and median AHI was 34.5/h. Oximetry and AHI results were positively correlated (r = 0.62, P = 0.0001), as were oximetry and STOPBANG (r = 0.48; P<0.0001), but not ESS (r = 0.19; P = 0.08). Multivariate analysis showed that neck circumference (OR: 1.20; 95% CI: 1.07-1.34; P = 0.02) and haemoglobin (OR: 0.93; 95% CI: 0.88-0.97; P = 0.003) were independently associated with the presence of SDB. CONCLUSION:Dialysis patients with a large neck circumference and anaemia are at risk of SDB; using nocturnal oximetry is practical and reliable to screen for SDB and should be considered in routine management of dialysis patients, particularly for those who demonstrate risk factors.
Project description:Background: Obstructive sleep apnoea and obese hypoventilation is not uncommon in patients with obesity. Residuals effect from surgery/anaesthesia and opioid analgesics may worsen respiration during the first nights after bariatric surgery. The aim of this observational study was to monitor respiration on the first postoperative night following elective bariatric surgery. Methods: This observational study aimed to determine the incidence and severity of hypo/apnoea in low risk obsess patients undergoing elective bariatric surgery in general anesthaesia. Patients with known or suspected sleep respiratory disturbances was not included. ESS was scored prior to surgery. Oxygen desaturation was analyzed by continuous respiratory monitoring. Mean oxygen saturation (SpO2), nadir SPo2, apnoea/hypopnea index and oxygen desaturation index was assess by standard tools. Results: 45 patients were monitored with portable polygraphy equipment (Embletta, ResMed) during the first postoperative night at the general ward following elective laparoscopic bariatric surgery. The prop ESS was 0-5 in 22, 6-10 in 14 and 11-16 in 6 of the patients studied (missing data 3). Mean SpO2 was 93%; 10 patients had a mean SpO2 of less than 92% and 4 of less than 90%. The lowest mean SpO2 was 87%. There were 16 patients with a nadir SpO2 of less than 85%, lowest nadir SpO2 being 63%. An Apnoea Hypo/apnoea Index (AHI) > 5 was found in 2 patients only (AHI 10 and 6), and an Oxygen Desaturation index (ODI) > 5 was found in 3 patients (24, 10 and 6, respectively). 3 patients had more prolonged (> 30 seconds) apnoea with nadir SpO2 81%, 83% and 86%. ESS score and type of surgery did not impact on respiration/oxygenation during the observation period. Conclusions: A low mean SpO2 and episodes of desaturation were not uncommon during the first postoperative night following elective bariatric surgery in patients without history of night time breathing disturbance. AHI and/or ODI of more than 5 were only rarely seen. Night-time respiration monitoring provided seemingly sparse additional information. Further studies are need to assess risk factors and potential impact of the desaturation episodes that occurs during sleep.
Project description:The purpose of this study was to evaluate the correlation between severity of obstructive sleep apnoea syndrome (OSAS), cardiovascular disease and metabolic syndrome. We recruited 1185 patients with OSAS who underwent a complete ENT examination, including nasolaryngeal fibre optic endoscopy with Müller's manoeuvre, overnight cardio-respiratory monitoring, Epworth Sleepiness Scale (ESS) to measure daytime sleepiness, body mass index (BMI), measurement of blood pressure and blood tests.SUBSEQUENTLY, SUBJECTS WERE DIVIDED INTO THREE SUBGROUPS ACCORDING TO THE APNOEA HYPOPNOEA INDEX (AHI): mild OSAS (AHI 5-15), moderate OSAS (AHI 15-30) and severe OSAS (AHI > 30). In the sample collected, 347 (262 males and 85 females) of 1185 patients suffered from mild OSAS, 363 (269 males and 94 females) from moderate OSAS and 475 (330 males and 145 females) from severe OSAS. In the group suffering from mild OSAS, we found: 127 patients affected by hypertension, 48 with diabetes, 11 with dyslipidaemia and 32 with metabolic syndrome. In the group with moderate OSAS there were 157 patients with hypertension, 63 with diabetes, 72 with dyslipidaemia and 47 with metabolic syndrome. In the group suffering from severe OSAS there were 244 patients with hypertension, 138 with diabetes, 47 with dyslipidaemia and 90 with metabolic syndrome. For data analysis, we used the Spearman correlation test adjusted according to Sidak between the dependent variable AHI and the independent variables BMI, ESS, average SO2 (SO(2med)), hypertension, diabetes mellitus, dyslipidaemia and metabolic syndrome. The results show different patterns of correlation in terms of statistical significance: BMI ?(s) = 0.26, SO(2med) ?(s) = -0:51, hypertension ?(s) = -0.05, dyslipidaemia ?(s) = 0.22 for women, and BMI ?(s) = 0.53, ESS ?(s) = 0.28, SO(2med) ?(s) = -0.50, hypertension ?(s) = 0.17, diabetes mellitus ?(s) = 0.28 and metabolic syndrome ?(s) = 0.26 for men. The results of the study confirm the existence of a statistically significant correlation between the severity of OSAS and BMI, ESS, average SO2, hypertension, diabetes mellitus, dyslipidaemia and metabolic syndrome.
Project description:Study Objectives:There remains an important and unmet need for fully effective and acceptable treatments in obstructive sleep apnea (OSA). At present, there are no approved drug treatments. Dronabinol has shown promise for OSA pharmacotherapy in a small dose-escalation pilot study. Here, we present initial findings of the Phase II PACE (Pharmacotherapy of Apnea by Cannabimimetic Enhancement) trial, a fully blinded parallel groups, placebo-controlled randomized trial of dronabinol in people with moderate or severe OSA. Methods:By random assignment, 73 adults with moderate or severe OSA received either placebo (N = 25), 2.5 mg dronabinol (N = 21), or 10 mg dronabinol (N = 27) daily, 1 hour before bedtime for up to 6 weeks. Results:At baseline, overall apnea-hypopnea index (AHI) was 25.9 ± 11.3, Epworth Sleepiness Scale (ESS) score was 11.45 ± 3.8, maintenance of wakefulness test (MWT) mean latency was 19.2 ± 11.8 minutes, body mass index was 33.4 ± 5.4 kg/m2, and age was 53.6 ± 9.0 years. The number and severity of adverse events, and treatment adherence (0.3 ± 0.6 missed doses/week) were equivalent among all treatment groups. Participants receiving 10 mg/day of dronabinol expressed the highest overall satisfaction with treatment (p = .04). In comparison to placebo, dronabinol dose-dependently reduced AHI by 10.7 ± 4.4 (p = .02) and 12.9 ± 4.3 (p = .003) events/hour at doses of 2.5 and 10 mg/day, respectively. Dronabinol at 10 mg/day reduced ESS score by -3.8 ± 0.8 points from baseline (p < .0001) and by -2.3 ± 1.2 points in comparison to placebo (p = .05). MWT sleep latencies, gross sleep architecture, and overnight oxygenation parameters were unchanged from baseline in any treatment group. Conclusions:These findings support the therapeutic potential of cannabinoids in people with OSA. In comparison to placebo, dronabinol was associated with lower AHI, improved self-reported sleepiness, and greater overall treatment satisfaction. Larger scale clinical trials will be necessary to clarify the best potential approach(es) to cannabinoid therapy in OSA.
Project description:OBJECTIVE/HYPOTHESIS:The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA. STUDY DESIGN:Cohort Study. METHODS:Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ?50% decrease in Apnea-Hypopnea Index (AHI) and AHI ?20 at the 12-month visit. RESULTS:The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8?±?15.4 to 14.2?±?15.0, P?<?.0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4?±?5.6 to 7.2?±?4.8, P?<?.0001. Therapy usage was 5.6?±?2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response. CONCLUSIONS:Across a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high. LEVEL OF EVIDENCE:2 Laryngoscope, 130:1333-1338, 2020.
Project description:Positional therapy is a simple means of therapy in sleep apnoea syndrome, but due to controversial or lacking evidence, it is not widely accepted as appropriate treatment. In this study, we analysed data to positional therapy with regard to successful reduction of AHI and predictors of success.All consecutive patients undergoing polysomnography between 2007 and 2011 were analysed. We used a strict definition of positional sleep apnoea syndrome (supine-exclusive sleep apnoea syndrome) and of therapy used. Patients underwent polysomnography initially and during follow-up.1275 patients were evaluated, 112 of which had supine-exclusive sleep apnoea syndrome (AHI 5-66/h, median 13/h), 105 received positional therapy. With this treatment alone 75% (70/105) reached an AHI <5/h, in the follow-up 1 year later 37% (37/105) of these still had AHI<5/h, 46% (43/105) yielded an AHI between 5 and 10/h. Nine patient switched to APAP due to deterioration, 3 wanted to try APAP due to comfort reasons. At the last follow-up, 32% patients (34/105) were still on positional therapy with AHI <5/h. BMI was a predictor for successful reduction of AHI, but success was independent of sex, the presence of obstructive versus central sleep apnoea, severity of sleep apnoea syndrome or co-morbidities.Positional therapy may be a promising therapy option for patients with positional sleep apnoea. With appropriate adherence it yields a reasonable success rate in the clinical routine.
Project description:To validate the utilities of Berlin, STOP and STOP-BANG Questionnaires, other patient characteristics, comorbidities, Epworth Sleepiness Scale (ESS), fractional exhaled nitric oxide (FENO) and blood markers for the prediction of sleep disordered breathing (SDB) on limited polygraphy.North Glasgow Sleep Service (a tertiary referral centre).129 consecutive patients, aged ?16 years, referred to the sleep clinic for assessment of possible obstructive sleep apnoea.We selected cut-points of apnoea hypopnoea index (AHI) of ?5 and ?15/h from their home polygraphy and determined associations of these with individual symptoms, questionnaire scores and other results. Receiver operating characteristic analysis and univariate and multivariate logistic regression were used to explore these.Primary: The utility of STOP, STOP-BANG and Berlin Questionnaires for prediction of SDB. Secondary: The utility of other measures for prediction of SDB.AHI was ?5 in 97 patients and ?15 in 56 patients. STOP and STOP-BANG scores were associated with both AHI cut-points but results with ESS and Berlin Questionnaire scores were negative. STOP-BANG had a negative predictive value 1.00 (0.77-1.00) for an AHI ?15 with a score ?3 predicting AHI ?5 with sensitivity 0.93 (95% CI 0.84 to 0.98) and accuracy 79%, while a score ?6 predicted AHI ?15 with specificity 0.78 (0.65 to 0.88) and accuracy 72%. Neck circumference ?17 inch and presence of witnessed apnoeas were independent predictors of SDB.STOP and STOP-BANG Questionnaires have utility for the prediction of SDB in the sleep clinic population. Modification of the STOP-BANG Questionnaire merits further study in this and other patient groups.