| 1. |
- Basoglu, Ozen K, et al.
(författare)
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Change in weight and central obesity by positive airway pressure treatment in obstructive sleep apnea patients: longitudinal data from the ESADA cohort.
- 2018
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Ingår i: Journal of sleep research. - : Wiley. - 1365-2869 .- 0962-1105. ; 27:6
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Tidskriftsartikel (refereegranskat)abstract
- The effect of positive airway pressure treatment on weight and markers of central obesity in patients with obstructive sleep apnea remains unclear. We studied the change in body weight and anthropometric measures following positive airway pressure treatment in a large clinical cohort. Patients with obstructive sleep apnea with positive airway pressure treatment from the European Sleep Apnea Database registry (n=1,415, 77% male, age 54±11 [mean±SD] years, body mass index 31.7±6.4kg/m2 , apnea-hypopnea index 37±24n per hr, Epworth Sleepiness Scale 10.2±5.0) were selected. Changes in body mass index and neck/waist/hip circumferences at baseline and at follow-up visit were analysed. Overall, body mass index (0.0 [95% confidence interval, -0.1 to 0.2]kg/m2 ) and neck circumference (0.0 (95% confidence interval, -0.1 to 0.1]cm) were unchanged after positive airway pressure treatment compared with baseline (follow-up duration 1.1±1.0years and compliance 5.2±2.1hr per day). However, in non-obese (body mass index <30kg/m2 ) patients, positive airway pressure treatment was associated with an increased body mass index and waist circumference (0.4 [0.3-0.5]kg/m2 and 0.8 [0.4-1.2]cm, respectively, all p<0.05), and weight gain was significantly associated with higher positive airway pressure compliance and longer positive airway pressure treatment duration. In the obese subgroup, body mass index was reduced after positive airway pressure treatment (-0.3 [-0.5 to -0.1]kg/m2 , p<0.05) mainly in patients with a strong reduction in Epworth Sleepiness Scale. In conclusion, positive airway pressure therapy was not found to systematically change body mass index in the European Sleep Apnea Database cohort, but the response was heterogeneous. Our findings suggest that weight gain may be restricted to an obstructive sleep apnea phenotype without established obesity. Lifestyle intervention needs to be considered in both lean and obese patients with obstructive sleep apnea receiving positive airway pressure treatment.
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| 2. |
- Dieltjens, Marijke, et al.
(författare)
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Use of the Clinical Global Impression scale in sleep apnea patients-Results from the ESADA database.
- 2019
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Ingår i: Sleep medicine. - : Elsevier BV. - 1878-5506 .- 1389-9457. ; 59, s. 56-65
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Tidskriftsartikel (refereegranskat)abstract
- The Clinical Global Impression scale (CGI) reflects the clinician's assessment of the disease impact on patient's global functioning. We assessed predictors of CGI scale rating in patients with obstructive sleep apnea (OSA).Consecutive patients with suspected OSA (n=7581) were identified in the European Sleep Apnea Database (ESADA). Anthropometrics, comorbidities, apnea severity obtained by polygraphy or polysomnography, and daytime sleepiness [Epworth Sleepiness Scale (ESS)] were assessed. The CGI 7-point scale was completed at the end of the diagnostic process (CGI-severity, ie, CGI-S) and, in a subpopulation, at treatment follow-up (CGI-Improvement).CGI-S was rated mild to moderate in 44% of patients. CGI rating at any given apnea intensity was worse in women than in men (p<0.01). Patients undergoing polygraphy (n=5075) were more frequently rated as severely ill compared to those studied with polysomnography (19.0% vs 13.0%, p<0.001). In patients aged ≤65 years, CGI scoring was generally better than in the elderly despite a similar degree of OSA (eg, 'normal, not ill' 24.2% vs 15.3%, p<0.01, respectively). Independent predictors of CGI rating included age, BMI, AHI, ESS, cardio-metabolic comorbidities, and diagnosis based on polygraphy. CGI-improvement rating (Beta=-0.406, p<0.01) was superior to sleep apnea severity or ESS-score (Beta=0.052 and-0.021, p=0.154 and 0.538 respectively) at baseline for prediction of good CPAP compliance at follow-up.CGI rating is confounded by gender, age class and the type of sleep diagnostic method. As OSA phenotypes differ, CGI may contribute as a clinical tool to reflect the significance of clinical disease.
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| 3. |
- Marklund, Marie, 1949-, et al.
(författare)
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Non-CPAP therapies in obstructive sleep apnoea : mandibular advancement device therapy
- 2012
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Ingår i: European Respiratory Journal. - : European Respiratory Society (ERS). - 0903-1936 .- 1399-3003. ; 39:5, s. 1241-1247
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Tidskriftsartikel (refereegranskat)abstract
- Mandibular advancement devices (MADs) represent the main non-continuous positive airway pressure (non-CPAP) therapy for patients with obstructive sleep apnoea (OSA). The aim of the European Respiratory Society Task Force was to review the evidence in favour of MAD therapy . Effects of tongue-retaining devices are not included in this report. Custom-made MADs reduce apnoea/hypopnoea index (AHI) and daytime sleepness compared with placebo devices. CPAP more effectively dIminishes AHI, while increasing data suggest fairly similar outcomes in relation to symptoms and cardiovascular health from these treatments. Patients often prefer MADs to CPAP. Milder cases and patients with a proven increase in upper airway size as a result of mandibular advancement are most likely to experience treatment success with MADs. A custom-made device titrated from an initial 50% of maximum mandibular advancement has been recommended. More research is needed to define the patients who will benefit from MAD treatment compared with CPAP, in terms of the effects on sleep—disordered breathing and on other diseases related to OSA. In conclusion, MADs are recommended for patients with mild to moderate OSA (Recommendation Level A) and for those who do not tolerate CPAP. The treatment must be followed up and the device adjusted or exchanged in relation to the outcome.
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| 4. |
- Marklund, Marie, et al.
(författare)
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Update on oral appliance therapy
- 2019
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Ingår i: European Respiratory Review. - : NLM (Medline). - 0905-9180 .- 1600-0617. ; 28:153
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Forskningsöversikt (refereegranskat)abstract
- Oral appliances are increasingly recommended for selected patients with obstructive sleep apnoea (OSA) and those who do not tolerate nor prefer continuous positive airway pressure. The most commonly used oral appliance advances the lower jaw during sleep, the so-called mandibular advancement device (MAD). Patients seek treatment because of disturbing snoring, daytime symptoms, apnoeas that disturb sleep and the longer term consequences with regard to cardiovascular risks. MADs reduce the apnoea-hypopnoea index, although to various degrees among patients. Effects on daytime sleepiness have been observed mainly among the more severe OSA patients. Blood pressure may be reduced in MAD-treated OSA patients. There is, however, uncertainty about which patients will respond to this therapy in terms of apnoea reductions, decreased sleepiness and other symptoms, and reduced risk for future impaired health. The occurrence of side-effects also remains difficult to predict at present. The majority of sleep apnoea patients suffer from various comorbidities in terms of cardiovascular diseases, type 2 diabetes and depression. The most recent findings indicate that phenotyping of patients, considering various aspects of this multifaceted disease, will shed more light on the indications for MADs in patients with nightly sleep breathing disturbances. This review summarises the most recent knowledge about MAD treatment.
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| 5. |
- Marrone, Oreste, et al.
(författare)
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Chronic kidney disease in European patients with obstructive sleep apnea: the ESADA cohort study
- 2016
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Ingår i: Journal of Sleep Research. - : Wiley. - 0962-1105 .- 1365-2869. ; 25, s. 739-745
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Tidskriftsartikel (refereegranskat)abstract
- © 2016 European Sleep Research Society The cross-sectional relationship of obstructive sleep apnea with moderate to severe chronic kidney disease, defined as an estimated glomerular filtration rate <60mLmin−1∙1.73m−2, was investigated in a large cohort of patients with suspected obstructive sleep apnea studied by nocturnal polysomnography or cardiorespiratory polygraphy. Data were obtained from the European Sleep Apnea Database, where information from unselected adult patients with suspected obstructive sleep apnea afferent to 26 European sleep centres had been prospectively collected. Both the Modification of Diet in Renal Disease and the Chronic Kidney Disease-Epidemiology Collaboration equations were used for the assessment of estimated glomerular filtration rate. The analysed sample included 7700 subjects, 71% male, aged 51.9±12.5years. Severe obstructive sleep apnea (apnea–hypopnea index ≥30) was found in 34% of subjects. The lowest nocturnal oxygen saturation was 81±10.2%. Chronic kidney disease prevalence in the whole sample was 8.7% or 6.1%, according to the Modification of Diet in Renal Disease or the Chronic Kidney Disease-Epidemiology Collaboration equations, respectively. Subjects with lower estimated glomerular filtration rate were older, more obese, more often female, had worse obstructive sleep apnea and more co-morbidities (P<0.001, each). With both equations, independent predictors of estimated glomerular filtration rate <60 were: chronic heart failure; female gender; systemic hypertension; older age; higher body mass index; and worse lowest nocturnal oxygen saturation. It was concluded that in obstructive sleep apnea, chronic kidney disease is largely predicted by co-morbidities and anthropometric characteristics. In addition, severe nocturnal hypoxaemia, even for only a small part of the night, may play an important role as a risk factor for kidney dysfunction.
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| 6. |
- Pepin, Jean-Louis, et al.
(författare)
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Long-Term Efficacy and Safety of Pitolisant for Residual Sleepiness Due to OSA
- 2024
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Ingår i: CHEST. - 0012-3692 .- 1931-3543. ; 165:3, s. 692-703
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In people with OSA, excessive daytime sleepiness is a prominent symptom and can persist despite adherence to CPAP, the first -line therapy for OSA. Pitolisant was effective in reducing daytime sleepiness in two 12-week randomized controlled trials (RCTs), one in patients adherent to CPAP (BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS [HAROSA 1]) and the other in patients refusing or not tolerating CPAP (BF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP [HAROSA 2]). RESEARCH QUESTION: Does the efficacy and safety of pitolisant persist when these patients take it long -term? STUDY DESIGN AND METHODS: All adults included in the HAROSA 1 and HAROSA 2 RCTs (both pitolisant and placebo arms) were offered pitolisant (up to 20 mg/d) after completion of the short -term double-anonymized phase (ie, from week 13) in an open -label cohort study. The primary efficacy outcome was the change in Epworth Sleepiness Scale score between baseline and week 52. Safety outcomes were treatment-emergent adverse event(s) (TEAE[s]), serious TEAEs, and special interest TEAEs. RESULTS: Out of 512 adults included in the two RCTs, 376 completed the 1 -year follow-up. The pooled mean difference in Epworth Sleepiness Scale score from baseline to 1 year for the intention-to-treat sample was -8.0 (95% CI, -8.3 to -7.5). The overall proportions of TEAEs, serious TEAEs, and TEAEs of special interest were 35.1%, 2.0%, and 11.1%, respectively, without any significant difference between patients in the initial pitolisant and placebo arms. No cardiovascular safety issues were reported. INTERPRETATION: Pitolisant is effective in reducing daytime sleepiness over 1 year in adults with OSA, with or without CPAP treatment. Taken for 1 year, it has a good safety profile (including cardiovascular).
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| 7. |
- Randerath, Winfried, et al.
(författare)
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Current and novel treatment options for obstructive sleep apnoea
- 2022
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Ingår i: ERJ Open Research. - : European Respiratory Society. - 2312-0541. ; 8:2
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Forskningsöversikt (refereegranskat)abstract
- Obstructive sleep apnoea is a challenging medical problem due to its prevalence, its impact on quality of life and performance in school and professionally, the implications for risk of accidents, and comorbidities and mortality. Current research has carved out a broad spectrum of clinical phenotypes and defined major pathophysiological components. These findings point to the concept of personalised therapy, oriented on both the distinct clinical presentation and the most relevant pathophysiology in the individual patient. This leads to questions of whether sufficient therapeutic options other than positive airway pressure (PAP) alone are available, for which patients they may be useful, if there are specific indications for single or combined treatment, and whether there is solid scientific evidence for recommendations. This review describes our knowledge on PAP and non-PAP therapies to address upper airway collapsibility, muscle responsiveness, arousability and respiratory drive. The spectrum is broad and heterogeneous, including technical and pharmaceutical options already in clinical use or at an advanced experimental stage. Although there is an obvious need for more research on single or combined therapies, the available data demonstrate the variety of effective options, which should replace the unidirectional focus on PAP therapy.
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| 8. |
- Randerath, Winfried, et al.
(författare)
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European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea
- 2021
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Ingår i: European Respiratory Review. - : ERS Publications. - 0905-9180 .- 1600-0617. ; 30:162
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Tidskriftsartikel (refereegranskat)abstract
- Treatment of obstructive sleep apnoea (OSA) in adults is evolving, as new therapies have been explored and introduced in clinical practice, while other approaches have been refined or reconsidered. In this European Respiratory Society (ERS) guideline on non-continuous positive airway pressure (CPAP) therapies for OSA, we present recommendations determined by a systematic review of the literature. It is an update of the 2011 ERS statement on non-CPAP therapies, advanced into a clinical guideline. A multidisciplinary group of experts, including pulmonary, surgical, dentistry and ear-nose-throat specialists, methodologists and patient representatives considered the most relevant clinical questions (for both clinicians and patients) relating to the management of OSA. Eight key clinical questions were generated and a systematic review was conducted to identify published randomised clinical trials that answered these questions. We used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to assess the quality of the evidence and the strength of recommendations. The resulting guideline addresses gastric bypass surgery, custom-made dual-block mandibular advancement devices, hypoglossal nerve stimulation, myofunctional therapy, maxillo-mandibular osteotomy, carbonic anhydrase inhibitors and positional therapy. These recommendations can be used to benchmark quality of care for people with OSA across Europe and to improve outcomes.
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| 9. |
- Vanderveken, Olivier M, et al.
(författare)
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Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea
- 2008
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Ingår i: American Journal of Respiratory and Critical Care Medicine. - New York : American Lung Association. - 1073-449X .- 1535-4970. ; 178:2, s. 197-202
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Tidskriftsartikel (refereegranskat)abstract
- Rationale: The efficacy of immediate adaptation of mandibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing (SDB) has been demonstrated in clinical studies. To date, there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices. Objectives: Our purpose was to compare the efficacy of both types of devices in patients with SDB. Methods: A randomized controlled cross-over trial, comprising 4 months of treatment with a thermoplastic and a custom-made device, with a 1-month washout interval. Measurements and Main Results: A total of 35 patients (29 males; age, 49 ± 9 yr; apnea–hypopnea index [AHI], 13 ± 11 events/h; body mass index, 28 ± 4 kg/m2) completed the protocol. AHI was only reduced with the custom-madedevice (P = 0.005). In addition, this device reduced snoring to a greater extent than the thermoplastic device. The success rate was higher with the custom-made device (60 vs. 31%; P = 0.02). One-third of the patients demonstrated compliance failure with the thermoplastic device, mainly because of insufficient overnight retention. Total failure rate with the thermoplastic device was 69%, whereas the majority (63%) of these were successfully treated with the custom-made device. At the end of the study, 82% of the patients preferred the custom-made device, and 9% had no preference (P < 0.0001). Conclusions: In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.
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