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Summary Background A high incidence of erectile dysfunction (ED) among patients with obstructive sleep apnoea syndrome (OSAS) has been reported, with a strong correlation between obstructive sleep apnoea, ED, and quality of life (QOL), and it has been estimated that 10–60% of patients with OSAS suffer from ED. In this prospective randomised controlled trial, we investigated 82 men with ED consecutively who were referred to the outpatient clinic for sleep disorders and had severe OSAS (AHI> 30 events/h) without any other comorbidities as a possible cause of ED. The aim of this study was to evaluate and compare the efficacy of sildenafil vs. continuous positive airway pressure (CPAP) in men with ED and severe OSAS. Methods Eighty‐two patients were randomised to two main treatment groups: group 1 patients (n = 41) were treated with 100‐mg sildenafil 1 h before sexual intercourse without CPAP, and group 2 patients (n = 41 men) were treated with only nasal CPAP during night time sleep. Both groups were evaluated with the same questionnaires (International Index of Erectile Function‐EF domain; Sex Encounter Profile; Erectile Dysfunction Inventory Treatment Satisfaction) 12 weeks after treatment. Results In patients receiving sildenafil treatment, 58.2% of those who attempted sexual intercourses were successful compared to 30.4% in the CPAP group. The mean number of successful attempts per week was significantly higher in the sildenafil group compared with the CPAP group (2.9 vs. 1.7, respectively; p < 0.0001). The mean IIEF‐EF domain scores were significantly higher in the sildenafil group compared with the CPAP group (p < 0.0001). The overall satisfaction rate was 68% with sildenafil treatment and 29% with CPAP treatment. Conclusions This study confirms that severe OSAS is strongly associated with erectile dysfunction. CPAP and sildenafil (100 mg) are safe and effective therapies for OSAS‐related ED patients. In the present study sildenafil was more effective than CPAP in treating ED associated with OSAS, as indicated by a significantly higher rate of successful attempts at intercourse and higher IIEF‐EF domain scores. Our study, to date, is the only that has investigated sildenafil in patients with severe OSAS.

Sleep Apnea is highly prevalent and may contribute to insulin resistance in patients with acromegaly. The primary aim of this study was to assess the impact of sleep apnea treatment with a continuous positive air pressure (CPAP) device on insulin resistance evaluated by hyperinsulinemic euglycemic clamp (HEC). A prospective, randomized, open label, placebo-controlled, crossover study was performed at a tertiary outpatient pituitary center. Twelve acromegalic subjects on somatostatin analogs (SA) with a recent diagnosis of moderate to severe sleep apnea were randomized to CPAP therapy or to nasal dilator adhesive (NDA) with placebo effect for 3 months and then crossed over for another 3 months period without washout. Assessment of HEC, mathematical insulin resistance indexes (HOMA, HOMA2 and QUICKI), GH, IGF-1, HbA 1c and free fat acids were performed. A significant reduction on insulin resistance was demonstrated by HEC at the end of the study in patients on CPAP (HEC, pre- and post-CPAP: 4.27 vs. 6.10 mg/Kg/min, P  = 0.032). This reduction was not observed in NDA group (HEC, pre- and post-adhesive: 5.53 vs. 5.19 mg/Kg/min, P  = 0.455). There was no significant difference on HbA 1c or on peripheral insulin resistance indexes in both treatments. CPAP promoted a significant increase on peripheral insulin sensitivity in acromegalic patients with moderate to severe sleep apnea on SA use. Our results support the concept that sleep apnea plays an important role on glucose metabolism. Insulin resistance indexes were unable to detect this finding.

Abstract Study Objectives Neurocognitive impairments in comorbid insomnia and sleep apnea (COMISA) are not well documented. We explored neurocognitive functioning and treatment effects in individuals with COMISA as an ancillary study to a randomized clinical trial. Methods Participants with COMISA (n = 45; 51.1% female; mean age = 52.07 ± 13.29 years), from a 3-arm randomized clinical trial combining cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) concurrently (CBT-I+PAP) or sequentially, completed neurocognitive testing at baseline, and post-treatment. Using Bayesian linear mixed models, we estimated effects of CBT-I, PAP, or CBT-I+PAP, compared to baseline, and CBT-I+PAP compared to PAP on 12 metrics across five cognitive domains. Results This COMISA sample had worse neurocognitive performance at baseline than reported for insomnia, sleep apnea, and controls in the literature, though short-term memory and psychomotor speed performance appears intact. When comparing PAP to baseline, performance on all measures was better after treatment. Performance after CBT-I was worse compared to baseline, and only performance in attention/vigilance, executive functioning via Stroop interference and verbal memory was better with moderate–high effect sizes and moderate probability of superiority (61–83). Comparisons of CBT-I+PAP to baseline generated results similar to PAP and comparing CBT-I+PAP to PAP revealed superior performance in only attention/vigilance via psychomotor vigilance task lapses and verbal memory for PAP. Conclusions Treatment combinations involving CBT-I were associated with poorer neurocognitive performance. These potentially temporary effects may stem from sleep restriction, a component of CBT-I often accompanied by initially reduced total sleep time. Future studies should examine long-term effects of individual and combined COMISA treatment pathways to inform treatment recommendations. Clinical trial This was an ancillary study from a clinical trial (Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS), which was preregistered at www.clinicaltrials.gov (NCT01785303)). Graphical abstract Graphical Abstract This figure was created using www.canva.com

Few patients with amyotrophic lateral sclerosis currently receive non-invasive ventilation (NIV), reflecting clinical uncertainty about the role of this intervention. We aimed to assess the effect of NIV on quality of life and survival in amyotrophic lateral sclerosis in a randomised controlled trial. 92 of 102 eligible patients participated. They were assessed every 2 months and randomly assigned to NIV (n=22) or standard care (n=19) when they developed either orthopnoea with maximum inspiratory pressure less than 60% of that predicted or symptomatic hypercapnia. Primary validated quality-of-life outcome measures were the short form 36 mental component summary (MCS) and the sleep apnoea quality-of-life index symptoms domain (sym). Both time maintained above 75% of baseline (T iMCS and T isym) and mean improvement (μMCS and μsym) were measured. NIV improved T iMCS, T isym, μMCS, μsym, and survival in all patients and in the subgroup with better bulbar function (n=20). This subgroup showed improvement in several measures of quality of life and a median survival benefit of 205 days (p=0·006) with maintained quality of life for most of this period. NIV improved some quality-of-life indices in those with poor bulbar function, including μsym (p=0·018), but conferred no survival benefit. In patients with amyotrophic lateral sclerosis without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy. In patients with severe bulbar impairment, NIV improves sleep-related symptoms, but is unlikely to confer a large survival advantage.

Background Oral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report. Methods In this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0±11.9/h; age 47±10 y; BMI 26.6±4.0 kg/m2; men/women: 31/20). Patients were unaware of the purpose of the study. Results No microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6±1.3 h per day with a regular OA users’ rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%. Conclusions The results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.

Backgrounds To explain the excess cardiovascular mortality observed in the SERVE-HF study, it was hypothesized that the high-pressure ASV default settings used lead to inappropriate ventilation, cascading negative consequences (i.e. not only pro-arrythmogenic effects through metabolic/electrolyte abnormalities, but also lower cardiac output). The aims of this study are: i) to describe ASV-settings for long-term ASV-populations in real-life conditions; ii) to describe the associated minute-ventilations (MV) and therapeutic pressures for servo-controlled-flow versus servo-controlled-volume devices (ASV-F Philips®-devices versus ASV-V ResMed®-devices). Methods The OTRLASV-study is a cross-sectional, 5-centre study including patients who underwent ASV-treatment for at least 1 year. The eight participating clinicians were free to adjust ASV settings, which were compared among i) initial diagnosed sleep-disordered-breathing (SBD) groups (Obstructive-Sleep-Apnea (OSA), Central-Sleep-Apnea (CSA), Treatment-Emergent-Central-Sleep-Apnea (TECSA)), and ii) unsupervised groups ( k -means clusters). To generate these clusters, baseline and follow-up variables were used (age, sex, body mass index (BMI), initial diagnosed Obstructive-Apnea-Index, initial diagnosed Central-Apnea-Index, Continuous-Positive-Airway-Pressure used before ASV treatment, presence of cardiopathy, and presence of a reduced left-ventricular-ejection-fraction (LVEF)). ASV-data were collected using the manufacturer’s software for 6 months. Results One hundred seventy-seven patients (87.57% male) were analysed with a median (IQ 25–75 ) initial Apnea-Hypopnea-Index of 50 (38–62)/h, an ASV-treatment duration of 2.88 (1.76–4.96) years, 61.58% treated with an ASV-V. SDB groups did not differ in ASV settings, MV or therapeutic pressures. In contrast, the five generated k -means clusters did (generally described as follows: (C1) male-TECSA-cardiopathy, (C2) male-mostly-CSA-cardiopathy, (C3) male-mostly-TECSA-no cardiopathy, (C4) female-mostly-elevated BMI-TECSA-cardiopathy, (C5) male-mostly-OSA-low-LVEF). Of note, the male-mostly-OSA-low-LVEF-cluster-5 had significantly lower fixed end-expiratory-airway-pressure (EPAP) settings versus C1 ( p  = 0.029) and C4 ( p  = 0.007). Auto-EPAP usage was higher in the male-mostly-TECSA-no cardiopathy-cluster-3 versus C1 ( p  = 0.006) and C2 ( p  < 0.001). MV differences between ASV-F ( p  = 0.002) and ASV-V ( p  < 0.001) were not homogenously distributed across clusters, suggesting specific cluster and ASV-algorithm interactions. Individual ASV-data suggest that the hyperventilation risk is not related to the cluster nor the ASV-monitoring type. Conclusions Real-life ASV settings are associated with combinations of baseline and follow-up variables wherein cardiological variables remain clinically meaningful. At the patient level, a hyperventilation risk exists regardless of cluster or ASV-monitoring type, spotlighting a future role of MV-telemonitoring in the interest of patient-safety. Trial registration The OTRLASV study was registered on ClinicalTrials.gov (Identifier: NCT02429986 ). 1 April 2015.

RationaleHighly prevalent and severe sleep-disordered breathing caused by acute cervical spinal cord injury (quadriplegia) is associated with neurocognitive dysfunction and sleepiness and is likely to impair rehabilitation.ObjectiveTo determine whether 3 months of autotitrating CPAP would improve neurocognitive function, sleepiness, quality of life, anxiety and depression more than usual care in acute quadriplegia.Methods and measurementsMultinational, randomised controlled trial (11 centres) from July 2009 to October 2015. The primary outcome was neurocognitive (attention and information processing as measure with the Paced Auditory Serial Addition Task). Daytime sleepiness (Karolinska Sleepiness Scale) was a priori identified as the most important secondary outcome.Main results1810 incident cases were screened. 332 underwent full, portable polysomnography, 273 of whom had an apnoea hypopnoea index greater than 10. 160 tolerated at least 4 hours of CPAP during a 3-day run-in and were randomised. 149 participants (134 men, age 46±34 years, 81±57 days postinjury) completed the trial. CPAP use averaged 2.9±2.3 hours per night with 21% fully ‘adherent’ (at least 4 hours use on 5 days per week). Intention-to-treat analyses revealed no significant differences between groups in the Paced Auditory Serial Addition Task (mean improvement of 2.28, 95% CI −7.09 to 11.6; p=0.63). Controlling for premorbid intelligence, age and obstructive sleep apnoea severity (group effect −1.15, 95% CI −10 to 7.7) did not alter this finding. Sleepiness was significantly improved by CPAP on intention-to-treat analysis (mean difference −1.26, 95% CI −2.2 to –0.32; p=0.01).ConclusionCPAP did not improve Paced Auditory Serial Addition Task scores but significantly reduced sleepiness after acute quadriplegia.Trial registration numberACTRN12605000799651.

Abstract Study objectives: Our aim was to evaluate the circadian rhythm of distal skin temperature (DST) in sleep-disordered breathing (SDB), its relation to excessive daytime sleepiness and the effect of continuous positive airway pressure (CPAP) on DST. Methods: Eighty SDB patients (53.1 ± 1.2 years old, 27.6% women) and 67 healthy participants (52.3 ± 1.6 years old, 26.9% women) wore a temperature data logger for 1 week. On the last day of that week, SDB patients underwent a polysomnography followed by a Maintenance of Wakefulness Test (MWT), Multiple Sleep Latency Test, and Sustained Attention to Response Task protocol to objectively quantify daytime sleepiness. A subset of 21 moderate to severe SDB patients were treated with CPAP during at least 3 months and revaluated with the same procedure. A nonparametric analysis was performed to characterize DST to assess differences between groups and associations among DST, polysomnography, and daytime sleepiness measures. Results: SDB patients showed an unstable, fragmented, flattened, phase-advanced, and less robust DST rhythm as compared to healthy participants. The more severe the SDB, the worse the DST pattern was, as indicated by the correlation coefficient. Sleepiness, according to MWT sleep latencies, was also associated with the higher fragmentation, lower amplitude, and less robustness of the DST rhythm. Treatment with CPAP improved DST pattern regularity and robustness. Conclusion: DST is altered in SDB, exhibiting a direct relationship to the severity of this condition, and improves with CPAP treatment. DST independently correlates with sleepiness, thus, its measurement may contribute to the understanding of the pathophysiology of sleepiness in these patients.

BackgroundSleep disordered breathing is a chronic condition often requiring patient commitment to positive airway pressure (PAP) therapy. Understanding the lived experience of PAP therapy users is crucial for clinicians to support successful treatment and identify research priorities. There is a lack of evidence in this area, and published data predominantly explore the negative experiences of PAP. This study aims to explore the lived experiences of patients using PAP therapy.Methods and analysisThis study employs a phenomenological approach, appropriate for researching human experiences where there is little existing research. Heideggerian theory underpins the research, recognising that the researcher’s beliefs influence meaning, allowing for rich analysis of the lived experience.Participants will be recruited from a randomised controlled trial investigating the medium-term clinical impact of customised interfaces for patients requiring PAP therapy. Purposive sampling will be used to seek representation from various demographics, with a maximum of 30 participants.Data collection will be via 1:1 semistructured interviews. Data will be analysed using Braun and Clarke’s six-phase reflexive thematic analysis. Data will be analysed inductively through an interpretivism lens. Data will be managed with computer-assisted qualitative data analysis software.Ethics and disseminationThis protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, the study webpage, infographics, animations, social media and healthcare awards. Tracy’s eight ‘big tent’ criteria for excellent qualitative research are comprehensive and encompassing, and this protocol has aimed to meet the criteria. The Consolidated Criteria for Reporting Qualitative Research has also been used. The findings of this study will contribute to a more holistic understanding of the lived experience of PAP therapy users, informing clinical practice and future research.Trial registration numberISRCTN74082423.

IntroductionSpinal cord injury (SCI) has been linked to increased frequencies of sleep-related breathing disorders (SRBDs) (≤50% after paraplegia and ≤90% following tetraplegia). However, SRBDs have been under-recognised and undertreated among individuals with SCI. The OPTIMISE SCI (Outcomes Post Treatment: Impact on Motor Impairment of Sleep Efficiency in SCI) is an ongoing phase 3 clinical trial focused on the effects of the early use of continuous positive airway pressure (CPAP) therapy to treat individuals with moderate-to-severe SRBDs in the acute/subacute stage after SCI.Methods and analysisA total of 44 participants with SCI who are newly diagnosed with moderate-to-severe SRBD are randomised into early CPAP therapy (initiated within the first 8 weeks postinjury) versus delayed CPAP therapy (initiated at 6 months postinjury). Participants with no/mild SRBDs are included in the control group (n=22). Primary outcome measures include neurological and functional recovery after SCI.Ethics and disseminationThe protocol for this randomised clinical trial (RCT) raised an interesting discussion with our research ethics board about delaying CPAP therapy by 3 months when a participant is diagnosed with moderate-to-severe SRBD. Given that the current standard of care does not include screening for SRBDs in individuals who are admitted for spinal cord rehabilitation, most individuals are screened for SRBDs during the chronic stage post-SCI, which represents a greater delay in the diagnosis and treatment of SRBDs in this population. Because the potential impact of the OPTIMISE SCI trial on the current standard of care outweighs the risk of delaying CPAP therapy by 3 months, this trial protocol was approved. The dissemination plan includes presentations at scientific meetings and publication of the results in a peer-reviewed scientific journal.Trial registration numberClinicalTrials.gov (NCT05473689).