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      BAY 2253651 for the treatment of obstructive sleep apnoea: a multicentre, double-blind, randomised controlled trial (SANDMAN)

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          Abstract

          For obstructive sleep apnoea (OSA), few mechanical treatment options are available and no pharmacotherapy is approved [1–3]. However, safe and efficacious pharmacotherapy would have substantial appeal for many people with OSA.

          Abstract

          BAY 2253651 is a nasally applied genioglossus muscle activator via pharyngeal mucosal receptor stimulation (potassium channel blocker) aimed to treat obstructive sleep apnoea. Although well-tolerated and safe, there was no significant therapeutic effect. https://bit.ly/3zDbyia

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          Most cited references15

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          CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea.

          Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain.
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            Adherence to continuous positive airway pressure therapy: the challenge to effective treatment.

            Despite the high efficacy of continuous positive airway pressure (CPAP) to reverse upper airway obstruction in sleep apnea, treatment effectiveness is limited by variable adherence to prescribed therapy. When adherence is defined as greater than 4 hours of nightly use, 46 to 83% of patients with obstructive sleep apnea have been reported to be nonadherent to treatment. Evidence suggests that use of CPAP for longer than 6 hours decreases sleepiness, improves daily functioning, and restores memory to normal levels. The decision to embrace CPAP occurs during the first few days of treatment. Although many strategies in patient interface with CPAP or machine modality are marketed to improve CPAP usage, there are few data to support this. No single factor has been consistently identified as predictive of adherence. Patient perception of symptoms and improvement in sleepiness and daily functioning may be more important in determining patterns of use than physiologic aspects of disease severity. Emerging data suggest that various behavioral interventions may be effective in improving CPAP adherence.
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              Clinical predictors of the respiratory arousal threshold in patients with obstructive sleep apnea.

              A low respiratory arousal threshold (ArTH) is one of several traits involved in obstructive sleep apnea pathogenesis and may be a therapeutic target; however, there is no simple way to identify patients without invasive measurements.
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                Author and article information

                Journal
                Eur Respir J
                Eur Respir J
                ERJ
                erj
                The European Respiratory Journal
                European Respiratory Society
                0903-1936
                1399-3003
                November 2021
                18 November 2021
                : 58
                : 5
                : 2101937
                Affiliations
                [1 ]Sleep Disorders Center and Pulmonary Division, University Hospital Zurich, Zurich, Switzerland
                [2 ]National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
                [3 ]Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
                [4 ]Clinical Experimentation, Pharma Research Center, Bayer Pharma, Wuppertal, Germany
                [5 ]Clinical Operations, Pharma Research Center, Bayer Pharma, Wuppertal, Germany
                [6 ]Global Development, Bayer Healthcare Company, Beijing, China
                [7 ]Sleep Research Group, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, Australia
                [8 ]Dept of Respiratory and Sleep Medicine, Centre for Sleep Health and Research, Royal North Shore Hospital, Sydney, Australia
                [9 ]Newcastle Regional Sleep Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
                [10 ]Neuroscience Research Australia (NeuRA), Sydney, Australia
                [11 ]Adelaide Institute for Sleep Health, Flinders health and Medical Research Institute, College of Medicine and Public Health, Flinders University, Adelaide, Australia
                [12 ]Zurich Center for Interdisciplinary Sleep Research, University of Zurich, Zurich, Switzerland
                Author notes
                Author information
                https://orcid.org/0000-0002-9017-6143
                https://orcid.org/0000-0002-9156-0534
                https://orcid.org/0000-0003-3503-2363
                Article
                ERJ-01937-2021
                10.1183/13993003.01937-2021
                8607905
                34531274
                fa3543af-6e95-41d6-9c93-3abf79ee4e74
                Copyright ©The authors 2021.

                This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For reproduction rights and permissions contact permissions@ersnet.org

                History
                : 02 July 2021
                : 23 August 2021
                Funding
                Funded by: Bayer HealthCare, doi 10.13039/501100000801;
                Categories
                Agora
                Research Letters

                Respiratory medicine
                Respiratory medicine

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