{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T03:22:40Z","timestamp":1777951360695,"version":"3.51.4"},"reference-count":14,"publisher":"Danish Medical Association","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Dan Med J"],"abstract":"<jats:p>INTRODUCTION. In-home non-invasive ventilation (NIV) is associated with prolonged life and improved quality of life in patients with hypoventilation due to amyotrophic lateral sclerosis (ALS). The initiation of NIV is scheduled for a 1-2-night hospital stay. Telemedicine enables remote monitoring and adjustment of respiratory treatment. These possibilities should be examined to improve patients\u2019 experiences and adherence to treatment while freeing up resources in the healthcare system. We hypothesise that outpatient initiation of NIV combined with close telemonitoring in patients with ALS is non-inferior to standard initiation of NIV in adherence to treatment.\n\nMETHODS. This is a randomised, controlled, non-inferiority study. A total of 46 patients with ALS scheduled for initiation of NIV are randomised to start NIV either as an outpatient combined with close telemonitoring or during hospitalisation for 1-2 nights. The primary outcome is NIV adherence after three months, measured as minutes per day for the past seven days. Secondary outcomes are patient satisfaction with NIV treatment and its initiation after three months, assessed on a 1-5 rating scale.\n\nCONCLUSIONS. The study is the first randomised, controlled study assessing the combination of outpatient initiation of NIV and close telemedical follow-up in patients with a progressive neuromuscular disease. The results may be applicable to other patient populations initiating NIV, e.g., patients with obesity hypoventilation syndrome.\n\nFUNDING. The study was supported by grants from ALS-fonden and Muskelsvindfonden.\n\nTRIAL REGISTRATION. NCT05829330.<\/jats:p>","DOI":"10.61409\/a09250733","type":"journal-article","created":{"date-parts":[[2026,3,31]],"date-time":"2026-03-31T12:11:01Z","timestamp":1774959061000},"page":"1-9","source":"Crossref","is-referenced-by-count":0,"title":["Outpatient versus inpatient initiation of home mechanical ventilation in patients with amyotrophic lateral sclerosis \u2013 a protocol for a randomised trial"],"prefix":"10.61409","author":[{"given":"Janne B\u00f8gh","family":"Stokholm","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simone Henrietta Lisa","family":"K\u00fcchen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirsten","family":"M\u00f8ller","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mona Ring","family":"G\u00e4tke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirsten","family":"Svenstrup","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne Kathrine","family":"Staehr-Rye","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"40208","published-online":{"date-parts":[[2026,3]]},"reference":[{"key":"ref0","doi-asserted-by":"publisher","unstructured":"Bourke SC, Tomlinson M, Williams TL, et al. Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial. Lancet Neurol. 2006;5(2):140-147. https:\/\/doi.org\/10.1016\/S1474-4422(05)70326-4","DOI":"10.1016\/S1474-4422(05)70326-4"},{"key":"ref1","doi-asserted-by":"publisher","unstructured":"Kleopa KA, Sherman M, Neal B, et al. Bipap improves survival and rate of pulmonary function decline in patients with ALS. J Neurol Sci. 1999;164(1):82-88. https:\/\/doi.org\/10.1016\/S0022-510X(99)00045-3","DOI":"10.1016\/S0022-510X(99)00045-3"},{"key":"ref2","doi-asserted-by":"publisher","unstructured":"St\u00e6hr-Rye AK, Irlind T\u00d8, Funderskov K, et al. Adherence to long-term non-invasive positive airway pressure therapy. Dan Med J. 2024;71(11):A04240290. https:\/\/doi.org\/10.61409\/A04240290","DOI":"10.61409\/A04240290"},{"key":"ref3","doi-asserted-by":"publisher","unstructured":"Shefner JM, Al-Chalabi A, Baker M, et al. A proposal for new diagnostic criteria for ALS. Clin Neurophysiol. 2020;131(8):1975-1978. https:\/\/doi.org\/10.1016\/j.clinph.2020.04.005","DOI":"10.1016\/j.clinph.2020.04.005"},{"key":"ref4","unstructured":"Dansk Selskab for Amyotrofisk Lateral Sclerose. Retningslinier for varetagelse af amyotrofisk lateral sclerose (ALS) og besl\u00e6gtede sygdomme i Danmark. 2nd ed. Dansk Selskab for Amyotrofisk Lateral Sclerose, 2024. Chapter 11.4. www.danskselskabforals.dk\/wp-content\/uploads\/2024\/05\/ALS_CARE_vs2.0_2024.pdf"},{"key":"ref5","doi-asserted-by":"publisher","unstructured":"McKim DA, Road J, Avendano M, et al. Home mechanical ventilation: a Canadian Thoracic Society clinical practice guideline. Can Respir J. 2011;18(4):197-215. https:\/\/doi.org\/10.1155\/2011\/139769","DOI":"10.1155\/2011\/139769"},{"key":"ref6","doi-asserted-by":"publisher","unstructured":"Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999;169(1-2):13-21. https:\/\/doi.org\/10.1016\/S0022-510X(99)00210-5","DOI":"10.1016\/S0022-510X(99)00210-5"},{"key":"ref7","doi-asserted-by":"publisher","unstructured":"Niven E, Newton J, Foley J, et al. Validation of the Edinburgh Cognitive and Behavioural Amyotrophic Lateral Sclerosis Screen (ECAS): a cognitive tool for motor disorders. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(3-4):172-179. https:\/\/doi.org\/10.3109\/21678421.2015.1030430","DOI":"10.3109\/21678421.2015.1030430"},{"key":"ref8","doi-asserted-by":"publisher","unstructured":"Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. 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