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The primary aim of this multicentre trial was to evaluate HFOT in addition to LFOT, compared with regular LFOT in people with CRF due to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Registry-based randomised controlled trial (R-RCT) of people on LFOT for CRF due to COPD (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009270) and ILD (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200940), at ten Swedish secondary care centres within the Swedish Register for Respiratory Failure (Swedevox). People with ongoing LFOT are randomised in a 1:1 ratio to standard treatment with LFOT (control) or LFOT with added HFOT during nighttime and at the patient\u2019s discretion daytime (intervention). HFOT is provided using the ResMed Lumis HFT system and the AcuCare HFNC Cannula. Primary outcome is time to first hospitalisation or death up to 1 year in people with COPD. Secondary outcomes include symptoms, health-related outcomes (HRQL), health-economics, adverse events, and to explore the effects of HFOT in people with CRF due to ILD. Outcome data will be obtained from national registries and from patient questionnaires at 3 and 12\u00a0months.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This R-RCT will combine the advantages of a prospective randomised trial and large clinical national registries to improve the evidence-based use of long-term oxygen therapy. Recruitment started in June 2024 and is ongoing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov, ID: NCT06247397. Registered 2024\u201302\u201307.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-026-09488-8","type":"journal-article","created":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T02:43:51Z","timestamp":1770173031000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Effect of HIgh-Flow Therapy in Long-Term Oxygen Therapy (HILOT): study protocol for a multicentre, registry-based, randomised clinical trial"],"prefix":"10.1186","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1926-8464","authenticated-orcid":false,"given":"Josefin","family":"Sundh","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirjam","family":"Ljunggren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Palm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Lindberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florent","family":"Lavergne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulla M\u00f8ller","family":"Weinreich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zainab","family":"Ahmadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magnus","family":"Ekstr\u00f6m","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the HILOT Collaboration Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Blomberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pia","family":"Ghosh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taivo","family":"Kipper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ozran","family":"Kricka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo","family":"Pedersen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Andersson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"Einarsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanan","family":"Tanash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,4]]},"reference":[{"key":"9488_CR1","doi-asserted-by":"publisher","first-page":"391","DOI":"10.7326\/0003-4819-93-3-391","volume":"93","author":"Nocturnal Oxygen Therapy Trial Group","year":"1980","unstructured":"Nocturnal Oxygen Therapy Trial Group. 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Accessed 02\u201302\u20132023."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-026-09488-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-026-09488-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-026-09488-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T13:07:47Z","timestamp":1771852067000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13063-026-09488-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,4]]},"references-count":42,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["9488"],"URL":"https:\/\/doi.org\/10.1186\/s13063-026-09488-8","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,4]]},"assertion":[{"value":"14 June 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 January 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 February 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study will be conducted in accordance with the protocol and ethical principles of the Declaration of Helsinki as adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964 and subsequent versions. The study was approved by the Swedish Ethical Review Authority the 12th of December 2023 (Dnr 2023\u201307085-01), with amendment on the 22nd of June 2024 (Dnr 2024\u201304041-02).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare no competing interests in relation to this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"177"}}