{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T11:09:25Z","timestamp":1779880165205,"version":"3.53.1"},"reference-count":25,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T00:00:00Z","timestamp":1750723200000},"content-version":"unspecified","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"NIH\/NHLBI","award":["R33 HL162839"],"award-info":[{"award-number":["R33 HL162839"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,5,27]]},"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:sec>\n<jats:title>Introduction<\/jats:title>\n<jats:p>Obstructive sleep apnoea (OSA) affects 15% of the paediatric population, including 5590% of children with Down syndrome (DS), and has been associated with negative effects on neurocognitive development, cardiovascular health, immune development and quality of life. In-lab attended polysomnography (PSG) is currently the gold standard for the diagnosis of OSA in children, but it poses challenges due to the burden on families and limited testing facilities. Home sleep apnoea testing (HSAT), an unattended sleep test done at home, is an accepted alternative for adults but lacks sufficient evidence to be used clinically for the evaluation of OSA in children. HSAT may be especially beneficial for children with DS or others with sensory issues or those who struggle with sleeping in a laboratory setting overnight.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods and analysis<\/jats:title>\n<jats:p>This single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS. The trial will enrol 317 children 512 years old, including approximately 100 with DS. The primary outcome is the diagnostic accuracy of HSAT compared with PSG for OSA evaluated through ROC. Secondary outcomes include the agreement between HSAT and PSG for therapeutic decision-making and comparison of preference and acceptability of HSAT versus PSG. This trial seeks to evaluate HSAT as an alternative diagnostic tool for paediatric OSA, potentially expanding testing options for clinicians and families.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Ethics and dissemination<\/jats:title>\n<jats:p>This study has been approved by the Institutional Review Board at Childrens Hospital of Philadelphia (#210 19 533). Informed consent will be obtained from all participants, and no identifiable data will be reported.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Trial registration number<\/jats:title>\n<jats:p>\n<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial \" xlink:href=\"NCT05382754\">NCT05382754<\/jats:ext-link>\n.\n<\/jats:p>\n<\/jats:sec>","DOI":"10.1136\/bmjopen-2025-103315","type":"journal-article","created":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T07:49:08Z","timestamp":1750924148000},"page":"e103315","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Randomised trial of home sleep apnoea testing compared to in-lab polysomnography for the evaluation of obstructive sleep apnoea in children: rationale and study protocol"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct05382754","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05382754","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Yaelis D","family":"Roman Rosado","sequence":"first","affiliation":[{"name":"Division of Pulmonary and Sleep Medicine, The Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahalakshmi","family":"Somayaji","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Sleep Medicine, The Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darko","family":"Stefanovski","sequence":"additional","affiliation":[{"name":"University of Pennsylvania School of Veterinary Medicine, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0723-7743","authenticated-orcid":false,"given":"Eberechukwu A","family":"Uwah","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Sleep Medicine, The Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Ward","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Sleep Medicine, The Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ignacio E","family":"Tapia","sequence":"additional","affiliation":[{"name":"University of Miami, Coral Gables, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anjalee","family":"Galion","sequence":"additional","affiliation":[{"name":"University of California Irvine, Irvine, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lourdes M","family":"DelRosso","sequence":"additional","affiliation":[{"name":"University of California San Francisco, San Francisco, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sally L","family":"Davidson Ward","sequence":"additional","affiliation":[{"name":"Childrens Hospital Los Angeles, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5761-6373","authenticated-orcid":false,"given":"Christopher M","family":"Cielo","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Sleep Medicine, The Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, USA"},{"name":"Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,6,24]]},"reference":[{"key":"2025071022171579000_15.6.e103315.1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.159.8.775"},{"key":"2025071022171579000_15.6.e103315.2","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/32.6.731"},{"key":"2025071022171579000_15.6.e103315.3","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2010.134858"},{"key":"2025071022171579000_15.6.e103315.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215881"},{"key":"2025071022171579000_15.6.e103315.5","doi-asserted-by":"publisher","DOI":"10.5665\/sleep.5554"},{"key":"2025071022171579000_15.6.e103315.6","doi-asserted-by":"crossref","first-page":"899","DOI":"10.5664\/jcsm.8358","article-title":"Children with Down syndrome and mild OSA: treatment with medication versus observation","volume":"16","author":"Yu","year":"2020","journal-title":"J Clin Sleep Med"},{"key":"2025071022171579000_15.6.e103315.7","doi-asserted-by":"publisher","DOI":"10.2147\/nss.s154723"},{"key":"2025071022171579000_15.6.e103315.8","unstructured":"Troester MM , Quan SF , Richard B , et al . 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