{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T12:57:02Z","timestamp":1790513822830,"version":"4.1.0"},"reference-count":16,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T00:00:00Z","timestamp":1790467200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T00:00:00Z","timestamp":1790467200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Laryngoscope Investig Oto"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate whether Provox Life Heat and Moisture Exchangers (HMEs) and attachments enable HME\u2010na\u00efve laryngectomized patients to establish a 24\u2010h HME routine, and whether the resulting effect on pulmonary symptoms is sustained over 9\u2009months, compared with standard care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this prospective, randomized controlled trial, 79 HME\u2010na\u00efve patients post\u2010total laryngectomy at two Brazilian centers were randomized to the Provox Life group (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200941) or a control group without HMEs (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200938). Data were collected at baseline and at 3, 6, and 9\u2009months. The primary endpoint was the Cough Symptoms (COUS) domain of the validated Cough and Sputum Assessment Questionnaire (CASA\u2010Q). Secondary endpoints included other CASA\u2010Q domains, forced expectorations, involuntary coughs, sleep quality (JSEQ), quality of life (EQ\u20105D\u20105L), shortness of breath, skin integrity, pulmonary complications, and patient satisfaction.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      HME adherence was near\u2010continuous (mean 23.3\u201323.9\u2009h\/day). All four CASA\u2010Q domains (COUS, COUI, SPUS, SPUI) improved significantly from baseline in the Provox Life group (all\n                      <jats:italic>p<\/jats:italic>\n                      \u2009\u2264\u20090.001 at 9\u2009months), with changes exceeding published minimal clinically important differences; controls remained stable except for transient sputum\u2010domain gains at T2. At 9\u2009months, forced expectorations were significantly lower in the Provox Life group versus controls (3.3\u2009\u00b1\u20092.2 vs. 6.6\u2009\u00b1\u20096.1 per 24\u2009h;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.023). Sleep quality (JSEQ) improved significantly with Provox Life (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.013), but not in controls. The EQ\u20105D\u20105L index improved at 3 and 6\u2009months, pulmonary complications were descriptively fewer, and 89.7% rated their experience \u201cvery good\u201d. Skin irritation was low and comparable between groups. No device\u2010related serious adverse events occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In HME\u2010na\u00efve patients after total laryngectomy, Provox Life enables near\u2010continuous HME use and is associated with clinically meaningful improvements in pulmonary symptom burden, sputum management, and sleep quality. Skin tolerability is comparable to standard care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence<\/jats:title>\n                    <jats:p>1b<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      ClinicalTrials.gov identifier: NCT06084611.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/lio2.70576","type":"journal-article","created":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T12:54:17Z","timestamp":1790513657000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Provox Life\n                    <scp>HMEs<\/scp>\n                    for Pulmonary Rehabilitation in\n                    <scp>HME<\/scp>\n                    \u2010Na\u00efve Laryngectomy Patients: A Randomized Controlled Trial"],"prefix":"10.1002","volume":"11","author":[{"given":"Rafael","family":"De Cicco","sequence":"first","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5916-9730","authenticated-orcid":false,"given":"Rafael Pereira","family":"de Souza","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carla Gon\u00e7alves Soares","family":"Moreira","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra Lopez","family":"Calcines","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor Bandini","family":"Vieira","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela Maria Santos Serrano","family":"Marquezin","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Santa Casa de S\u00e3o Paulo  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1945-1472","authenticated-orcid":false,"given":"Marianne Yumi","family":"Nakai","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Santa Casa de S\u00e3o Paulo  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelo Benedito","family":"Menezes","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Santa Casa de S\u00e3o Paulo  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tabata Briaunys","family":"Milan","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco Ara\u00fajo","family":"Dias","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Surgery Instituto de C\u00e2ncer Dr. Arnaldo (ICAVC)  S\u00e3o Paulo SP Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,27]]},"reference":[{"issue":"6","key":"e_1_2_10_2_1","doi-asserted-by":"crossref","first-page":"929","DOI":"10.1177\/01945998221086200","article-title":"Optimizing Pulmonary Outcomes After Total Laryngectomy: Crossover Study on New Heat and Moisture Exchangers","volume":"167","author":"Longobardi Y.","year":"2022","journal-title":"Otolaryngology and Head and Neck Surgery"},{"issue":"4","key":"e_1_2_10_3_1","doi-asserted-by":"crossref","first-page":"939","DOI":"10.1002\/hed.27323","article-title":"Postlaryngectomy Pulmonary and Related Symptom Changes Following Adoption of an Optimal Day\u2010and\u2010Night Heat and Moisture Exchanger (HME) Regimen","volume":"45","author":"Ward E. 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