Provox Life HMEs for Pulmonary Rehabilitation in HME-Naïve Laryngectomy Patients: A Randomized Controlled Trial

OBJECTIVE: To evaluate whether Provox Life Heat and Moisture Exchangers (HMEs) and attachments enable HME-naïve laryngectomized patients to establish a 24-h HME routine, and whether the resulting effect on pulmonary symptoms is sustained over 9 months, compared with standard care. METHODS: In this prospective, randomized controlled trial, 79 HME-naïve patients post-total laryngectomy at two Brazilian centers were randomized to the Provox Life group (n = 41) or a control group without HMEs (n = 38). Data were collected at baseline and at 3, 6, and 9 months. The primary endpoint was the Cough Symptoms (COUS) domain of the validated Cough and Sputum Assessment Questionnaire (CASA-Q). Secondary endpoints included other CASA-Q domains, forced expectorations, involuntary coughs, sleep quality (JSEQ), quality of life (EQ-5D-5L), shortness of breath, skin integrity, pulmonary complications, and patient satisfaction. RESULTS: HME adherence was near-continuous (mean 23.3-23.9 h/day). All four CASA-Q domains (COUS, COUI, SPUS, SPUI) improved significantly from baseline in the Provox Life group (all p ≤ 0.001 at 9 months), with changes exceeding published minimal clinically important differences; controls remained stable except for transient sputum-domain gains at T2. At 9 months, forced expectorations were significantly lower in the Provox Life group versus controls (3.3 ± 2.2 vs. 6.6 ± 6.1 per 24 h; p = 0.023). Sleep quality (JSEQ) improved significantly with Provox Life (p = 0.013), but not in controls. The EQ-5D-5L index improved at 3 and 6 months, pulmonary complications were descriptively fewer, and 89.7% rated their experience "very good". Skin irritation was low and comparable between groups. No device-related serious adverse events occurred. CONCLUSION: In HME-naïve patients after total laryngectomy, Provox Life enables near-continuous 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. LEVEL OF EVIDENCE: 1b Trial Registration: ClinicalTrials.gov identifier: NCT06084611.