A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation

L. Lansaat, B.J. de Kleijn, F.J.M. Hilgers, B.F.A.M. van der Laan, M.W.M. van den Brekel

Research output: Contribution to JournalArticleAcademicpeer-review

Abstract

Evaluation of short- and long-term clinical feasibility and exploration of limitations and advantages of a new automatic speaking valve (ASV) for laryngectomized patients with integrated HME, the Provox FreeHands FlexiVoice (FlexiVoice). This ASV not only enables automatic, but also manual closure of the valve. A multicenter, prospective clinical study in 40 laryngectomized patients was conducted. Participants were asked to use the FlexiVoice for 26 weeks. The primary outcome measure was long-term compliance. Secondary outcome measures were: patient preference, hours of FlexiVoice use, device life of adhesive, voice and speech quality, and quality of life. After 26 weeks, 15 patients (37.5 %) were using the FlexiVoice on a daily basis, for a mean of 12.64 h/day (SD ± 5.03). Ten patients (25 %) were using the device on a non-daily basis, for a mean of 3.76 h/day (SD ± 2.07). The remaining 15 patients (37.5 %) discontinued using the FlexiVoice. Sixty percent of the 25 long-term users applied both automatic and manual closure of the valve. Unpredictable fixation of the adhesive was the main reason for discontinuing or not using the FlexiVoice on a daily basis. Overall, 18 patients (45 %) preferred the FlexiVoice, 16 patients (40 %) their usual HME, 3 patients (7.5 %) their usual ASV, 1 patient (2.5 %) preferred no device at all, and in 2 patients preference was not recorded. The minor technical issues identified could be corrected. The Provox FreeHands FlexiVoice appears to be a useful ASV, which allows for hands-free speech in a larger proportion of laryngectomized patients in the present cohort. The additional manual closure option of the device is beneficial for maintaining the adhesive seal longer.
Original languageEnglish
Pages (from-to)1005-1013
JournalEuropean Archives of Oto-Rhino-Laryngology
Volume274
Issue number2
Early online date14 Sept 2016
DOIs
Publication statusPublished - Feb 2017

Funding

The Netherlands Cancer Institute received a research grant from Atos Medical, Hörby, Sweden, which contributed to the existing infrastructure for health-related quality of life research of the Department of Head and Neck Oncology and Surgery. The University Medical Center Groningen also received a research grant from Atos Medical, Hörby, Sweden. The manufacturer provided the FlexiVoice devices to the patients at no charge.

FundersFunder number
Netherlands Cancer Institute

    Fingerprint

    Dive into the research topics of 'A prospective multicenter clinical feasibility study of a new automatic speaking valve for postlaryngectomy voice rehabilitation'. Together they form a unique fingerprint.

    Cite this