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. 2019 Apr;276(4):1039-1047.
doi: 10.1007/s00405-018-05270-y. Epub 2019 Jan 3.

A prospective, non-randomized evaluation of a novel low energy radiofrequency treatment for nasal obstruction and snoring

Detlef Brehmer  1   2   3 , Robert Bodlaj  4 , Friedemann Gerhards  5
Affiliations

A prospective, non-randomized evaluation of a novel low energy radiofrequency treatment for nasal obstruction and snoring

Detlef Brehmer et al. Eur Arch Otorhinolaryngol. 2019 Apr.

Abstract

Background: Weak or inward-bent cartilage of the nasal sidewall at the level of the internal nasal valve (INV) can produce narrowness or collapse of the nasal valve. This is a common cause of impaired nasal breathing during daily activities and there is also an established connection between nasal obstruction and snoring. The condition is often difficult to treat, although even a small enlargement of the lumen at the nasal valve can lead to a significant improvement in the ease of nasal breathing.

Methods: The primary objective of this prospective study was to evaluate the safety and efficacy of the Vivaer system for the treatment of narrowed nasal valves and to measure changes in the symptoms of nasal obstruction and snoring. The Vivaer system uses low energy radiofrequency to remodel the nasal sidewall in order to improve airflow.

Results: The study involved 31 patients presenting from 1st September 2017 to 1st May 2018 with symptoms of nasal obstruction and snoring. In all patients, an improvement was observed in nasal breathing measured by NOSE score, sleep quality by SOS questionnaire and quality of life as measured by EQ-5D and SNOT-22.

Conclusion: Vivaer intranasal remodeling can provide a durable and well-tolerated non-invasive treatment for those patients who are suffering congestion due to narrowness or collapse of the INV.

Keywords: Nasal valve; Nose score; Radiofrequency therapy; Snoring.

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Conflict of interest statement

Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval

The study was approved by the Ethics Commission at the University of Witten/Herdecke, Germany.

Informed consent

The study was conducted in accordance with the principles of Goof Clinical Practices and Declaration of Helsinki (1964 and its revisions). Patients who provided written informed consent, were enrolled in the study.

Figures

Fig. 1
Fig. 1
Schematic diagram summarizing the study design. WatchPAT200: wrist-worn device measuring peripheral arterial tone. NOSE nasal obstruction symptom evaluation scale, LOCF last observation carried forward
Fig. 2
Fig. 2
The RF remodeling platform
Fig. 3
Fig. 3
Handpiece treatment device
Fig. 4
Fig. 4
Treatment points
Fig. 5
Fig. 5
Development of nasal obstruction and snoring: mean (± SEM) of the NOSE and SOS score at pre- and post-treatment assessment time points. NOSE Nasal Obstruction Symptom Evaluation Scale, SOS Snore Outcomes Survey (selected items), RF radiofrequency
See this image and copyright information in PMC

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