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

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.

Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis.

OBJECTIVE: To assess the long-term safety and effectiveness of temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN), a minimally invasive treatment for chronic rhinitis. METHODS: A prospective, single-arm study of 129 patients at 16 centers (United States, Germany) was conducted. Patient-reported outcome measures were the 24-h reflective total nasal symptom score (rTNSS) and mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ). Postnasal drip and cough symptoms were assessed using a 4-point scale. RESULTS: The mean pretreatment rTNSS was 7.8 (95% CI, 7.5-8.1). The significant rTNSS treatment effect at 3 months (-4.2 [95% CI, -4.6 to -3.8]; p < 0.001) was sustained through 2 years (-4.5 [95% CI, -5.0 to -3.9]; p < 0.001), a 57.7% improvement. At 2 years, the proportion of patients with a minimal clinically important difference (MCID) of ≥30% improvement in rTNSS from baseline was 80.0% (95% CI, 71.4%-86.5%). Individual postnasal drip and cough symptom scores were significantly improved from baseline through 2 years. The proportion of patients who reached the MCID for the MiniRQLQ (≥0.4-point improvement) at 2 years was 77.4% (95% CI, 68.5%-84.3%). Of 81 patients using chronic rhinitis medications at baseline, 61.7% either stopped all medication use (28.4%) or stopped or decreased (33.3%) use of ≥1 medication class at 2 years. No device/procedure-related serious adverse events were reported throughout 2 years. CONCLUSION: TCRF neurolysis of the PNN resulted in sustained improvements in chronic rhinitis symptom burden and quality of life through 2 years, accompanied by a substantial decrease in medication burden. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2077-2084, 2024.

Endonasal phototherapy significantly alleviates symptoms of allergic rhinitis, but has a limited impact on the nasal mucosal immune cells.

The literature documents the fact that UV irradiation of cutaneous Langerhans cells (LC) in vivo prevents the development of contact allergy and produces long-lasting immunosuppression. However, not much is known about the effect of UV irradiation on the LC of the nasal mucosa and their connection with clinical scores. Local antigen presentation may be necessary for both primary and recall T cell responses to birch pollen in patients with hay fever. Endonasal phototherapy combination of UVB (5%), UVA (25%) and visible light (70%) utilises the immunosuppressive effects of UV irradiation. The aim of this study was to correlate clinical symptom scores with possible changes in the LC of the nasal mucosa induced by UV radiation. The clinical effectiveness of this form of treatment is discussed. Nasal biopsies were obtained from ten birch pollen-sensitive patients with seasonal rhinitis before and after endonasal phototherapy. All patients showed a significant clinical benefit post-treatment as assessed by standardised instruments, including total nasal symptom score, nasal congestion score, nasal itching score, sneezing score, nasal secretion score and impairment-to-health score. However, we found no significant morphological changes, to, or quantitative differences in, the CD1a+, CD4, CD8 or CD31 cells before and 14 days after treatment. Despite the positive clinical effect, the study revealed no effect of UV irradiation on the LC and other analysed cells of the nasal mucosa immune system. Possible reasons for this are discussed.

Rhinitis sicca, dry nose and atrophic rhinitis: a review of the literature.

Despite the fact that many people suffer from it, an unequivocal definition of dry nose (DN) is not available. Symptoms range from the purely subjective sensation of a rather dry nose to visible crusting of the (inner) nose (nasal mucosa), and a wide range of combinations are met with. Relevant diseases are termed rhinitis sicca anterior, primary and secondary rhinitis atrophicans, rhinitis atrophicans with foetor (ozena), and empty nose syndrome. The diagnosis is based mainly on the patient's history, inspection of the external and inner nose, endoscopy of the nasal cavity (and paranasal sinuses) and the nasopharynx, with CT, allergy testing and microbiological swabs being performed where indicated. Treatment consists in the elimination of predisposing factors, moistening, removal of crusts, avoidance of injurious factors, care of the mucosa, treatment of infections and where applicable, correction of an over-large air space. Since the uncritical resection of the nasal turbinates is a significant and frequent factor in the genesis of dry nose, secondary RA and ENS, the inferior and middle turbinate should not be resected without adequate justification, and the simultaneous removal of both should not be done other than for a malignant condition. In this paper, we review both the aetiology and clinical presentation of the conditions associated with the symptom dry nose, and its conservative and surgical management.

[Clinical post-approval studies as part of the Therapy Allergen Regulation (TAV): A systematic review]. / Klinische Nachzulassungsstudien im Rahmen der Therapieallergene-Verordnung (TAV): Eine systematische Recherche.

With the introduction of the Therapy Allergens Ordinance (TAV) the previously unapproved therapeutic allergens on the existing market need to be checked for their risk-benefit ratio as a basic prerequisite for approval under pharmaceutical law. This process is criticized because it can lead to long transition periods so that patients will probably be treated for two decades with preparations whose effectiveness has not yet been proven and may never be proven. The aim of this work is to list the critical preparations for which no publicly accessible study activity has been recorded since the beginning of the TAV in 2008. For this purpose, the European Clinical Trials Register (clinicaltrialsregister.eu) and the American study register (ClinicalTrials.gov) are systematically searched. The following hypothesis, consistent with the TAV, will be checked: "In the past years, study programs were carried out for the preparations in the process of the TAV - the majority of these preparations are about to be approved by PEI". The hypothesis is refuted with the findings of this work. In fact, no preparation can currently be identified that is about to be TAV approved. 61 preparations are currently in the TAV process; only two preparations have already passed this successfully. If the total of 63 (61+2) preparations are combined in the homologous groups - trees, grasses, mites and mixtures -, there are 33 preparations that can be classified as follows: For the 33 preparations in the TAV process, 36 studies (phase II and III) that may potentially be relevant for TAV were found as part of the screening. For 15 of these studies the results have duly been entered in the European study register. The results of another 13 studies have not been stored in the study register although they are marked as completed. No information has been stored in the European study register for four studies so that the status of these studies remains unclear. Four studies have not yet been completed. Responsible doctors can make recommendations for the prescription of a certain SIT preparation only if there is adequate evidence of its effectiveness. For preparations that have not yet started studies more than ten years after the introduction of the TAV, it is very doubtful whether approval can still be obtained or whether it is even being sought. For the three main inhaled allergens (grasses, trees and mites) there is already a selection of approved, evidence-based and effective alternatives for both subcutaneous (SCIT) and sublingual (SLIT) application from various manufacturers on the market. The use of therapies that have been approved and proven effective is essential in terms of guideline-compliant, sensible care for patients.

The relationship between pre-fitting expectations and willingness to use hearing aids.

Hearing-aid use in the elderly population is problematic since not all people who would benefit from hearing aids actually obtain one. In this study, the relationship between pre-fitting expectations and willingness to use hearing aids is addressed. One hundred adult hearing aid candidates (mean age 68.6 years) were randomly recruited from eight different private ENT practices. The subjects completed a questionnaire comprising a number of different aspects of expectation and some additional variables potentially influencing willingness to use hearing aids. Based on the outcome of the questionnaire a linear regression model predicting motivation to use hearing aids was calculated and evaluated. Among the 11 parameters evaluated three contributed significantly to the model of willingness. The three predictor variables were expectations towards improvement of quality of life, stigmatization, and self-rated hearing ability. They accounted for about 55% of the variability in the data for willingness. Examination of a sub-sample three months after the survey had taken place revealed a distinct relationship between willingness and the decision to obtain or decline hearing aids. In conclusion, the results strongly encourage supporting positive expectations in order to motivate individuals with hearing impairment to use hearing systems.

Self-treatment of benign paroxysmal positional vertigo with DizzyFix, a new dynamic visual device.

Benign paroxysmal positional vertigo is one of the most common disorders of the vestibular system. It is characterized by episodes of recurrent vertigo triggered by head movements or position changes associated with nystagmus. There is scientific evidence that in the majority of cases this condition responds well to the particle repositioning maneuver (PRM) correctly performed by the physician. However, the PRM needs to be repeated in approximately 30% of the cases. Although the maneuver is simple, patients often find it difficult to perform correctly as self-treatment, with the result that it fails to bring about an improvement in the symptoms. DizzyFix (Clearwater Clinical Limited, Canada) is the name given to a new dynamic visual device designed to provide a visual representation of the PRM based on the canalith theory. The DizzyFiX consists of a specially curved acrylic tube containing a nontoxic viscous fluid and a bead, the purpose of which is to help the patient and the inexperienced physician to perform the PRM correctly. A randomized clinical trial has shown that it reliably enables the maneuver to be performed correctly, and a study investigating the effectiveness of patient self-treatment of benign paroxysmal positional vertigo with the device in comparison with standard office treatment revealed both techniques to be equally effective. The device has now been approved by the US FDA.

Endonasal phototherapy with Rhinolight for the treatment of allergic rhinitis.

Allergic rhinitis, although not life threatening, significantly affects the quality of the patient's daily life. The three major steps in the treatment of the condition are avoidance of allergens, treatment of symptoms (in particular, antihistaminics and topical nasal corticosteroids) and specific immunotherapy. Avoidance of the allergen is usually not possible and symptom relief is often limited, despite the availability of a number of pharmacological options. Specific immunotherapy demands a high level of cooperation on the part of the patient for at least 3 years. Endonasal phototherapy with the Rhinolight device (Rhinolight Ltd, Szeged, Hungary) for the treatment of immunoglobulin E-mediated allergic rhinitis is a new option that utilizes the immunosuppressive effects of UV radiation. The method directs a combination of UV-B (5%), UV-A (25%) and visible light (70%) into the nasal cavity, and its effectiveness has been demonstrated in one double-blind, placebo-controlled study. The results of additional studies have been presented at various medical conferences and in abstracts. Reports in the literature confirm that phototherapy is a well-established and successful treatment of atopic dermatitis and other skin diseases.

The rhinolith-a possible differential diagnosis of a unilateral nasal obstruction.

Rhinoliths are mineralised foreign bodies in the nasal cavity that are a chance finding at anterior rhinoscopy. Undiscovered, they grow appreciably in size and can cause a foul-smelling nasal discharge and breathing problems. Giant nasal stones are now a very rare occurrence, since improved diagnostic techniques, such as endoscopic/microscopic rhinoscopy, now make it possible to identify foreign bodies at an early stage of development. We report the case of a 37-year-old patient who, at the age of 5-6 years, introduced a foreign body, probably a stone, into his right nasal cavity. On presentation, he complained of difficulty in breathing through the right nostril that had persisted for the last 10 years. For the past four years a strong fetid smell from the nose had been apparent to those in his vicinity. Under general anaesthesia, the stone was removed in toto from the right nasal cavity. The possible genesis of the rhinolith is discussed, our case compared with those described in the literature, and possible differential diagnoses are considered.