Neuromonics Tinnitus Treatment: Third Clinical Trial

Ear & Hearing: April 2007 - Volume 28 - Issue 2 - pp 242-259

doi: 10.1097/AUD.0b013e3180312619

Davis, Paul B.; Paki, Bardia; Hanley, Peter J.

Objectives: The Neuromonics Tinnitus Treatment combines the use of a novel approach to acoustic stimulation with a structured program of counseling and support by a clinician specifically trained in tinnitus rehabilitation. The distinctive acoustic component has been designed to provide stimulation to auditory pathways deprived by hearing loss, engage positively with the limbic system, and allow intermittent, momentary tinnitus perception within a pleasant and relaxing stimulus, thereby facilitating desensitization to the tinnitus signal. The purposes of this study were (1) to demonstrate the efficacy of the treatment, when enhanced with various modifications since previously reported trials and (2) to test the relative clinical effectiveness of two variations of the approach. In the first, intermittent tinnitus perception was facilitated throughout treatment through the use of a stimulus in which intensity peaks allowed the patients' tinnitus perception to be completely covered up, whereas in the intensity troughs their tinnitus was briefly discernible. In the second, subjects experienced little tinnitus perception while listening to the treatment for the first 2 mo, then experienced intermittent perception.

Design: Thirty-five subjects with a predominantly moderate to severe level of tinnitus-related distress before treatment were randomly allocated into one of two treatment groups, corresponding to the two stage-based variations of the Neuromonics Tinnitus Treatment. Participants were provided with a high-fidelity personal sound player with earphones and an acoustic stimulus that had been spectrally modified according to their individual audiometric profile. They were instructed to use the acoustic stimulus for at least 2 hr per day, particularly at those times when their tinnitus was usually disturbing. Each group had equal amounts of clinician time for education, monitoring, and support.

Results: At 2, 4, 6, and 12 mo after commencing treatment, both groups displayed clinically and statistically significant improvements in tinnitus distress, awareness, and minimum masking levels as well as loudness discomfort levels. Improvements increased with time over the first 6 mo of therapy, at which time 91% of all subjects across the two groups reported an improvement in tinnitus disturbance (as measured by the Tinnitus Reaction Questionnaire) of at least 40%, with a mean improvement of 65%. Also, 80% of subjects at 6 mo reported a level of tinnitus disturbance that was no longer clinically significant. There was some indication of a more consistent benefit over 12 mo for the group that was provided initially with a high level of tinnitus interaction; however, inter-group differences were not statistically significant. A relation between reported treatment usage (hours per day) and clinical outcomes was observed, suggesting that a dosage effect may apply with the stimulus provided.

Conclusions: This study found that the Neuromonics Tinnitus Treatment provides rapid and profound improvements to the severity of tinnitus symptoms and their effect on the subject's quality of life. This was a consistent effect, provided by a treatment that subjects reported as being pleasant to use. Both of the stage-based variations of the treatment that were tested in this study were shown to be successful in achieving these outcomes

Chronic cough and irritable larynx

Journal of Allergy and Clinical Immunology (JACI) (Dec 2010) 

Bucca CB, Bugiani M, Culla B, Guida G, Heffler E, Mietta S, Moretto A, Rolla G, Brussino L

BACKGROUND: Perennial rhinitis (PR), chronic rhinosinusitis (CRS), or both, asthma, and gastroesophageal reflux disease (GERD) are the most frequent triggers of chronic cough (CC). Extrathoracic airway receptors might be involved in all 3 conditions because asthma is often associated with PR/CRS and gastroesophageal refluxate might reach the upper airway. We previously found that most patients with rhinosinusitis, postnasal drip, and pharyngolaryngitis show laryngeal hyperresponsiveness (LHR; ie, vocal cord adduction on histamine challenge) that is consistent with an irritable larynx. 

OBJECTIVE: We sought to evaluate the role of LHR in patients with CC. 

METHODS: LHR and bronchial hyperresponsiveness (BHR) to histamine were assessed in 372 patients with CC and in 52 asthmatic control subjects without cough (asthma/CC-). In 172 patients the challenge was repeated after treatment for the underlying cause of cough. RESULTS: The primary trigger of CC was PR/CRS in 208 (56%) patients, asthma in 41 (11%) patients (asthma/CC+), GERD in 62 (17%) patients, and unexplained chronic cough (UNEX) in 61 (16%) patients. LHR prevalence was 76% in patients with PR/CRS, 77% in patients with GERD, 66% in patients with UNEX, 93% in asthma/CC+ patients, and 11% in asthma/CC- patients. Upper airway disease was found in most (95%) asthma/CC+ patients and in 6% of asthma/CC- patients. BHR discriminated asthmatic patients and atopy discriminated patients with PR/CRS from patients with GERD and UNEX. Absence of LHR discriminated asthmatic patients without cough. After treatment, LHR resolved in 63% of the patients and improved in 11%, and BHR resolved in 57% and improved in 18%. 

CONCLUSIONS: An irritable larynx is common in patients with CC and indicates upper airway involvement, whether from rhinitis/sinusitis, gastric reflux, or idiopathic sensory neuropathy.

The effects on cardiac functions and arterial blood gases of totally occluding nasal packs and nasal packs with airway

The Laryngoscope

Volume 120, Issue 11, pages 2325–2330, November 2010

1. Ehab Zeyyan MD¹, 
2. Münir Demir Bajin MD^2,*,
3. Kudret Aytemir MD², 
4. Taner Yılmaz MD¹

Article first published online: 22 OCT 2010

DOI: 10.1002/lary.21064

Abstract

Objective:

To evaluate the effects on cardiac functions and blood arterial gases of totally occluding nasal packs and nasal packs with airway.

Study Design:

Prospective, randomized trial.

Methods:

Thirty-nine adults without any comorbidities underwent septoplasty or septorhinoplasty and had nasal packs placed postoperatively; 19 nasal packs with airways and 20 totally occluding nasal packs. Twenty-four-hour Holter monitorization was done pre- and postoperatively. Arterial blood gas analysis was performed both before the operation and after application of nasal packs.

Results:

Application of packs with airway did not cause any significant changes in blood gas parameters. Packing with totally occluding nasal packs caused a significant decrease in HCO₃ and pCO₂, and insignificant changes in pO₂, O₂ saturation, and pH. No serious arrhythmias were observed in any patient. In both groups, nasal packing resulted in a significant increase in minimum heart rates, a significant decrease in maximum heart rates, and insignificant changes in the mean heart rates. Heart rate variability obtained from 24-hour Holter electrocardiography was analyzed by power spectral analysis. An increase in the high-frequency (HF) domain, a decrease in the low-frequency (LF) domain, and a decrease in the LF/HF ratio were observed after packing in both groups.

Conclusions:

Nasal pack-induced cardiac complications may occur due to increased vagal stimuli secondary to nasal mucosa compression rather than obstruction-related hypoxia. The use of nasal packs in the elderly patients with cardiopulmonary disease warrants close observation. Nasals packs with airways should be preferred in patients susceptible to hypoxia. Laryngoscope, 2010

The effects of uncinectomy and natural ostial dilatation on maxillary sinus ventilation: a clinical experimental study

European Archives of Oto-Rhino-Laryngology (Nov 2010)

Kutluhan A, Salviz M, Bozdemir K, Kanbak O, Ulu M, Yalçiner G, Bilgen AS 

The purpose of this study was to determine the effect of uncinectomy without sinusotomy and natural ostial dilatation on maxillary sinus ventilation in chronic rhinosinusitis. 

Twenty patients with chronic rhinosinusitis were included in this study. The patients were randomly divided into two groups. Group 1 consisted of patients with uncinectomy (n = 10), while group 2 was made up of patients treated with natural ostial dilatation (n = 10). The CO(2) tension and pressure levels of the maxillary sinus during inspiration and expiration phases were obtained and compared before and after the procedures within and between the groups. 

The mean CO(2) tension levels in both groups were significantly decreased after the procedures. The mean maxillary sinus pressure during inspiration was significantly decreased to a negative value after uncinectomy; however, no significant change was observed during expiration. There were no significant changes in maxillary sinus pressures after natural ostial dilatation procedure. Both uncinectomy and natural ostial dilatation seem to be equally effective in decreasing maxillary sinus pCO(2) levels. 

The effects of decreased maxillary sinus pressure during inspiration after uncinectomy on mucociliary clearance and development mechanisms of chronic rhinosinusitis seem to be worth investigating.