Impact of the COVID-19 Lockdown on Patients with Chronic Tinnitus—Preliminary Results

Round 1

Reviewer 1 Report

This article is very interesting, clear and well-written. The reference list is updated and complete. I have no suggestions.

Author Response

Dear Reviewer ,

we appreciate the time and effort that you have dedicated to providing your valuable feedback on this manuscript. 

Reviewer 2 Report

I recommend a few modification.

Please check English by a native speaker!

Please describe the abbreviations when you use them for the first time.

The paragraph between row 128 and 140 is extremely hard to read, rewrite please.

Can you campare with study form surrounding regions.

I  think that you need three short conclusions!

My recommendation is to focus on short conclusions!

 

Author Response

Dear Reviewer,

Thank you for giving us the opportunity to respond to your comments and submit a revised draft of our manuscript to Audiology Research. We appreciate the time and effort that you have dedicated to providing your valuable feedback on this manuscript. We look forward to responding to your comments and suggestions point-by-point. Find our responses to each comment highlighted below.

Please check English by a native speaker!

-We did a check English as you suggested.

Please describe the abbreviations when you use them for the first time.

-We add Tinnitus Sample Case History at line 72.

The paragraph between row 128 and 140 is extremely hard to read, rewrite please.

-We rewrited the paragraph as you suggested. 

THI, BDI and BAI total scores were considered as continuous variables and were presented as mean and standard deviation. The mean score of these questionnaires before COVID-19 and after lockdown period was evaluated with the t-test for paired data. The Fischer exact test was used to examine the possible differences between different grades for the THI, BDI and BAI before COVID-19 and after lockdown.

Can you campare with study form surrounding regions.

- Thanks for your comment. We didn't find published data about tinnitus and pandemic from surrounding regions in Italy. We report in the discussion the German study of Schlee et al.

I  think that you need three short conclusions!

 -We report three short conclusions, as you suggested, at the end of the manuscript

Reviewer 3 Report

-The abstract can include information on positive/non-positive COVID-19 subjects included in the study

-Please explain better/more understandable the last sentence in the abstract (row 21-23) related to the general statement on the “heterogeneous course of tinnitus.”

-Row 72, give the full term for TSCH since it is the first appearance in the manuscript text (excluding the abstract)

 

-Row 86, could authors present a table or give in more detail the number of subjects regarding specific therapies the subjects were taking (dividing cognitive therapy, pharmacotherapy (which one  etc.)..)

 

-Row 90, the first sentence should be extended to contain a list of standardized tests used.

The subheadings like 2.2.1 to 22.5 should be erased since each test can be easily presented as one subheading.

-Row 131, “…severity and handicap evaluated with TSCH and THI, we assessed depression..” should be rewritten without using  “we” but rather “ the depression and anxiety were assessed..”

-Row 204, “The use of THI allowed us to evaluate how the impact of tinnitus on quality of life..” shouldbe rewritten like without using the term “us”

-Row 212, the term “in our study”, rather to use term “in the present study”

-Row 225, the term “we do not know” and the sentence need to be reformulated

-Row 266, the sentence should be written more understandable “From a noise exposure point of view, the COVID-19 pandemic had only the benefits of reducing it [36]”.

 

 

 

Author Response

Dear Reviewer,

Thank you for giving us the opportunity to respond to your comments and submit a revised draft of our manuscript to Audiology Research. We appreciate the time and effort that you have dedicated to providing your valuable feedback on this manuscript. We look forward to responding to your comments and suggestions point-by-point. Find our responses to each comment highlighted below.

-The abstract can include information on positive/non-positive COVID-19 subjects included in the study

We added this sentence in the abstract "Only 2 patients (0.5%) were infected by COVID-19 (positive to RT-PCR) and they didn’t report any worsening of tinnitus"

-Please explain better/more understandable the last sentence in the abstract (row 21-23) related to the general statement on the “heterogeneous course of tinnitus.”

We explain better the sentence: According to the data of the literature, our patients experienced an heterogeneous course of the tinnitus and the severity of tinnitus was not significantly affected by lifestyle changes during the COVID-19 pandemic and lockdown.

-Row 72, give the full term for TSCH since it is the first appearance in the manuscript text (excluding the abstract)

Ok, we did it.

-Row 86, could authors present a table or give in more detail the number of subjects regarding specific therapies the subjects were taking (dividing cognitive therapy, pharmacotherapy (which one  etc.)..)

Thanks for this comment. Unfortunately this is not the aim of the study and we didn't analyze the specific therapies. In addiction, patients sometimes start the therapy with a pharmacotherapy and after the first follow up start CBT and/or sound therapy. So it's difficult to collect homogeneous groups of patients regarding therapies.

-Row 90, the first sentence should be extended to contain a list of standardized tests used.

The sentence was extendend as requested: "All patients filled out standardized questionnaires: TSCH, Tinnitus Handicap Inventory (THI), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI)."

The subheadings like 2.2.1 to 22.5 should be erased since each test can be easily presented as one subheading.

We added the subheading 2.2.1 Standardized questionnaires

-Row 131, “…severity and handicap evaluated with TSCH and THI, we assessed depression..” should be rewritten without using  “we” but rather “ the depression and anxiety were assessed..”

Thanks, we did the correction requested at row 195 "depression and anxiety were assessed with BDI and BAI"

-Row 204, “The use of THI allowed us to evaluate how the impact of tinnitus on quality of life..” shouldbe rewritten like without using the term “us”

Thanks, we did the correction requested.

-Row 212, the term “in our study”, rather to use term “in the present study”

Thanks, we did the correction requested.

-Row 225, the term “we do not know” and the sentence need to be reformulated

Thanks, the sentence was reformulated: "Based on the present data it’s not clear if the low mood was due to the tinnitus or to the lifestyle changes after lockdown"

-Row 266, the sentence should be written more understandable “From a noise exposure point of view, the COVID-19 pandemic had only the benefits of reducing it [36]”.

Thanks, the sentence was reformulated: COVID-19 pandemic had the benefits of reducing the noise exposure during the lockdown

Reviewer 4 Report

Dear Ladies and Gentlemen, Dear Journal-Team,

the interesting manuscript 'Impact of the COVID-19 lockdown in patients with chronic tinnitus - preliminary results' describes the effect of a one year pandemic situation with intermittent economic and social lockdown measures on the tinnitus perception and related depression and anxiety in Italy. It is well written. The table and the figure are sufficient. 

1. Minor points: Please change to 'was effectuated' (line 127), insert a full-stop before 'Based' (line 259), correct the punctuation before 'The absence' (line 289).

2. Please check the References according to the Journal Style Guidelines and for accuracy, e.g. for punctuation (Reference 20, after the first author), for the number of listed authors (Reference 17, 22, 29, 30, 31), full-stop use at the end (reference 28, 37, 38, 40, 42, 48, 50, 52), line spacing (Reference 32, and between 37-40), uniform style for digital identification (Reference 17, 20, 30), author names (Reference 44).

Sincerely,

Author Response

Dear Reviewer,

Thank you for giving us the opportunity to respond to your comments and submit a revised draft of our manuscript to Audiology Research. We appreciate the time and effort that you have dedicated to providing your valuable feedback on this manuscript. Find our corrections to each comment in the latest version of the manuscript.

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.

Round 1

Reviewer 1 Report

The authors demonstrated the changes of tinnitus-related symptoms before and after COVID-19 lockdown measures It is very interesting, but there are lots of issues needing verifications. 

 

1. The limited number of enrolled patients could decrease the statistical power. It is better to enroll more subjects to assess the influence of COVID-19 related lockdown.

 

2. The authors have to address how to differentiate the natural course of tinnitus and the tinnitus changes according to lockdown measures? In addition, individual variabilities such as lifestyle change after lockdown or stress resilience were not considered in the analysis.

 

3. The authors reported the results with tables, it is better to demonstrate the results as figures to show the difference of parameters before and after lockdown measures.

 

4. For the last, please check again whether the statistical analysis method is correct.

Author Response

We thank you very much for your critique of our manuscript and your important recommendations.

1.You pointed out the limited number of patients in the study and the consequent decrease of the statistical power. We added this point in the limits of the study. Unfortunately the sample was small because 37 patients did not answer the phone / mail or did not have time to answer the survey as reported in the results.

2. Following your suggestions, we revised the limits of the study.

3. We reported the results in figures as you suggested.

4. The statistical analysis method was checked again.

Author Response File: Author Response.pdf

Reviewer 2 Report

Topics of the work at the time of the pandemic and the presented results are predictable. It would be interesting to know what types of treatment were used in the subjects (e.g. TRT, hearing aids, tinnitus maskers or pharmacotherapy)?

Author Response

Thanks for your comments.

We added in the methods a comment on the therapy.

Author Response File: Author Response.pdf

Reviewer 3 Report

This article explores the perception of the tinnitus related to lifestyle changes during the COVID-19 pandemic and lockdown. The design of the study, procedures and statistics are good. I think that these data are worth of publication, but I have some minor comments:

• “the same data emerged for people with chronic diseases, probably because COVID-19 has increased a greater sense of vulnerability and fear” … “led to major changing in daily life activities, such as physical exercise, sexuality and nutrition” … I suggest to discuss and cite studies on migraine exploring lifestyle (physical activity, nutrition and sleep). Indeed, it has been reported that anxiety, sleep disorders and psychiatric features might appear even in absence of COVID infection during pandemic in migraineurs (see “Social Distancing in Chronic Migraine during the COVID-19 Outbreak: Results from a Multicenter Observational Study. Nutrients. 2021”). In particular, patients with migraine (almost always females) worsening during lockdown presented higher BDI scores and impaired sleep demonstrated by ISI scores during the lockdown. I think that this study supports the findings described here for tinnitus.
• “Only 2 patients (0.5%) were infected by COVID-19 (positive to RT-PCR) and they didn’t report any worsening of tinnitus.” COVID infection did not influence the outcome of tinnitus, thus supporting the effect of lifestyle and psychological distress.
• The results are in line with those of previous research that highlighted greater psychological distress for women during the pandemic. How do the authors explain the higher distress in women? I believe that the pandemic might be a precipitating factor for functional neurological disorders (more frequent in female), including tinnitus.
• Have brainstem evoked potential or blink reflex been recorded in these patients? Any patients treated with TMS?

Author Response

Thank you for the significant recommendations.

• “the same data emerged for people with chronic diseases, probably because COVID-19 has increased a greater sense of vulnerability and fear” … “led to major changing in daily life activities, such as physical exercise, sexuality and nutrition” … I suggest to discuss and cite studies on migraine exploring lifestyle (physical activity, nutrition and sleep). Indeed, it has been reported that anxiety, sleep disorders and psychiatric features might appear even in absence of COVID infection during pandemic in migraineurs (see “Social Distancing in Chronic Migraine during the COVID-19 Outbreak: Results from a Multicenter Observational Study. Nutrients. 2021”). In particular, patients with migraine (almost always females) worsening during lockdown presented higher BDI scores and impaired sleep demonstrated by ISI scores during the lockdown. I think that this study supports the findings described here for tinnitus.

Thanks for your comment, we added it in the discussion.

• “Only 2 patients (0.5%) were infected by COVID-19 (positive to RT-PCR) and they didn’t report any worsening of tinnitus.” COVID infection did not influence the outcome of tinnitus, thus supporting the effect of lifestyle and psychological distress.

We added in the discussion this comment: "Based on the small number of patients infected by COVID-19 in our study we could not state if the COVID infection influence the outcome of tinnitus".

• The results are in line with those of previous research that highlighted greater psychological distress for women during the pandemic. How do the authors explain the higher distress in women? I believe that the pandemic might be a precipitating factor for functional neurological disorders (more frequent in female), including tinnitus.

In the general population, women report higher levels of anxiety and depression. In the conclusions we already say that there is a greater emotional vulnerability in the female population. The pandemic could be a precipitating factor for functional neurological disorders (more frequent in female)? Unfortunately, based on our results we can't confirm this hypothesis. In our study we have no elements to say that women were worse for tinnitus (also because there is no significant change in THI); most likely they were more stressed by many commitments and roles they have to manage (just to name one they had certainly been behind their children more and often have lost their jobs).

 

• Have brainstem evoked potential or blink reflex been recorded in these patients? Any patients treated with TMS?

ABR and blink reflex were not recorded in these patients. The TMS is not available in our Center.

Author Response File: Author Response.pdf

Reviewer 4 Report

I personally believe the authors should have asked for the patients’ noise exposure that they usually have in their life before the pandemic situation and the noise exposure they have during the home confinement. From a noise exposure point of view, the COVID had only the benefits of reducing it (Asensio, C., Aumond, P., Can, A., Gascó, L., Lercher, P., Wunderli, J. M., ... & Licitra, G. (2020). A Taxonomy Proposal for the Assessment of the Changes in Soundscape Resulting from the COVID-19 Lockdown. International journal of environmental research and public health, 17(12), 4205.), both from reducing the noise sources outside cutting down the traffic flows, and for noise exposure in working environments. This one, obviously depends on the working activities, while the previous one depends on a lot of parameters, mainly depending on where the patients live. For the last part, I suggest the authors to be in contact with environmental noise experts to put in the team, in order to significantly improve the variable of the work.

In fact, my idea is that neglecting the change in noise exposure would significantly alter the outcome of the submitted work. It can be a real bias.

 

The authors basically introduced it as “ masking sounds” at line 45 in the introduction, but is more than just that. However, this part can be a good point where to insert some details more on environmental noise exposure and the potential sources producing it. This will help improve at least the connections of the work and the reference sections. The following is a possible suggestion: Exposure to noise is associated to sleep disorders with awakenings (Muzet A. Environmental noise, sleep and health. Sleep Med Rev 2007; 11: 135–42), learning impairment (Zacarías, F. F., Molina, R. H., Ancela, J. L. C., López, S. L., & Ojembarrena, A. A. (2013). Noise exposure in preterm infants treated with respiratory support using neonatal helmets. Acta Acustica united with Acustica, 99(4), 590-597; Erickson, Lucy C., and Rochelle S. Newman. "Influences of background noise on infants and children." Current Directions in Psychological Science 26.5 (2017): 451-457.), hypertension ischemic heart disease (Dratva, J., et al. (2012). “Transportation noise and blood pressure in a population‐based sample of adults.” Environmental Health Perspectives, 120(1): 50–55. Babisch, W., Beule, B., Schust, M., Kersten, N., Ising, H., ‘Traffic noise and risk of myocardial infarction’, Epidemiology, 16, 2005, pp. 33–40. ), diastolic blood pressure (Petri, D., Licitra, G., Vigotti, M. A. & Fredianelli, L. (2021). Effects of Exposure to Road, Railway, Airport and Recreational Noise on Blood Pressure and Hypertension. Int. J. Environ. Res. Public Health 2021, 18(17), 9145), reduction of working performance (Vukić, L., Fredianelli, L., & Plazibat, V. (2021). Seafarers’ Perception and Attitudes towards Noise Emission on Board Ships. International Journal of Environmental Research and Public Health, 18(12), 6671. Rossi, L., Prato, A., Lesina, L., & Schiavi, A. (2018). Effects of low-frequency noise on human cognitive performances in laboratory. Building Acoustics, 25(1), 17-33.), annoyance (Miedema HME, Oudshoorn CGM. Annoyance from transportation noise: relationships with exposure metrics DNL and DENL and their confidence intervals. Environ Health Perspect 2001; 109: 409–16;). Major sources that resulted to be the most impactful on human life style are road traffic (Cueto, J. L., Petrovici, A. M., Hernández, R., & Fernández, F. (2017). Analysis of the Impact of Bus Signal Priority on Urban Noise. Acta Acustica united with Acustica, 103(4), 561-573.Morley, D. W., et al. "International scale implementation of the CNOSSOS-EU road traffic noise prediction model for epidemiological studies." Environmental pollution 206 (2015): 332-341. Ruiz-Padillo, Alejandro, et al. "Selection of suitable alternatives to reduce the environmental impact of road traffic noise using a fuzzy multi-criteria decision model." Environmental Impact Assessment Review 61 (2016): 8-1), railway traffic (Bunn, Fernando, and Paulo Henrique Trombetta Zannin. "Assessment of railway noise in an urban setting." Applied Acoustics 104 (2016): 16-23), airports (Iglesias-Merchan, Carlos, Luis Diaz-Balteiro, and Mario Soliño. "Transportation planning and quiet natural areas preservation: Aircraft overflights noise assessment in a National Park." Transportation Research Part D: Transport and Environment 41 (2015): 1-12), port activities (Nastasi, Marco, et al. "Parameters affecting noise emitted by ships moving in port areas." Sustainability 12.20 (2020): 8742.). are the most diffused ones”.

Moreover, when mentioning environmental noise and COVID relationship, just keep in mind that there are many references in literature. Some certified that people was more sensitive to noise in a quieter environment. Tong, H., Aletta, F., Mitchell, A., Oberman, T., & Kang, J. (2021). Increases in noise complaints during the COVID-19 lockdown in Spring 2020: A case study in Greater London, UK. Science of The Total Environment, 785, 147213; Mishra, A., Das, S., Singh, D., & Maurya, A. K. (2021). Effect of COVID-19 lockdown on noise pollution levels in an Indian city: a case study of Kanpur. Environmental Science and Pollution Research, 28(33), 46007-46019. And other…

 

In the methodology, please report the city where investigated people live.

Conclusions are short and should better summarize the work and the results.

In the limitations I would surely report what I previously said about a total absence of noise exposure evaluation. I understand that this would be difficult to perform now, but it represents a real limitation and a bias to the work. In this way, the results are just “preliminary” . At least, It should be reported in the methodology the type of environment where patients live (urban, country, vicinity of rails, airports, and so on according to the sources suggestions I gave before.). The correct assessment would have take a look at the previous noise maps, which for big city is available ( I can guess the study took place in Rome?). Then, pandemic noise exposure should have been measured (best option) or at least extimated.

 

Author Response

We really appreciate your suggestions about the role of noise exposure and to be in contact with environmental noise experts to put in the team, in order to significantly improve the variable of a future work.

We improved methodology, discussion and limits of the study as you suggested. Neglecting the change in noise exposure would significantly alter the outcome of the submitted work and it's a significant limit of the study.

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

There are many factors that influence the treatment of tinnitus. In this study, the basic baseline characteristics of the control group and the study group were not considered. To overcome this, it is reasonable to include a larger number of patients. It is recommended that a larger number of patients must be involved in the analysis.

Author Response

We really agree with you that there are many factors that influence the treatment of tinnitus but the aim of the current study is to evaluate the psychological effects of lockdown measures in a study group of patients with subjective chronic tinnitus diagnosed before the COVID-19 pandemic. We reported the basic baseline characteristics of the study group before the pandemic and after the lockdown in figure 1. We also reported the kind of treatments of the patients, as requested by another reviewer, but we didn't analyze the effect of the treatments after the pandemic. All the treatments were suggested before the pandemic. As reported in the limits of the study this is a preliminary study based on the small number of patients included (37 of 77 patients did not answer the phone/mail or did not have time to answer the survey). We absolutely agree with your recommendation to involve a major number of patients in the analysis of a future work when the restriction measures will completely end.

Author Response File: Author Response.pdf

Reviewer 4 Report

The authors partially applied the suggestions reported. I believe they can take a bit more time looking at the previous round of revisions, filling the gaps that they have not yet filled.

Moreover, Conclusions should be richer and better summarize the work.

Author Response

• As reported in the conclusion of this preliminary study, unfortunately we didn’t evaluate the role of pandemic noise exposure in the perception of tinnitus so it could be useful to evaluate the noise exposure in a future work with a bigger sample. For this reason we reported all your suggestions in the discussion after lines 265:

A final consideration is about the patients’ noise exposure that they usually have in their life before the pandemic situation and the noise exposure they have during the home confinement.  From a noise exposure point of view, the COVID-19 pandemic had only the benefits of reducing it [36]. Reducing the noise sources outside cutting down the traffic flows depends on a lot of parameters, mainly on where the patients live. The majority of our patients lived in a urban environment. Noise exposure in working environments obviously depends on the working activities. 
Exposure to noise is associated to sleep disorders with awakenings [37], learning impairment [38,39], hypertension, ischemic heart disease [40,41],diastolic blood pressure [42], reduction of working performance [43,44], annoyance [45]. Major sources that resulted to be the most impactful on human life style are road traffic [46,47,48], railway traffic [49], airports [50], port activities [51].
Environmental noise and COVID relationship is well documented in literature, as some subjects were more sensitive to noise in a quieter environment [52,53].

• We added in the limits of the study that it's a preliminary study and that the total absence of noise exposure evaluation also represents a bias to the work. 
• We added in the methodology at line 137 that many patients lived in Rome so in a urban environment.
• We improved the conclusions as requested:

According to the data of the literature, our patients experienced heterogeneity of the individual perception of the tinnitus related to lifestyle changes during the COVID-19 pandemic and lockdown. These results may be affected by other factors, like stress, noise exposure, anxiety and depression. In this study we didn’t evaluate the role of pandemic noise exposure in the perception of tinnitus so it could be useful to evaluate the noise exposure in a future work with a bigger sample. Based on the THI scores, no significant differences were found comparing the results obtained before COVID-19 pandemic and after lockdown, also distinguishing data according to age differences. Male patients have not developed a worsening of their quality of life related to tinnitus during the lockdown. The findings of the current study show that anxiety and depression in tinnitus patients are more prevalent among women.

Author Response File: Author Response.pdf