| Part 1:Clinical characteristics of patients with chronic subjective tinnitusSection 1:Analysis of the risk factors of decompensated tinnitusObjective:This study was designed to investigate the risk factors of decompensated tinnitus and explore the interaction effect of these risk factors.Methods:We retrospectively analyzed patients with chronic subjective tinnitus who presented to 5 different hospitals in China from September 2019 to November 2020.Demographic characteristics were recorded,and pure tone audiometry and tinnitus-related tests were conducted.Tinnitus severity,sleep,and mental health were assessed by administering the tinnitus handicap inventory(THI),Pittsburgh sleep quality index(PSQI),hospital anxiety and depression scale(HADS),and visual analogue scale(VAS)of tinnitus loudness and annoyance.Results:A total of 338 patients were included(53.3%male,46.7%females).Ninety-nine(29.3%)patients were in the decompensated group.Compared with the compensated tinnitus group,participants with decompensated tinnitus were older and more likely to have comorbidities and disturbed sleep due to tinnitus(p<0.05).They had higher hearing thresholds,tinnitus loudness and minimum masking levels,and scored higher in THI,PSQI,HADS,VASloudness and VAS annoyance(p<0.05).Poor sleep and anxiety were possible risk factors of decompensated tinnitus by a binary logistic analysis.Sleep disturbances and anxiety had an additive interaction that accounted for 87%of the decompensated tinnitus cases in our study(RERI=10.96,S=18.22,AP=0.87).Conclusion:Anxiety and sleep disturbances were possible risk factors of decompensated tinnitus.The combination of poor sleep and anxiety exerted a greater impact on tinnitus severity than either of them individually.Section 2:Key factors of tinnitus severity:a complex network analysisObjective:To explore the key factors related to the severity of chronic subjective tinnitus and investigate the relationship between these factors.Methods:The same group of patients in the Section 1 were enrolled in this study.Demographic information,audiometric and tinnitus-related tests,scores of THI,HADS,PSQI,VAS loudness and VAS annoyance were set as nodes to construct a complex network by R statistical language.Results:The results showed that anxiety and sleep disorder were closely related to THI score,and anxiety was more important.There was a strong correlation between self-reported anxiety and self-reported sleep problem.Demographic characteristics,audiologic and tinnitus-associated tests were not significantly related to THI score.Conclusion:Anxiety and sleep disturbances were possible key factors related to tinnitus severity,and anxiety played a more important role,in line with the results of the first section.There was a certain correlation between sleep disorders and anxiety,and they might have a superimposed effect on tinnitus severity.Future therapies of tinnitus should pay more attention to releasing anxiety and insomnia.Part 2:Comparison of the efficacy of mixed pure tones with broadband noise,broadband noise and placebo on chronic subjective tinnitus:a multicenter,single-blind,randomized controlled trialObjective:To analyze the efficacy of mixed pure tones with broadband noise(MPT+BBN),broadband noise(BBN)and placebo on chronic subjective tinnitus.Methods:This study was a multicenter,three-arm,single-blind,randomized controlled trial,which was conducted in 5 clinical research centers.Eligible study participants were randomized to MPT+BBN,BBN and placebo group for a 3-month treatment.Participants were instructed to undertake audiologic examinations,tinnitus-related tests and fill the psychological questionnaires(THI?HADS?VAS loudness and VAS annoyance)before and after treatment.The THI score was used as the primary evaluation criterion.Patients were blinded in this study.Results:A total of 105 patients were enrolled and 4 withdrew from the trial.The tinnitus loudness in MPT+BBN group decreased more significantly after treatments than those in BBN group and placebo group(p<0.05).The average scores of THI total and subscales in MPT+BBN group decreased after treatment(p<0.001),but there were no obvious changes in the other two groups.After treatments,the changes of THI scores decline much greater than the other groups(p<0.05).The scores of sleep latency,sleep disturbance and daytime function in MPT+BBN group declined after treatment(p<0.05).Conclusion:Sound therapy played more positive roll than placebo in tinnitus.The efficacy of customized acoustic therapy was superior to non-customized sound therapy in the treatment of chronic subjective tinnitus.Part 3.Affecting factors of mixed pure tones with broadband noise on chronic subjective tinnitus:a preliminary studyObjective:To analyze the affecting factors of mixed pure tones with broadband noise(MPT+BBN)on chronic subjective tinnitus.Methods:We retrospectively analyzed patients with subjective chronic tinnitus who undertook MPT+BBN treatment for 3 months in Peking Union Medical College Hospital.Demographic information,audiologic and tinnitus-related tests were collected.All the patients filled the psychological questionnaires before and after treatment.The THI total score decreased more than 20 points was considered effective.Results:A total of 65 patients were enrolled.18(27.7%)patients were in the effective group and 47(72.3%)were in the non-effective group.More female patients(44.7%)and low-medium frequency tinnitus(50%)were in the effective group.Patients in effective group scored much higher in THI of pre-treatment than patients in non-effective group.The results of the binary logistic analysis showed that tinnitus pitch(OR=6.45,95%CI:1.34?3 1.18,p=0.020)and THI score of pre-treatment(OR=25.65,95%CI:5.25?125.34,p<0.001)were significantly related to therapeutic effectiveness.Conclusion:The tinnitus pitch and the severity of tinnitus before treatment were the main factors affecting the curative effects of MPT+BBN on chronic subjective tinnitus.Patients with low-medium frequency and decompensated tinnitus may have better curative effects after 3-month MPT+BBN than others. |
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