| Part one:Development of Tinnitus Assessment and Sound Therapy SystemObjective:It was the key in our study to give patients individual and effective sound therapies according to the characteristics of tinnitus.In order to reduce the cost of the treatment and treat patients with sound therapy effectively,we developed a set of tinnitus assessment and sound therapy system.Contents:The system included the tinnitus assessment,hearing assessment,sound therapy system and the sound therapy client APP.The tinnitus assessment included tinnitus history questionnaire,Tinnitus Handicap Inventory(THI),Chinese version of Zung Self-Rating Anxiety Scale(SAS),Self-rating Depression Scale(SDS)and Visual Analogue Scale(VAS).The hearing assessment included the pure tone audiometry and tinnitus matching,which was comprised of the tinnitus pitch and loudness matching.The sound therapy system included the selection of sound types,the setting of the loudness,amplitude modulation(AM),the time domain and frequency domain analysis and the preservation functions.Sound types included sine wave(125Hz-8000Hz,octave and 1/3 octave pure tone frequencies),broadband noise and natural sound.The loudness of all kinds of sounds(OdB-110dB)and broadband noise bandwidth(16Hz-10000Hz)could be set.Natural sounds such as the sound of rain,wind,water could be chosen.Conclusion:The system could provide personalized sound therapies for patients with different tinnitus characteristics,and saved the audio files of the sound therapy in mobile devices such as mobile phones by the sound therapy client APP.The devices were convenient for patients to carry and could improve patients' compliance.Part two:Analysis of Acoustic,Psychological,Audiological Characteristics and Related Factors of TinnitusObjective:This part aimed at taking tinnitus assessment in all patients,including tinnitus history questionnaire,THI,SAS,SDS and VAS,analyzing the acoustic,psychological and audiological characteristics of tinnitus and their correlations with the severity of tinnitus and further summarizing them into the representative group of tinnitus characteristics,which could provide a reference for the rational option of sound therapy methods.Methods:From February 2017 to February 2019,154 patients with subjective tinnitus were enrolled in the outpatient department of Otolaryngology,Peking Union Medical College Hospital.They were assessed with the tinnitus history questionnaire,THI,SAS,SDS and VAS evaluation,pure tone audiometry,acoustic immittance,the tinnitus pitch and loudness matching.Using SPSS 17.0 software and Spearman correlation analysis,the correlation between the 18 related factors of tinnitus and the severity of tinnitus was analyzed.Results:A total of 154 patients(79 males and 75 females)were enrolled.The duration of tinnitus ranged from 6 months to 32 years.Most of the patients were between 50 and 60 years old,and most of them were unilateral and persistent cicada tinnitus.25%of the patients had hearing loss,and about 30%of the patients had dizziness,ear tightness,nausea,vomiting and other symptoms.72%of the patients were treated with drug therapy which were ineffective.97%of the patients did not wear hearing aids.37%of the patients had cervical spondylosis,followed by hypertension.The patients with mild(grade-2)handicap accounted for 39%.88%of the patients had no anxiety,and 91%of the patients had no depression.Patients with normal hearing accounted for 61%.According to the results of tinnitus pitch,most of the patients were tinnitus with high frequency,that is,tinnitus frequency>3000Hz.Among the related factors of tinnitus,only the factors that,whether the tinnitus was aggravated in noise environment,whether hearing loss occurred since the tinnitus onset,SAS scores and SDS scores,were related to the severity of tinnitus.Conclusion:Noise environment,hearing impairment,anxiety and depression were highly correlated with the severity of tinnitus.It was suggested that clinicians and relevant departments should actively educate people to avoid risk factors and reduce the risk or severity of tinnitus.At the same time,different characteristics of tinnitus were summarized to provide reference for otolaryngologists to adopt individual sound therapies.Part three:the clinical trial of the efficacy of different sound therapy methods in chronic tinnitus patientsObjective:This part aimed at comparing the efficacy of broadband noise and multiple mixed pure tone frequencies sound therapies in chronic subjective tinnitus with normal and mild hearing loss.This part also aimed at comparing the efficacy of two different mixed pure pure tone frequencies sound therapies in chronic subjective tinnitus.The efficacy of different degrees of hearing loss patients on two different sound therapies were analyzed preliminarily and the possible mechanisms were discussed.Methods:This clinical trial was conducted in the outpatient department of Otolaryngology,Peking Union Medical College Hospital from June 2017 to September 2018.Patients were received sound therapies when they were diagnosed as the subjective tinnitus.A total of 100 patients were enrolled in the clinical trial comparing broadband noise and multiple mixed pure tone frequencies sound therapy methods;56 patients were enrolled in the clinical trial comparing two different mixed pure tone frequencies sound therapy methods.All patients were randomly divided into two groups:A and B,the patients were treated with different sound therapies by using a computer allocation sequence.The pure tone audiometry,tympanometry and tinnitus matching were perfomed.The patients were followed up for 2 weeks,1 month,2 months and 3 months.The Tinnitus Handicap Inventory(THI)and Visual Analog Scales(VAS)measuring were used to evaluate the handicap,loudness and anxiety of tinnitus.An analysis of variance(ANOVA)of 2×5 repeated-measures was conducted by using SPSS 17.0.Results:In the clinical trial of comparing the broadband noise and multiple mixed pure tone frequencies sound therapy,THI scores were significantly lower in Group B than that in Group A after 3 months(p=0.017).There was no significant effect in THI scores in Group A at different follow-up time point(p>0.05).After 1 month(p=0.02),2 months(p=0.00)and 3 months(p=0.00),The THI scores were significantly lower in Group B than those at baseline.Although VAS loudness scores of the two groups decreased at different follow-up time point,there were significant differences between the two groups.VAS loudness and annoyance scores(p<0.05)after 2 and 3 months in Group A were significantly lower than those at baseline.VAS loudness and annoyance scores(p<0.05)after 1,2 and 3 months in Group B were significantly lower than those at baseline.The VAS loudness scores were significantly lower in Group B than in Group A after 2 and 3 months(p<0.05).The VAS annoyance scores were significantly lower in group B than those in group A after 3 months(p<0.05).In the clinical trial of comparing two different mixed pure tone frequencies sound therapy methods,both groups showed significantly lower scores after 3 months than those at baseline which were measured by THI scores(p=0.048,0.016),VAS loudness and annoyance scores(p<0.05).While there was no effect between the two groups.According to the degree of hearing loss,Group A and B were further divided into normal to mild hearing loss group(26-40 dB HL)(Group A1,Group B1),moderate to profound hearing loss group(>41 dB HL group)(Group A2,Group B2).In the patients with normal hearing and mild hearing loss,THI scores(p=0.013),VAS loudness and annoyance scores(p<0.01)after 3 months in Group B1 were significantly lower than those at baseline and the sound therapy of Group B1 was effective.In patients with moderate to profound hearing loss,the THI,VAS loudness and annoyance scores(p<0.01)after 3 months in Group A2 were significantly lower than those at baseline and the sound therapy of Group A2 was effective.Conclusion:Although the multiple mixed pure tone frequencies sound therapies used in our study were effective for only some patients,it may be more effective than the traditional broadband noise sound therapy.Sound therapies for patients with different degrees of hearing loss were different.Most patients' tinnitus could not completely disappear,but it could reduce the severity of tinnitus.Clinicians should use appropriate and individualized sound therapies with corresponding parameters for different characteristics of tinnitus. |
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