Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

Asymmetric Sensorineural Hearing Loss Clinical Trial

Official title:

Effect of an Equalizer-modulated Auditory Intervention on the Asymmetry of Interaural Auditory Perception in Groups of Different Emotional States

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05441891
• Other study ID #: CREC/UH/2022/05
• Status: Completed
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: October 21, 2022

Study information

• Verified date: November 2022
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression.

Description:

The present study follows a randomized, double-blind (investigator and outcome assessor), parallel and controlled design. The auditory intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group are cited to the Health centre, but they do not received any intervention. These subjects follow the same evaluation and data collection process.

Once randomized, all participants will make a first control visit in which a pure-tone audiometry was carry out and completed the various psychiatric evaluation tests to classify into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age, gender, nationality, education, working status, noise exposure, use of ear protection, and present or past use of any analgesic, anxiolytic or antidepressant for longer than a week).

The study variables collected at 3 months were pure-tone audiometry (air conduction).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: October 21, 2022
• Est. primary completion date: October 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 31 Years to 65 Years

Eligibility

Inclusion Criteria:

• Recruited from Health Centre Mejorada del Campo (Madrid, Spain)

Exclusion Criteria:

• Having significant hearing loss

• Having acute otological process

• Having psychotic disease

• Having epilepsy

• Having serious illness

• Having pregnancy

• Used to try alcohol or drugs

Related Conditions & MeSH terms

• Asymmetric Sensorineural Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Other:
• Auditory intervention filter-modulated group
Intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). The musical intervention was always performed with the same songs and in the same order using original CDs, heard through headphones (Beyerdynamic, DT 250 / 80 ohm. GMBH & Co. KG, Theresienstr. 8 D-74072 Heilbronn, Germany). The music was played with a sound system (Panasonic MASH, No. SA-PM24. Hamburg, Germany). and filtered through an equalizer called Earducator (Hollagen Designs, PÍO. Box 43 7864 Bergvliet W.Cape - South Africa) that modulates music by alternating low and high tones with an unpredictable cadence, preventing habituation. It also allows very narrow band complementary filters to attenuate (by about 40 dB) abnormally perceived frequencies (hyper-hearing peaks): filters in: 1 kHz - 1,5 kHz - 2kHz - 3 kHz - 4 kHz - 8kHz.

Locations

Country	Name	City	State
Spain	University of Alcalá	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Brancucci A, Babiloni C, Rossini PM, Romani GL. Right hemisphere specialization for intensity discrimination of musical and speech sounds. Neuropsychologia. 2005;43(13):1916-23. Epub 2005 Mar 21. — View Citation

Frässle S, Paulus FM, Krach S, Schweinberger SR, Stephan KE, Jansen A. Mechanisms of hemispheric lateralization: Asymmetric interhemispheric recruitment in the face perception network. Neuroimage. 2016 Jan 1;124(Pt A):977-988. doi: 10.1016/j.neuroimage.2015.09.055. Epub 2015 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 125 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 250 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 500 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 750 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 1000 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 1500 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 2000 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 3000 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 4000 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 6000 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months	Minimum number of decibels needed to hear a sound at a frequency of 8000 Hz measured in an air conduction pure tone audiometry	Change from Baseline hearing threshold at 3 months
Primary	Anxiety and depression level on the Goldberg scale	To discriminate between these two entities. The following cut-off points were used: a total Anxiety score > 4 detects 73% of all cases of anxiety; a total Depression score >3 detects 82% of all cases of depression	One month
Primary	Anxiety level on the Hamilton scale	It is a clinician-administered scale on which each item is rated from 0 to 4. It yields a score in the range of 0 to 56. The following cut-off points were used: 0-5 points (No anxiety), >5 points (Anxiety).	One month
Primary	Depression level on the Hamilton scale	Each item is rated on a three- or five-point scale, with a score from 0 to 2 or 0 to 4, respectively. It yields a total score in the range of 0 to 52. The following cut-off points were used to assess depression: No depression: 0-7; Depression: >7	One month
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure
Secondary	Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz	Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.	Three months between the first and second measure