Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

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

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.

Study Overview

• Status: Completed
• Conditions: Asymmetric Sensorineural Hearing Loss
• Intervention / Treatment: Other: Auditory intervention filter-modulated group

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • University of Alcala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants assigned to the control group are cited to the Health centre, but they do not suffer any intervention. These subjects followed the same evaluation and data collection process.
Active Comparator: Auditory intervention filter-modulated; Participants assigned to this group listened 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).	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.; Other Names: Bérard´s method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Principal Investigator: Beatriz Estalayo-Gutierrez, MD, PhD, University of Alcala

Publications and helpful links

General Publications

• Frassle 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.
• 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. doi: 10.1016/j.neuropsychologia.2005.03.005. Epub 2005 Mar 21.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Actual): October 19, 2022
• Study Completion (Actual): October 21, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hearing asymmetry; mental disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: CREC/UH/2022/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No