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Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

Primary Purpose

Asymmetric Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Auditory intervention filter-modulated group
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asymmetric Sensorineural Hearing Loss focused on measuring hearing asymmetry, mental disorders

Eligibility Criteria

31 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alcalá

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Auditory intervention filter-modulated

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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 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 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 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 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 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 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 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 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 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 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
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
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).
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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 22, 2022
Last Updated
November 1, 2022
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT05441891
Brief Title
Effect of Modulated Auditory Stimulation on Interaural Auditory Perception
Official Title
Effect of an Equalizer-modulated Auditory Intervention on the Asymmetry of Interaural Auditory Perception in Groups of Different Emotional States
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymmetric Sensorineural Hearing Loss
Keywords
hearing asymmetry, mental disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel, pre-post study design
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants not received any intervention. The researchers in charge of outcome assessment and statistical analysis are blinded to the allocation of participants
Allocation
Randomized
Enrollment
233 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Auditory intervention filter-modulated
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Auditory intervention filter-modulated group
Other Intervention Name(s)
Bérard´s method
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 125 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 250 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 500 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 750 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 1000 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 1500 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 2000 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 3000 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 4000 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 6000 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months
Description
Minimum number of decibels needed to hear a sound at a frequency of 8000 Hz measured in an air conduction pure tone audiometry
Time Frame
Change from Baseline hearing threshold at 3 months
Title
Anxiety and depression level on the Goldberg scale
Description
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
Time Frame
One month
Title
Anxiety level on the Hamilton scale
Description
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).
Time Frame
One month
Title
Depression level on the Hamilton scale
Description
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
Time Frame
One month
Secondary Outcome Measure Information:
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure
Title
Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz
Description
Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.
Time Frame
Three months between the first and second measure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Estalayo-Gutierrez, MD, PhD
Organizational Affiliation
University of Alcalá
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alcalá
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26439515
Citation
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.
Results Reference
background
PubMed Identifier
16168732
Citation
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.
Results Reference
background

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Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

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