Skip to main content
OpenTrials
Completed

NCT Number: NCT05441891

Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asymmetric Sensorineural Hearing Loss Mental Disorders

Age range

31 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory intervention filter-modulated group

Other

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

Primary outcomes

  1. Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 125 Hz measured in an air conduction pure tone audiometry

  2. Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 250 Hz measured in an air conduction pure tone audiometry

  3. Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 500 Hz measured in an air conduction pure tone audiometry

  4. Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 750 Hz measured in an air conduction pure tone audiometry

  5. Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 1000 Hz measured in an air conduction pure tone audiometry

  6. Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 1500 Hz measured in an air conduction pure tone audiometry

  7. Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 2000 Hz measured in an air conduction pure tone audiometry

  8. Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 3000 Hz measured in an air conduction pure tone audiometry

  9. Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 4000 Hz measured in an air conduction pure tone audiometry

  10. Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 6000 Hz measured in an air conduction pure tone audiometry

  11. Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months

    Time frame: Change from Baseline hearing threshold at 3 months

    Minimum number of decibels needed to hear a sound at a frequency of 8000 Hz measured in an air conduction pure tone audiometry

  12. Anxiety and depression level on the Goldberg scale

    Time frame: One month

    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

  13. Anxiety level on the Hamilton scale

    Time frame: One month

    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).

  14. Depression level on the Hamilton scale

    Time frame: One month

    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 outcomes

  1. Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  2. Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  3. Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  4. Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  5. Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  6. Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  7. Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  8. Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  9. Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  10. Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

  11. Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz

    Time frame: Three months between the first and second measure

    Ratio of the threshold of one ear to that of the other. If both have the same threshold, the result is zero.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.