Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

NCT05441891 | Completed DMC

• 1 other identifier: CREC/UH/2022/05
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Asymmetric Sensorineural Hearing Loss

Keywords

hearing asymmetry; mental disorders

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (11)

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

  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

  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

  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

  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

  Three months between the first and second measure

Study Arms (2)

Control group

NO INTERVENTION

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.

Auditory intervention filter-modulated

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Bérard´s method

Auditory intervention filter-modulated

Eligibility Criteria

• Age: 31 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Having significant hearing loss
• Having acute otological process
• Having psychotic disease
• Having epilepsy
• Having serious illness
• Having pregnancy
• Used to try alcohol or drugs

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

University of Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (2)

• 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.

  PMID: 26439515 BACKGROUND

• 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.

  PMID: 16168732 BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Beatriz Estalayo-Gutierrez, MD, PhD

  University of Alcalá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants not received any intervention. The researchers in charge of outcome assessment and statistical analysis are blinded to the allocation of participants
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, parallel, pre-post study design

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 1, 2022
• Study Start: June 17, 2022
• Primary Completion: October 19, 2022
• Study Completion: October 21, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)