Clinical trial NCT05441891: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asymmetric Sensorineural Hearing Loss
Keywords: hearing asymmetry
mental disorders
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 233
Sex: ALL
Minimum age (years): 31
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel, pre-post study design
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Change from Baseline hearing threshold at a frequency of 125 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 250 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 500 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 750 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 1000 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 1500 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 2000 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 3000 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 4000 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 6000 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Change from Baseline hearing threshold at a frequency of 8000 Hz in an air conduction pure tone audiometry at three months
timeFrame: Change from Baseline hearing threshold at 3 months
measure: Anxiety and depression level on the Goldberg scale
timeFrame: One month
measure: Anxiety level on the Hamilton scale
timeFrame: One month
measure: Depression level on the Hamilton scale
timeFrame: One month
Secondary outcomes:
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 125 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 250 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 500 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 750 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 1000 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 1500 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 2000 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 3000 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 4000 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 6000 Hz
timeFrame: Three months between the first and second measure
measure: Relationship between the auditory threshold of the right and left ear at the frequency of 8000 Hz
timeFrame: Three months between the first and second measure
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
affiliation: University of Alcalá
name: Beatriz Estalayo-Gutierrez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.