Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

University of Alcala

Status: Completed

Conditions: Asymmetric Sensorineural Hearing Loss

Treatments: Other: Auditory intervention filter-modulated group

Study type: Interventional

Funder types: Other

Identifiers

NCT05441891

CREC/UH/2022/05

Details and patient eligibility

About

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.

Full 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).

Enrollment: 233 patients

Sex: All

Ages: 31 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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233 participants in 2 patient groups

Control group

No Intervention group

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.

Auditory intervention filter-modulated

Active Comparator group

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).

Treatment:

Other: Auditory intervention filter-modulated group