Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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