Role of Exposure in Hyperacusis

Hyperacusis Clinical Trial

Official title:

Effect of Psychoeducation Upon Exposure to Sounds and Hyperacusis Severity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04705246
• Other study ID #: Exposure in Hyperacusis
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 7, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Antwerp
• Contact: Laure Jacquemin, PhD
• Phone: 038214233
• Email: laure_jacquemin[@]uza.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. For the period of one month, hyperacusis and tinnitus severity and exposure to sounds will be evaluated by use of Ecological Momentary Assessment (EMA) in all participants. A novel approach to assessments, EMA prompts participants during their daily life to answer short questionnaires, increasing ecological validity and minimizing the risk for recall and memory biases. At a randomized time point during the one-month period, participants will individually receive a single psychoeducation session (1h) delivered by an experienced audiologist. The goal of the study is to investigate if the psychoeducation session leads to an increase in exposure to sound and a decrease in hyperacusis severity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary complaint of hyperacusis

Exclusion Criteria:

• primary complaint of misophonia

• primary complaint of tinnitus

• undergoing another therapy at the moment of the study

Related Conditions & MeSH terms

• Hyperacusis

Intervention

Behavioral:
• Psychoeducation
The goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Blaesing L, Kroener-Herwig B. Self-reported and behavioral sound avoidance in tinnitus and hyperacusis subjects, and association with anxiety ratings. Int J Audiol. 2012 Aug;51(8):611-7. doi: 10.3109/14992027.2012.664290. Epub 2012 Mar 24. — View Citation

Goldberg RL, Piccirillo ML, Nicklaus J, Skillington A, Lenze E, Rodebaugh TL, Kallogjeri D, Piccirillo JF. Evaluation of Ecological Momentary Assessment for Tinnitus Severity. JAMA Otolaryngol Head Neck Surg. 2017 Jul 1;143(7):700-706. doi: 10.1001/jamaoto.2017.0020. — View Citation

Henry JA, Thielman E, Zaugg T, Kaelin C, Choma C, Chang B, Hahn S, Fuller B. Development and field testing of a smartphone "App" for tinnitus management. Int J Audiol. 2017 Oct;56(10):784-792. doi: 10.1080/14992027.2017.1338762. Epub 2017 Jul 2. — View Citation

Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in EMA questions from baseline to end of the study	Change in questions concerning exposure, hyperacusis and tinnitus during the day from baseline measurement to last day of the study period	8 random time points each day during the period of the study, from baseline and after intervention, though study completion for an average of 1 month
Secondary	Hyperacusis Questionnaire	Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.	before intervention, immediately post intervention
Secondary	Tinnitus Functional Index (TFI)	Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus	before intervention, immediately post intervention