MedDataX Logo

Role of Exposure in Hyperacusis

NCT ID: NCT04705246

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-07

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperacusis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Psychoeducation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universiteit Antwerpen

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Laure Jacquemin, PhD

Role: CONTACT

Phone: 038214233

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22443320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28448659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28669224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20515235 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Exposure in Hyperacusis

Identifier Type: -

Identifier Source: org_study_id