Exploratory Study on the Role of Somatic Modulation in Hyperacusis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04693819

Enrollment

Registered

2021-01-05

Start date

2020-12-07

Completion date

2021-12-31

Last updated

2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperacusis

Keywords

Hyperacusis, Somatic, Modulation

Brief summary

This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound' and is commonly associated with tinnitus. The effects of somatic modulation upon tinnitus have been studied, but not so for hyperacusis.. The effect of 9 somatic modulations (i.e. 3 jaw modulations and 6 cervical spine modulations) and 1 control movement (i.e. without any somatic modulation effect) in random order on the sound tolerance of a 1 kilohertz (kHz) broadband noise sound and the tinnitus experience will be investigated. More specifically, the perceived loudness and intrusiveness of this sound and the tinnitus sound will be evaluated before somatic modulation and during the somatic modulation.

Interventions

DIAGNOSTIC_TESTSomatic modulation

Type of modulations: 3 jaw and 6 cervical spine modulations, 1 control movement (i.e. without any expected somatic modulation effect) Jaw modulations: laterotrusion to the left, laterotrusion to the right and protrusion Cervical spine modulations: isometric flexion, extension and left and right lateroflexion of the head against resistance of the investigator's hand, compression and traction of the cervical spine in sitting position. Control movement: the investigator's hand rests against the patient's forehead without any force application

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary complaint of hyperacusis

Exclusion criteria

* Primary complaint of tinnitus

Design outcomes

Primary

Measure	Time frame	Description
Change in rating of hyperacusis (loudness and intrusiveness) after modulation	Baseline (Before modulation), Immediately after modulation	Change in hyperacusis loudness and intrusiveness rating by use of a visual analogue scale

Secondary

Measure	Time frame	Description
Change in rating of tinnitus (loudness and intrusiveness) after modulation	Baseline (Before modulation), Immediately after modulation	Change in tinnitus loudness and intrusiveness rating by use of a visual analogue scale

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026