Exploratory Study on the Role of Somatic Modulation in Hyperacusis

Hyperacusis Clinical Trial

Official title:

Exploratory Study on the Role of Somatic Modulation in Hyperacusis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693819
• Other study ID #: SomHyp
• Status: Completed
• Start date: December 7, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2021
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary complaint of hyperacusis

Exclusion Criteria:

• Primary complaint of tinnitus

Related Conditions & MeSH terms

• Hyperacusis

Intervention

Diagnostic Test:
• Somatic 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

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Baguley DM, Hoare DJ. Hyperacusis: major research questions. HNO. 2018 May;66(5):358-363. doi: 10.1007/s00106-017-0464-3. Review. — View Citation

Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. Review. — View Citation

Shore SE. Plasticity of somatosensory inputs to the cochlear nucleus--implications for tinnitus. Hear Res. 2011 Nov;281(1-2):38-46. doi: 10.1016/j.heares.2011.05.001. Epub 2011 May 18. Review. — View Citation

Outcome

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