HyperacusisNCT04693819
Exploratory Study on the Role of Somatic Modulation in Hyperacusis
An observational study of Hyperacusis, run by University Hospital, Antwerp at 1 site in Belgium.
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.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperacusis
- What is being tested?
- Somatic modulation
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Dec 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be aimed at adults experiencing a primary complaint of hyperacusis (i.e. abnormally reduced tolerance to sound).
Who may be able to join
- Primary complaint of hyperacusis
Who cannot join
- Primary complaint of tinnitus
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperacusis
- Being tested
- Somatic modulation
- Keywords
- Hyperacusis, Somatic, Modulation
- Medical subject headings
- Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic modulationDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Hyperacusis | Abnormally reduced tolerance to sound Receives: Diagnostic Test: Somatic modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rating of hyperacusis (loudness and intrusiveness) after modulation
Change in hyperacusis loudness and intrusiveness rating by use of a visual analogue scale
Measured: Baseline (Before modulation), Immediately after modulation
Secondary outcomes (1)
Change in rating of tinnitus (loudness and intrusiveness) after modulation
Change in tinnitus loudness and intrusiveness rating by use of a visual analogue scale
Measured: Baseline (Before modulation), Immediately after modulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start7 Dec 2020
- Primary completion19 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperacusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693819
- Sponsor's protocol ID
- SomHyp
- Status last verified
- Dec 2020
- First submitted
- 30 Dec 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21620940Baguley DM, Hoare DJ. Hyperacusis: major research questions. HNO. 2018 May;66(5):358-363. doi: 10.1007/s00106-017-0464-3.
PubMed 29392341Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.
PubMed 14645606Demoen S, Michiels S, Gilles A, Vermeersch H, Joossen I, Vanderveken OM, Lammers MJW, Timmermans A, Van Rompaey V, Baguley D, Jacquemin L. Pilot study on the role of somatic modulation in hyperacusis. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1425-1435. doi: 10.1007/s00405-022-07695-y. Epub 2022 Oct 13.
PubMed 36224398
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Role of Somatic Modulation in Hyperacusis
- ClinicalTrials.gov ID
- NCT04693819
- Acronym / sponsor ID
- SomHyp
- Conditions
- Hyperacusis
- Keywords
- Hyperacusis, Somatic, Modulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperacusis | – | Diagnostic Test: Somatic modulationAbnormally reduced tolerance to sound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be aimed at adults experiencing a primary complaint of hyperacusis (i.e. abnormally reduced tolerance to sound).
Key inclusion criteria (1 listed)
- Primary complaint of hyperacusis
Key exclusion criteria (1 listed)
- Primary complaint of tinnitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatic modulationType 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 | Diagnostic test | Hyperacusis |
Primary outcome
Change in rating of hyperacusis (loudness and intrusiveness) after modulation
Time frame: Baseline (Before modulation), Immediately after modulation
Change in hyperacusis loudness and intrusiveness rating by use of a visual analogue scale
1 secondary outcome
Change in rating of tinnitus (loudness and intrusiveness) after modulation
Time frame: Baseline (Before modulation), Immediately after modulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 21620940Shore 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.
- Background: PubMed 29392341Baguley DM, Hoare DJ. Hyperacusis: major research questions. HNO. 2018 May;66(5):358-363. doi: 10.1007/s00106-017-0464-3.
- Background: PubMed 14645606Baguley DM. Hyperacusis. J R Soc Med. 2003 Dec;96(12):582-5. doi: 10.1177/014107680309601203. No abstract available.
- Derived from this study: PubMed 36224398Demoen S, Michiels S, Gilles A, Vermeersch H, Joossen I, Vanderveken OM, Lammers MJW, Timmermans A, Van Rompaey V, Baguley D, Jacquemin L. Pilot study on the role of somatic modulation in hyperacusis. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1425-1435. doi: 10.1007/s00405-022-07695-y. Epub 2022 Oct 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperacusis, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in rating of hyperacusis (loudness and intrusiveness) after modulation (time frame: Baseline (Before modulation), Immediately after modulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693819, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.