TinnitusNCT02772536
A Clinical Trial Investigating Effect of Tinted Light on Perception of Tinnitus
A study testing Visual Stimulus Condition Set in people with Tinnitus, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Background An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that viewing particular tints of light appeared to result in some improvement of their tinnitus. This ameliorative effect appeared to be primarily acute and only reported to occur whilst viewing the tint. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- Visual Stimulus Condition Set
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Mar 2015to 9 Dec 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 + years
- Not receiving other tinnitus therapy or involved in any other tinnitus trial
- To be in reasonable or good general health
- Willing and able to give informed consent for participation in the study
- Able to understand simple verbal explanation in English
- Able to provide simple clear verbal feedback in English
Who cannot join
- Aged under 18 yrs
- Suffering only acute occasional tinnitus or non-intrusive tinnitus
- Any serious illness that may adversely affect participation for example cancer, dementia/neurodegenerative illness, psychoses, stroke
- Receiving other treatments for tinnitus during the trial
- Unable or unwilling to give consent
- Unable to understand or speak English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester Royal Infirmary University Hospitals Trust
Leicester, Leicestershire, LE1 5WW
About this study
Official title: An Open Design Clinical Trial Investigating the Effect of Tinted Light on Perception of Tinnitus to Establish Its Efficacy
Background
An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that viewing particular tints of light appeared to result in some improvement of their tinnitus.
Read more
This ameliorative effect appeared to be primarily acute and only reported to occur whilst viewing the tint. Individual patients would choose differing tints with some identifying more than one tint that affected their tinnitus.
Aim of the Study
In this current basic science study, the aim is to provide preliminary data to return estimates of the efficacy of using tinted light to ameliorate tinnitus.
After identification of responders during screening, responders are invited to attend three further trial sessions, where their tinnitus is assessed in response to three luminance conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light.
The response to low ambient light serves as a control to compare the effect of tinted light against and the response to white light serves as an 'active' stimulus comparator.
These results will then establish whether tinted light provides patients with a useful improvement in their tinnitus compared with measures of their baseline tinnitus obtained in the dark and against a standardised white light stimulus.
They will also inform further development of the technique as a potential treatment for tinnitus in responsive patients.
Over the three sessions, the averaged responses given by the patient under each stimulus condition will be analysed to provide a measure of efficacy.
Read the detailed description
Study Protocol
The overall study design is open, as participants are explicitly required to identify a specific light tint that they perceive as affecting the annoyance or intrusiveness of their tinnitus. An element of an active control is provided by reference to changes reported with a self-selected tint referenced against white light. The a priori assumption is that with this optically defined white light, the reported changes in tinnitus will remain as zero. The following is a protocol outline of the trial as experienced by participants. All trial data is anonymised with hard copies securely held at the trial site.
Invitation to participate and seeking consent
First Visit:
Questionnaires and Screening for identifying Tinnitus patients reporting their whose perception of tinnitus is changed by tinted light .
Trial Questionnaires Following consent to take part in the study, at the first visit the participant completes two questionnaires. This provides relevant baseline demographics, history of general health tinnitus and hearing. The second questionnaire is the Oregon Tinnitus Functional Index (TFI) to assess the impact of tinnitus on the participant's life.
Light Test Screening:
Identification of Tints Affecting Tinnitus Perception The following all take place in a sound proof room at the Leicester Royal Infirmary in which the participant is comfortably seated during the session.
After an explanation of what will be asked of them, the patient is asked to provide Tinnitus Annoyance and Tinnitus Loudness VAS values to serve as baseline measurements.
The only sources of illumination during the experimental procedure are from the Light Emitting Diode (LED) lamp in front of the patient and indirect low level ambient illumination from a laptop screen. The laptop screen is viewed by the experimenter and its display cannot be seen by the participant.
The LED lamp consists of three banks of Red, Green and Blue (RGB) LEDs under direct manual and computer control. The Lamp head projects down onto an A4 sized platen that forms the base of the lamp. On this platen base, an A4 sheet of white paper is illuminated by the calibrated output of the RGB LED.
The participant is then comfortably seated and asked to look at the default setting of white illuminated by the calibrated LED lamp. This is at a distance of about 45-50 cm. The participant then controls the colour output of the LED lamp by varying three independent manual dials, one each for the Red, Green and Blue LEDs to produce a very wide range of light tints. A demonstration and practice with explanation by the experimenter is provided prior to commencing this procedure.
During the screening procedure, the patient is asked to report if any of the tints they see appears to improve their tinnitus. The individual RGB values for each tint reported by the participant are recorded by the experimenter.
The degree of improvement is estimated by the patient reporting Tinnitus Annoyance and Loudness VAS ratings as described below and a Clinical Global Index (CGI) value as described below.
If they do identify one or more tinnitus ameliorating tints, then they are invited to replicate this again and the settings return to the default optical white. The RGB dials do not have any calibration marking, but are connected to a laptop that monitors the colour space generated.
This is under experimenter control. The individual RGB values for each tint reported by the participant are again recorded by the experimenter along with the two Tinnitus VAS and a CGI value.
The experimenter also establishes if the chosen tint can be replicated independently under computer control by gradually changing the RGB values to replicate the tint(s) along with the recording of VAS and CGI values as described above.
Importantly, no verbal feedback by the experimenter about tint choice is given and the only guide assumed to be active in tint choice is effect on the participants tinnitus.
Once replication has been established at the first screening session the participant is then invited to attend a further three sessions to provide evidence of stability of longer term effect necessary to demonstrate efficacy.
Second to Fourth Visit: Estimating Efficacy On these visits, the participant is invited back into the soundproof room and is seated comfortably in front of the LED lamp.
At the start of the second session, patients are asked to provide their baseline VAS ratings for tinnitus loudness and annoyance. At this second visit, the patient is then invited to choose what they consider to be their optimal tint fro improving their tinnitus as they did at the first visit.
The optimal tint affecting their tinnitus is then replicated by both the patient and independently by the experimenter.
Once they have confirmed their optimal choice, the setting is noted by the experimenter for presentation.
The patient is then presented with three sets of visual stimulus condition to assess efficacy.
Low level ambient lighting: - Under low level illumination patients will be asked to provide VAS and CGI ratings for their tinnitus on three occasions over 10 minutes at 0,5 and 10 mins. These values are recorded by the experimenter.
Optimal tint - Patients will view their optimal light tint presented for 20 minutes and asked to provide VAS and CGI ratings on three occasions at 5, 10 and 15 mins. At 0 and 20 mins, i.e. just before and just after the optimal tint is presented, they are asked to provide these values under conditions of low ambient illumination. These values are recorded by the experimenter.
White Light - After a few minutes interval, patients are asked to repeat the above procedure but whilst viewing white light that serves as an active comparator. These values are recorded by the experimenter.
The third and fourth visits are ideally spaced at two weekly intervals, but timings of the visits are arranged to fit with the lifestyle and commitments of the patients.
At these visits, the patients are again invited to provide VAS and CGI scores to the three illumination conditions described above.
Once a full set of data from the four visits has been obtained, the patient has completed their participation in the trial. The VAS and CGI measurements obtained are then further processed to return primary and secondary outcome measures for each patient at the end of their participation in the trial.
- Conditions
- Tinnitus
- Being tested
- Visual Stimulus Condition Set
- Keywords
- Chronic Tinnitus Tinted Light Change in Perception
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Stimulus Condition SetOther
In this single arm study, all participants are subject to a set of three visual stimulus conditions.
Low ambient light for 10 mins: Self selected tinted light (20 Mins); White light (20 mins).
VAS/CGI scores for each stimulus condition in the above set are reported at five minute intervals.
| Study group | Role | What they receive |
|---|---|---|
| Visual Stimulus Condition Set | Other | In this single arm study all participants are subject to a set of three visual stimulus conditions.
These are: Low ambient light; Self selected tinted light; White light Receives: Other: Visual Stimulus Condition Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Averaged difference between dark and optimal tint tinnitus annoyance Visual Analogue Score (VAS)
As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides tinnitus annoyance VAS values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light). At the end of each visit, the tinnitus annoyance VAS for the different visual stimulus conditions is then averaged. The difference between the averaged annoyance VAS for dark and the optimal light tint is calculated for each visit.
After the final visit, the difference between the dark and optimal light tint conditions over all three visits is then averaged. This averaged difference in tinnitus annoyance over all three visits is then used as the primary outcome measure for the study.
Measured: At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.
Secondary outcomes (1)
Averaged difference between dark and optimal tint tinnitus loudness Visual Analogue Score (VAS)
As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides tinnitus loudness VAS values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light).
At the end of each visit, the tinnitus loudness VAS for the different visual stimulus conditions is then averaged. The difference between the averaged loudness VAS for dark and the optimal light tint is calculated for each visit.
After the final visit, the difference between the dark and optimal light tint conditions over all three visits is then averaged. This averaged difference in tinnitus loudness over all three visits is then used as a secondary outcome measure for the study.
Measured: At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start10 Mar 2015
- Primary completion9 Dec 2017
- Study completion9 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Leicester Royal Infirmary NHS Trust
- Responsible party
- Sponsor
- Investigators
- Michael Mulheran, PhD, Study director, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772536
- Sponsor's protocol ID
- 0473
- Status last verified
- Jan 2020
- First submitted
- 4 May 2016
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Design Clinical Trial Investigating the Effect of Tinted Light on Perception of Tinnitus to Establish Its Efficacy
- ClinicalTrials.gov ID
- NCT02772536
- Acronym / sponsor ID
- 0473
- Conditions
- Tinnitus
- Keywords
- Chronic Tinnitus Tinted Light Change in Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Leicester Royal Infirmary NHS Trust
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 9 Dec 2017 (actual)
- Study completion
- 9 Dec 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- 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.
Background
An earlier pilot study provided evidence that about 40% of tinnitus sufferers reported that viewing particular tints of light appeared to result in some improvement of their tinnitus.
This ameliorative effect appeared to be primarily acute and only reported to occur whilst viewing the tint. Individual patients would choose differing tints with some identifying more than one tint that affected their tinnitus.
Aim of the Study
In this current basic science study, the aim is to provide preliminary data to return estimates of the efficacy of using tinted light to ameliorate tinnitus.
After identification of responders during screening, responders are invited to attend three further trial sessions, where their tinnitus is assessed in response to three luminance conditions: Low Ambient Light; Tint of Light affecting Tinnitus; White Light.
The response to low ambient light serves as a control to compare the effect of tinted light against and the response to white light serves as an 'active' stimulus comparator.
These results will then establish whether tinted light provides patients with a useful improvement in their tinnitus compared with measures of their baseline tinnitus obtained in the dark and against a standardised white light stimulus.
They will also inform further development of the technique as a potential treatment for tinnitus in responsive patients.
Over the three sessions, the averaged responses given by the patient under each stimulus condition will be analysed to provide a measure of efficacy.
Detailed description
Study Protocol
The overall study design is open, as participants are explicitly required to identify a specific light tint that they perceive as affecting the annoyance or intrusiveness of their tinnitus. An element of an active control is provided by reference to changes reported with a self-selected tint referenced against white light. The a priori assumption is that with this optically defined white light, the reported changes in tinnitus will remain as zero. The following is a protocol outline of the trial as experienced by participants. All trial data is anonymised with hard copies securely held at the trial site.
Invitation to participate and seeking consent
First Visit:
Questionnaires and Screening for identifying Tinnitus patients reporting their whose perception of tinnitus is changed by tinted light .
Trial Questionnaires Following consent to take part in the study, at the first visit the participant completes two questionnaires. This provides relevant baseline demographics, history of general health tinnitus and hearing. The second questionnaire is the Oregon Tinnitus Functional Index (TFI) to assess the impact of tinnitus on the participant's life.
Light Test Screening:
Identification of Tints Affecting Tinnitus Perception The following all take place in a sound proof room at the Leicester Royal Infirmary in which the participant is comfortably seated during the session.
After an explanation of what will be asked of them, the patient is asked to provide Tinnitus Annoyance and Tinnitus Loudness VAS values to serve as baseline measurements.
The only sources of illumination during the experimental procedure are from the Light Emitting Diode (LED) lamp in front of the patient and indirect low level ambient illumination from a laptop screen. The laptop screen is viewed by the experimenter and its display cannot be seen by the participant.
The LED lamp consists of three banks of Red, Green and Blue (RGB) LEDs under direct manual and computer control. The Lamp head projects down onto an A4 sized platen that forms the base of the lamp. On this platen base, an A4 sheet of white paper is illuminated by the calibrated output of the RGB LED.
The participant is then comfortably seated and asked to look at the default setting of white illuminated by the calibrated LED lamp. This is at a distance of about 45-50 cm. The participant then controls the colour output of the LED lamp by varying three independent manual dials, one each for the Red, Green and Blue LEDs to produce a very wide range of light tints. A demonstration and practice with explanation by the experimenter is provided prior to commencing this procedure.
During the screening procedure, the patient is asked to report if any of the tints they see appears to improve their tinnitus. The individual RGB values for each tint reported by the participant are recorded by the experimenter.
The degree of improvement is estimated by the patient reporting Tinnitus Annoyance and Loudness VAS ratings as described below and a Clinical Global Index (CGI) value as described below.
If they do identify one or more tinnitus ameliorating tints, then they are invited to replicate this again and the settings return to the default optical white. The RGB dials do not have any calibration marking, but are connected to a laptop that monitors the colour space generated.
This is under experimenter control. The individual RGB values for each tint reported by the participant are again recorded by the experimenter along with the two Tinnitus VAS and a CGI value.
The experimenter also establishes if the chosen tint can be replicated independently under computer control by gradually changing the RGB values to replicate the tint(s) along with the recording of VAS and CGI values as described above.
Importantly, no verbal feedback by the experimenter about tint choice is given and the only guide assumed to be active in tint choice is effect on the participants tinnitus.
Once replication has been established at the first screening session the participant is then invited to attend a further three sessions to provide evidence of stability of longer term effect necessary to demonstrate efficacy.
Second to Fourth Visit: Estimating Efficacy On these visits, the participant is invited back into the soundproof room and is seated comfortably in front of the LED lamp.
At the start of the second session, patients are asked to provide their baseline VAS ratings for tinnitus loudness and annoyance. At this second visit, the patient is then invited to choose what they consider to be their optimal tint fro improving their tinnitus as they did at the first visit.
The optimal tint affecting their tinnitus is then replicated by both the patient and independently by the experimenter.
Once they have confirmed their optimal choice, the setting is noted by the experimenter for presentation.
The patient is then presented with three sets of visual stimulus condition to assess efficacy.
Low level ambient lighting: - Under low level illumination patients will be asked to provide VAS and CGI ratings for their tinnitus on three occasions over 10 minutes at 0,5 and 10 mins. These values are recorded by the experimenter.
Optimal tint - Patients will view their optimal light tint presented for 20 minutes and asked to provide VAS and CGI ratings on three occasions at 5, 10 and 15 mins. At 0 and 20 mins, i.e. just before and just after the optimal tint is presented, they are asked to provide these values under conditions of low ambient illumination. These values are recorded by the experimenter.
White Light - After a few minutes interval, patients are asked to repeat the above procedure but whilst viewing white light that serves as an active comparator. These values are recorded by the experimenter.
The third and fourth visits are ideally spaced at two weekly intervals, but timings of the visits are arranged to fit with the lifestyle and commitments of the patients.
At these visits, the patients are again invited to provide VAS and CGI scores to the three illumination conditions described above.
Once a full set of data from the four visits has been obtained, the patient has completed their participation in the trial. The VAS and CGI measurements obtained are then further processed to return primary and secondary outcome measures for each patient at the end of their participation in the trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Stimulus Condition Set | Other | Other: Visual Stimulus Condition SetIn this single arm study all participants are subject to a set of three visual stimulus conditions. These are: Low ambient light; Self selected tinted light; White light |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 + years
- Not receiving other tinnitus therapy or involved in any other tinnitus trial
- To be in reasonable or good general health
- Willing and able to give informed consent for participation in the study
- Able to understand simple verbal explanation in English
Key exclusion criteria (6 listed)
- Aged under 18 yrs
- Suffering only acute occasional tinnitus or non-intrusive tinnitus
- Any serious illness that may adversely affect participation for example cancer, dementia/neurodegenerative illness, psychoses, stroke
- Receiving other treatments for tinnitus during the trial
- Unable or unwilling to give consent
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 |
|---|---|---|
| Visual Stimulus Condition SetIn this single arm study, all participants are subject to a set of three visual stimulus conditions. Low ambient light for 10 mins: Self selected tinted light (20 Mins); White light (20 mins). VAS/CGI scores for each stimulus condition in the above set are reported at five minute intervals. | Other | Visual Stimulus Condition Set |
Primary outcome
Averaged difference between dark and optimal tint tinnitus annoyance Visual Analogue Score (VAS)
Time frame: At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.
As described in the protocol, during the efficacy phase of the trial, the participant attends clinic on three occasions. At each visit, the participant provides tinnitus annoyance VAS values at set time points during the presentation of the three visual stimulus conditions (dark, optimal light tint, white light). At the end of each visit, the tinnitus annoyance VAS for the different visual stimulus conditions is then averaged. The difference between the averaged annoyance VAS for dark and the optimal light tint is calculated for each visit. After the final visit, the difference between the dark and optimal light tint conditions over all three visits is then averaged. This averaged difference in tinnitus annoyance over all three visits is then used as the primary outcome measure for the study.
1 secondary outcome
Averaged difference between dark and optimal tint tinnitus loudness Visual Analogue Score (VAS)
Time frame: At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.
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 30 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Michael Mulheran, PhD study director
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Stimulus Condition Set in people with Tinnitus, run by University of Leicester at 1 site in United Kingdom.
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 6 inclusion and 6 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 30 Jan 2020. 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 United Kingdom. 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?
Averaged difference between dark and optimal tint tinnitus annoyance Visual Analogue Score (VAS) (time frame: At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2020.