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A Clinical Trial Investigating Effect of Tinted Light on Perception of Tinnitus

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ClinicalTrials.gov Identifier: NCT02772536
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
Leicester Royal Infirmary NHS Trust
Information provided by (Responsible Party):
University of Leicester

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Tinnitus Other: Visual Stimulus Condition Set Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Design Clinical Trial Investigating the Effect of Tinted Light on Perception of Tinnitus to Establish Its Efficacy
Actual Study Start Date : March 10, 2015
Actual Primary Completion Date : December 9, 2017
Actual Study Completion Date : December 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Visual Stimulus Condition Set

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

Other: Visual Stimulus Condition Set

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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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. ]

    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.



Other Outcome Measures:
  1. Averaged difference between dark and optimal tint Clinical Global Index Values [ Time Frame: At the end of the participation period in 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 CGI 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 CGI values for the different visual stimulus conditions are then averaged. The difference between the averaged CGI value dark and the optimal light tint is calculated for each visit.

    After the final visit, the difference in CGI values over the dark and optimal light tint conditions over all three visits is then averaged. This averaged CGI value difference over all three visits is then used as a further secondary outcome measure for the study.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772536


Locations
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United Kingdom
Leicester Royal Infirmary University Hospitals Trust
Leicester, Leicestershire, United Kingdom, LE1 5WW
Sponsors and Collaborators
University of Leicester
Leicester Royal Infirmary NHS Trust
Investigators
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Study Director: Michael Mulheran, PhD University of Leicester
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT02772536    
Other Study ID Numbers: 0473
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Leicester:
Chronic Tinnitus Tinted Light Change in Perception
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases