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

NCT02772536 | Completed

• 1 other identifier: 0473
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

Chronic Tinnitus Tinted Light Change in Perception

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  At the end of the participation period in the efficacy phase of trial, typically 4-6 weeks.

Other Outcomes (1)

• Averaged difference between dark and optimal tint Clinical Global Index Values

  At the end of the participation period in efficacy phase of trial, typically 4-6 weeks.

Study Arms (1)

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

Other: Visual Stimulus Condition Set

Interventions

Visual Stimulus Condition Set OTHER

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.

Visual Stimulus Condition Set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Leicester: lead
• Leicester Royal Infirmary NHS Trust: collaborator

Study Sites (1)

Leicester Royal Infirmary University Hospitals Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Mulheran, PhD

  University of Leicester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 13, 2016
• Study Start: March 10, 2015
• Primary Completion: December 9, 2017
• Study Completion: December 9, 2017
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)