MedTrace Logo

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

NCT02772536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-01-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Leicester Royal Infirmary NHS Trust

    collaborator OTHER

  • University of Leicester

    lead OTHER

Principal Investigators

  • Michael Mulheran, PhD · University of Leicester

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-10
Primary Completion
2017-12-09
Completion
2017-12-09

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02772536 on ClinicalTrials.gov