To understand how individuals with ringing sensation in the ears can shift attention away from the ringing in the ear, effortful listening abilities and measurement of fatigue.

Cognitive flexibility, listening effort, and its related fatigue in adults with tinnitus â?? An exploratory study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/01/048681

Enrollment

276

Registered

2023-01-02

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H838- Other specified diseases of innerear

Interventions

Control Intervention1: nil: nil Control Intervention2: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Phase 1 - Participants who are native Kannada speakers, or non-native Kannada speakers with self-reported good to excellent language skills - Individuals with tinnitus (present in one or both ears), hearing loss (with and without tinnitus) - Individuals with hearing loss whose hearing acuity ranges from mild to severe Phase 2 (Group 1) - Participants who are native Kannada speakers, or non-native Kannada speakers with self-reported good to excellent language skills - Participants with hearing sensitivity - Phase 2 (Group 2) - Participants with hearing sensitivity - Individuals who are age and gender-matched to Group 1 - Montreal Cognitive Assessment (MoCA) scores greater than 26 (out of 30) - Participants should have normal middle ear functioning which will be confirmed using Interacoustics AT235H middle ear analyzer. - Participants with normal outer hair cell functioning.

Exclusion criteria

Exclusion criteria: Phase 1 - Any diagnosed neurological or psychological impairments. Phase 2 - Participants with hearing sensitivity - Individuals who are age and gender-matched to Group 1 - Montreal Cognitive Assessment (MoCA) scores greater than 26 (out of 30) - Participants should have normal middle ear functioning which will be confirmed using Interacoustics AT235H middle ear analyzer. - Participants with normal outer hair cell functioning.

Design outcomes

Primary

Measure	Time frame
Phase I - Content validation - Convergent validation - Exploratory factor analysis - Item Response Theory Phase II Behavioral measures - Vanderbilt Fatigue Scale for Adults in Kannada: total scores - Listening-related fatigue measures - Task-switching paradigm - Psychomotor vigilance test Electrophysiological measures - Listening-related fatigue task: EEG alpha power in microvolt - Task-switching paradigm: Cue-locked switch positivity latency in milliseconds and amplitude in microvolt - Psychomotor vigilance test: Late positivity potentials latency in millisecond in microvolt.Timepoint: Phase I - Content validation - Convergent validation - Exploratory factor analysis - Item Response Theory Time points - 6 months Phase II Behavioral measures time points - 3 months electrophysiological measures time points - 6 months	—

Measure

Time frame

Phase I - Content validation - Convergent validation - Exploratory factor analysis - Item Response Theory Phase II Behavioral measures - Vanderbilt Fatigue Scale for Adults in Kannada: total scores - Listening-related fatigue measures - Task-switching paradigm - Psychomotor vigilance test Electrophysiological measures - Listening-related fatigue task: EEG alpha power in microvolt - Task-switching paradigm: Cue-locked switch positivity latency in milliseconds and amplitude in microvolt - Psychomotor vigilance test: Late positivity potentials latency in millisecond in microvolt.Timepoint: Phase I - Content validation - Convergent validation - Exploratory factor analysis - Item Response Theory Time points - 6 months Phase II Behavioral measures time points - 3 months electrophysiological measures time points - 6 months

—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDr Hari Prakash P

Manipal College of Health Professions (MCHP)

hari.prakash@manipal.edu9886135522

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026