The Mental Cost and Burden of Listening

NCT06951815 | Completed

• 1 other identifier: 2024-21234-37958
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised controlled trial aims to test the effect of hearing adjustment using hearing aids, on the ease and effectiveness of communication such as listening effort, fatigue, and sentence recognition in noise, in addition to wellbeing and sleep; and to reveal the role of cognitive resources and sleep efficiency in this relationship.

Conditions

Quality of Life (QOL); Communication Barriers; Cognitive Performance; Fatigue, Mental

Keywords

Cognitive resource depletion; hearing handicap; hearing loss; listening effort; mental fatigue; ease of communication; sleep efficiency

Outcome Measures

Primary Outcomes (1)

• Subjective Listening-related Mental Fatigue

  Subjective listening-related mental fatigue is measured using the Visual Analogue Fatigue Scale at the end of a long listening exercise reworded to reflect listening-related fatigue. It is a one-item scale from 0 to 10, with higher scores indicating more fatigue. This will be measured before the intervention and 4 weeks after, and the analysis will focus on the post-intervention score while controlling for the pre-intervention score.

  From enrolment to the end of the trial at 6 weeks

Secondary Outcomes (1)

• Subjective Listening-related Effort

  From enrolment to the end of the trial at 6 weeks

Other Outcomes (4)

• Sentence Recognition in Noise

  From enrolment to the end of the trial at 6 weeks

• Objective Cognitive Resource Availability

  From enrolment to the end of the trial at 6 weeks

• Objective Sleep Efficiency

  From enrolment to the end of the trial at 6 weeks

Study Arms (2)

Hearing Aid Group

EXPERIMENTAL

This group will be fitted with hearing aids and will be the intervention group.

Device: Hearing aids programmed to each participant's hearing loss.

Information Session Control Group

NO INTERVENTION

This group will receive an information session during the time that the experimental group receives the hearing-aid fitting about available hearing care solutions.

Interventions

Hearing aids programmed to each participant's hearing loss. DEVICE

This study is not investigating the efficacy of hearing aids, rather it is investigating the effect of adjusting hearing on cognitive resources, listening effort, and fatigue.

Hearing Aid Group

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 or older
• Hearing aid candidate (hearing loss of an average of 25 dB HL or worse)
• Novice to hearing aids

You may not qualify if:

• Younger than 60
• Normal hearing
• Already uses hearing aids

Sponsors & Collaborators

• University of Manchester: lead
• Sonova AG: collaborator

Study Sites (1)

Manchester Centre for Audiology and Deafness

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Mental Fatigue; Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Karolina Kluk de-Kort, Doctorate

  University of Manchester

  STUDY DIRECTOR

• Antje Heinrich, Doctorate

  University of Manchester

  STUDY DIRECTOR

• Josef Schlittenlacher, Doctorate

  University of Manchester

  STUDY DIRECTOR

• Stephanie Loukieh, Masters Degree

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Raffael Schmitt, Doctorate

  Sonova AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Concealed allocation prevents the recruiter and data collector from knowing the assignment of each participant before the fitting session.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The study will include 2 groups of older adult hearing aid candidates, one will receive a hearing aid intervention (the test group) and one will attend an explanation session instead (the control group) and they will be randomly assigned. Interested participants will be prescreened over the phone before being invited to the lab for official recruitment. Participants will be invited into the lab if they meet the age requirement (60 or above), get a positive screen in the RHHI-S (6 or above) and meet the condition of having no prior hearing aid experience. Participants will be randomly assigned in parallel as enrolment occurs with a biological sex balance. To achieve the randomisation element while still being able to assign as they enrol and maintain biological sex balance, stratified block randomisation will be used with a predetermined random assignment list attached here. Both groups will have a pre-test and a post-test.

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 30, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)