Hearing Loss, Age-RelatedNCT07071168
Hearing-physical Activity Intervention
A study testing hearing-physical activity training in people with Hearing Loss, Age-Related, run by The Hong Kong Polytechnic University.
Trial summary
Background By 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social engagement, increased depressive symptoms, cognitive decline and a higher risk of dementia. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Age-Related
- What is being tested?
- hearing-physical activity training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria are: (1) ethnic Chinese aged 60 years and above living at home; (2) with mild to moderate hearing loss diagnosed by a pure-tone average of 20 to 50 dB across octave frequencies 0.5 to 4kHz in both ears; and (3) no cognitive impairment [score of ≦2 on the 5-item Abbreviated Memory Inventory for the Chinese (AMIC)].
The exclusion criteria include: (1) those with a diagnosis of a major neurocognitive disorder; (2) a history of symptomatic stroke or other disease of the central nervous system; 3) a serious medical or psychiatric illness (e.g., severe depression, schizophrenia, bi-polar disorder) or a visual impairment that would interfere with using app.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing A Hearing-physical Activity Dual-task Training App for Older Adults With Hearing Loss: A Mixed Method Study
Background
By 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social engagement, increased depressive symptoms, cognitive decline and a higher risk of dementia. While previous studies highlight the benefits of combing hearing training and physical activity for older adults with ARHL, existing interventions are very limited. Additionally, the development of previous interventions often lacks end-user involvement, resulting in low adherence.
Read more
Objectives
This study aims to co-design a hearing-physical activity dual-task training app with older adults with ARHL, the potential end-users; to assess the feasibility and acceptability of the app using based on the theoretical framework of acceptability; and to examine its preliminary effects on improving physical activity, communication, loneliness, depressive symptoms and cognitive functions for older adults with age-related hearing loss.
Hypothesis to be tested
The app is feasible and acceptable to participants. Upon completing the 10-week intervention, the intervention group will report significantly greater improvements in physical activity, communication, loneliness, depressive symptoms and cognitive functions than the control group. These findings will support subsequent investigations in a larger-scale randomized controlled trial.
Research Design and Methods
This study consists of three phases. Phase 1: co-develop a prototype app that combines hearing and physical activity dual-task trainings, incorporating a music therapy component for older adults with ARHL. Co-design workshops will be conducted following the community-based participatory research methodology, where participants will engage in plenary and breakout sessions. Phase 2: conduct a two-arm, single-blinded, pilot randomized controlled trial. Phase 3: conduct individual semi-structured interviews immediately after the intervention. Four process evaluation outcomes will be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. Participants will include Chinese adults aged 60 years or older, with mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.
Main outcome measures Physical activity levels.
Data analysis
Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.
Expected results
A hearing-physical activity dual-task training app prototype, available in both Cantonese and Mandarin, will be co-designed, tested and refined to a final version. Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.
- Conditions
- Hearing Loss, Age-Related
- Being tested
- hearing-physical activity training
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing-physical activity trainingBehavioural
In this study, the intervention was designed to span 10 weeks. Based on our previous study, participants will attend hearing training 30 minutes/day, 5 days/week, The physical activity program will be performed at moderate intensity, 60 min/day, 3 days/week.39
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | A hearing-physical activity training Receives: Behavioral: hearing-physical activity training |
| Control group | Placebo comparator | waiting list group Receives: Behavioral: hearing-physical activity training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Physical activity levels (objectively): A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count. 44 Physical activity levels (subjectively): will be measured using the Chinese version of the 7-item International Physical Activity Questionnaire, which assesses the durations of time in the past 7 days that respondent stayed sedentary or engaged in ambulatory, moderate or vigorous physical activities. It has good psychometrics at the scale- and subscale- levels and significantly correlated with the objective physical activity measures.
Measured: 7 days
Secondary outcomes (4)
Loneliness
Loneliness will be measured using the 6-item De Jong Gierveld Loneliness Scale (Chinese version).47 It consists of two subscales: emotional loneliness and social loneliness. The scale has been validated and recommended as reliable (Cronbach's a=0.76, the intra-class correlation coefficients ranged from 0.98 to 1.00).
Measured: 2 weeks
Communication
Communication will be measured using Chinese version of the Hearing Handicap Inventory for the elderly (HHIE)48
Measured: 2 weeks
Depressive symptoms
Depressive symptoms will be measured by PHQ-9, which is a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression
Measured: 2 weeks
Cognitive function
Cognitive function will be measured by the Hong Kong-Montreal Cognitive Assessment (HK-MoCA).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHAO Yan Ivy, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071168
- Sponsor's protocol ID
- P0054427
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing A Hearing-physical Activity Dual-task Training App for Older Adults With Hearing Loss: A Mixed Method Study
- ClinicalTrials.gov ID
- NCT07071168
- Acronym / sponsor ID
- P0054427
- Conditions
- Hearing Loss, Age-Related
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background
By 2050, approximately 2.5 billion people are expected to experience some degree of age-related hearing loss (ARHL). Greater ARHL is associated with decreased communication, reduced physical activity and social engagement, increased depressive symptoms, cognitive decline and a higher risk of dementia. While previous studies highlight the benefits of combing hearing training and physical activity for older adults with ARHL, existing interventions are very limited. Additionally, the development of previous interventions often lacks end-user involvement, resulting in low adherence.
Objectives
This study aims to co-design a hearing-physical activity dual-task training app with older adults with ARHL, the potential end-users; to assess the feasibility and acceptability of the app using based on the theoretical framework of acceptability; and to examine its preliminary effects on improving physical activity, communication, loneliness, depressive symptoms and cognitive functions for older adults with age-related hearing loss.
Hypothesis to be tested
The app is feasible and acceptable to participants. Upon completing the 10-week intervention, the intervention group will report significantly greater improvements in physical activity, communication, loneliness, depressive symptoms and cognitive functions than the control group. These findings will support subsequent investigations in a larger-scale randomized controlled trial.
Research Design and Methods
This study consists of three phases. Phase 1: co-develop a prototype app that combines hearing and physical activity dual-task trainings, incorporating a music therapy component for older adults with ARHL. Co-design workshops will be conducted following the community-based participatory research methodology, where participants will engage in plenary and breakout sessions. Phase 2: conduct a two-arm, single-blinded, pilot randomized controlled trial. Phase 3: conduct individual semi-structured interviews immediately after the intervention. Four process evaluation outcomes will be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. Participants will include Chinese adults aged 60 years or older, with mild-to-moderate HL with a pure-tone average of 20-50 dB across octave frequencies 0.5 to 4kHz in both ears.
Main outcome measures Physical activity levels.
Data analysis
Descriptive statistics, an independent sample t-test or chi square test, generalized estimating equation and thematic analysis will be used.
Expected results
A hearing-physical activity dual-task training app prototype, available in both Cantonese and Mandarin, will be co-designed, tested and refined to a final version. Participants could benefit from incorporating tailored intervention for physical activity with auditory rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Behavioral: hearing-physical activity trainingA hearing-physical activity training |
| Control group | Placebo comparator | Behavioral: hearing-physical activity trainingwaiting list group |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hearing-physical activity trainingIn this study, the intervention was designed to span 10 weeks. Based on our previous study, participants will attend hearing training 30 minutes/day, 5 days/week, The physical activity program will be performed at moderate intensity, 60 min/day, 3 days/week.39 | Behavioural | Control group, Physical activity group |
Primary outcome
Physical activity
Time frame: 7 days
Physical activity levels (objectively): A wrist-worn ActiGraph GT3X+, valid step counter will be used to measure daily step-count. 44 Physical activity levels (subjectively): will be measured using the Chinese version of the 7-item International Physical Activity Questionnaire, which assesses the durations of time in the past 7 days that respondent stayed sedentary or engaged in ambulatory, moderate or vigorous physical activities. It has good psychometrics at the scale- and subscale- levels and significantly correlated with the objective physical activity measures.
4 secondary outcomes
Loneliness
Time frame: 2 weeks
Communication
Time frame: 2 weeks
Depressive symptoms
Time frame: 2 weeks
Cognitive function
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Age-Related
Not yet recruitingPhase 1/2
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Sensorineural Hearing Loss, Presbyacusis
Not yet recruitingObservational study
Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists
Hearing Loss, Age-Related, Presbycusis
Active, not recruiting
Hearing Healthcare Assessment in Rural Communities
Hearing Loss, Adult-Onset, Hearing Loss, Age-Related
Recruiting
Early Age-Related Hearing Loss Investigation (EARHLI)
Alzheimer Disease, Hearing Loss
Not yet recruiting
HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship
Hearing Loss, Hearing Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing hearing-physical activity training in people with Hearing Loss, Age-Related, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivy Zhao (27664550, yan-ivy.zhao@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.