CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
Experimental group intervention +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05772949
NCT05772949N/ACompleted

Effectiveness of a Smart Hearing Aid on Improving Psychosocial Well-being in Elderly: A Randomized-controlled Trial

The University of Hong Kong·interventional·Posted Mar 17, 2023·Updated Nov 29, 2023

In Brief

A clinical study evaluating Experimental group intervention and Wait-list control group intervention for Technology. Completed, enrolled 33 participants across 3 sites.

Detailed Summary

The study has 2 primary research questions, 4 secondary research questions, and 2 auxiliary research questions targeting elderly with hearing impairment. The research questions are: Primary study questions: 1. Can the use of the smart hearing aids reduce loneliness at the end of intervention? 2. Can the use of the smart hearing aids improve quality of life at the end of intervention? Secondary study questions: 3. Can the use of the smart hearing aids improve the communication quality between caregivers and participants at the end of intervention? 4. How is the satisfaction of the participants with the smart hearing aids? 5. What are the factors leading to the use and non-use of the smart hearing aids? 6. What is the usage time of the smart hearing aids? Auxiliary study questions: 7. How is the caregiver burden when facilitating the participants to use the smart hearing aids? 8. What are the perceived benefits and acceptability of the smart hearing aids?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTechnology
CountriesHong Kong

Timeline

N/ACompletedFinished
202420252026
First PostedMar 17, 2023
Enrollment StartMar 7, 2023
Primary CompletionSep 12, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.3 years ago

Interventions

Experimental group interventiondevice

The caregivers will calibrate the smart hearing aids for the participants in the experimental group at the first day of week 1 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs. Participants in the experimental group can use the smart hearing aids whenever they want during the trial period (i.e. from week 1 to week 6). For participants living in residential setting, caregivers will facilitate them to use the smart hearing aids upon request from the participants or when the caregivers deem the aids beneficial. For participants living in community setting, they will use the smart hearing aids when needed. Their caregivers shall provide assistance in facilitating the participants to use the smart hearing aids. The smart hearing aids do not require any payment from the study participants. They have to return the hearing aids after the study.

Wait-list control group interventiondevice

The caregivers will calibrate the smart hearing aids for the participants in the wait-list control group at week 8 through the designated mobile application. Caregivers will help the participants to choose the amplification level which best suits their needs. Participants in the wait-list control group will continue the current practice (i.e. using conventional hearing aids or no hearing aids) from week 1 to week 8, and will use the smart hearing aids from week 8 to week 14. Caregivers will facilitate the participants to use the smart hearing aids.