A Comparative Study of the Effects of Cognitive Functioning with and without Hearing Aid Intervention for People with Hearing Loss

JRCT ID: jRCTs042230166

Registered date:07/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hearing loss
• Date of first enrollment: 07/03/2024
• Target sample size: 324
• Study type: Interventional
• Intervention(s): hearing aid

Outcome(s)

• Primary Outcome: Differences of cognitive function test (MMSE) for twelve months between hearing aid groups and non hearing aid group

Secondary Outcome

- Differences in cognitive function test (MMSE) changes between the two groups (hearing aid and hearing aid non-user) at 6 months
- Differences in cognitive function tests (RBANS) between the two groups (hearing aid use and hearing aid non-use) before use and at 6 and 12 months after the start of the study, respectively
- Difference between the two groups (hearing aid users and hearing aid non-users) in the number of cases of dementia during the study period.
- Differences between the two groups (with and without hearing aids) in the correlations between hearing tests (pure tone and speech tests), cognitive tests, HHIE (hearing loss and quality of life) questionnaire, presence of comorbidities, and LSNS-6 (social interaction scale) at the beginning, 6 months, and 12 months of the study, and between the two groups (with hearing aids and without hearing aids) in the correlations between these tests. hearing aid use and hearing aid non-use) in the correlations.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: < 99age old
• Gender: Both

Include criteria

(1) Patients who have given their written consent.
(2) Patients with chronic sensorineural hearing loss (including mixed hearing loss) whose mean hearing acuity in the four frequencies of 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz is greater than 26 dB and less than 70 dB in pure tone audiometry in both ears.
(3) Word tone audiometry: The best speech intelligibility is greater than 50% in both ears.
(4) Cognitive function test MMSE score of 24 or more.
(5) 65 years old or over and less than 99 years old at the time of consent.
(6) Patients with acquired hearing loss.

Exclude criteria

(1) Patients with conductive hearing loss, or mixed hearing loss, or congenital hearing loss.
(2) Patients with a diagnosis of dementia.
(3) Patients who are unable to undergo cognitive function tests.
(4) Patients who have expressed a desire to use hearing aids prior to enrollment in the study, or patients who refuse to use hearing aids.
(5) Patients who are already using hearing aids.
(6) Patients with cranial nerve disease on MRI.
(7) Patients with psychiatric or other conditions that affect cognitive function, or Patients undergoing treatment or prevention that affects cognitive function.
(8) Other patients deemed by the physician to be excluded due to safety issues or other reasons.

Related Information

• Primary Sponsor: Kanzaki Sho
• Source(s) of Monetary Support: National Hospital Organization