UMIN-CTR Clinical Trial

Basic information
Public title	The effect of hearing aids on posturography in the elderly
Acronym	Hearing aids and posturography in the elderly
Scientific Title	The effect of hearing aids on posturography in the elderly
Scientific Title:Acronym	Hearing aids and posturography in the elderly
Region	Japan

Condition
Condition	sensorineural hearing loss
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To see the effect of hearing aids on the posturography in the elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	total length, area, velocity, center of foot pressure
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	sensorineural heairng loss
Interventions/Control_2	normal hearing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Those with bilateral sensorineural hearing loss attendind Iwate Medical Univeristy Those older than 60, without other neuromuscular diseases Those who are wearing a hearing aid more than 1 year
Key exclusion criteria	Those who cannot stand still during the examination
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Harukazu Middle name Last name Hiraumi
Organization	Iwate Medical University
Division name	Otolaryngology
Zip code	028-3695
Address	2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL	019-613-7111
Email	hhiraumi@iwate-med.ac.jp

Public contact
Name of contact person	1st name Harukazu Middle name Last name Hiraumi
Organization	Iwate Medical University
Division name	Otolaryngology
Zip code	028-3695
Address	2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL	019-613-7111
Homepage URL
Email	hhiraumi@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	JSPS
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Iwate Medical University
Address	2-1-1, Idai doori, Yahaba City, Shiwa, Iwate
Tel	019-613-7111
Email	hhiraumi@iwate-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	岩手医科大学、岩手県立大学

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 07 Day

Related information
URL releasing protocol	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258590
Publication of results	Published

Result
URL related to results and publications	https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258590
Number of participants that the trial has enrolled	20
Results	The interaction among eye condition, sound condition, and between-group factor was significant in the maximum displacement of the center-of-pressure in the mediolateral axis. The maximum displacement of the center-of-pressure in the mediolateral axis improved with the auditory cues in the normal-hearing participants in the eyes closed condition. In the hearing aid users, this difference was not significant.
Results date posted	2022 Year 06 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We recorded the findings of 10 experienced hearing aid users and 10 normal-hearing participants
Participant flow	Recruited at Iwate Medical University
Adverse events	No
Outcome measures	The posturographic measurements were conducted under eight conditions: (1) eyes open on a foam pad, with and without HA, (2) eyes closed on a foam pad, with and without HA, (3) eyes open on a rigid surface, with and without HA, and (4) eyes closed on a rigid surface, with and without HA.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 01 Month 07 Day
Date of IRB	2020 Year 03 Month 23 Day
Anticipated trial start date	2020 Year 03 Month 23 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry	2021 Year 02 Month 28 Day
Date trial data considered complete	2021 Year 02 Month 28 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 12 Month 04 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044228