UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061155 |
|---|---|
| Receipt number | R000069879 |
| Scientific Title | A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System |
| Date of disclosure of the study information | 2026/04/03 |
| Last modified on | 2026/04/03 18:19:46 |
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Basic information
Public title
A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System
Acronym
OSIA-HOPE Study
Hearing Outcomes and Patient rEported measures
Scientific Title
A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System
Scientific Title:Acronym
A Prospective Observational Study of Audiological Outcomes, Safety, and Cognitive Function in Elderly Patients and Patients with Failed Tympanoplasty Using the Osia System
Region
| Japan |
Condition
Condition
Conductive hearing loss and mixed hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate changes in audiological outcomes and patient-reported outcomes (quality of life) in patients undergoing bone conduction implant surgery using the Cochlea Osia system, and to determine its clinical effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in aided pure-tone average (PTA4 at 0.5, 1, 2, and 4 kHz) at 12 weeks postoperatively compared with baseline
Key secondary outcomes
1.Changes in speech discrimination scores in quiet and noise (SNR +10, +5, 0 dB) at 12, 24, and 48 weeks postoperatively compared with baseline
2.Changes in patient-reported outcomes (SSQ12 and APHAB) at 12, 24, and 48 weeks postoperatively compared with baseline
3.Changes in cognitive function assessed by MoCA at 12, 24, and 48 weeks postoperatively compared with baseline
4.Incidence and severity of postoperative delirium in the acute postoperative period assessed using the Confusion Assessment Method
5.Incidence of postoperative complications (including surgical site infection, skin complications, and magnet-related pressure issues) at 12, 24, and 48 weeks
6.Aided hearing thresholds at 12, 24, and 48 weeks postoperatively
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
Adults aged 20 years or older who are able to understand the study and provide written informed consent
Eligible for bone conduction implantation Osia system defined as:
Presence of conductive or mixed hearing loss in at least one ear
Bone conduction threshold <=55 dB average at 500 1000 2000 and 4000 Hz in the implanted ear
Inability to use or insufficient benefit from air conduction bone conduction or cartilage conduction hearing aids
Meeting at least one of the following:
a. Age >=65 years elderly group
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
Hearing loss primarily due to inner ear pathology
Severe cognitive impairment that precludes completion of questionnaires
Presence of active middle ear infection or cholesteatoma
Cranial anatomy or skin condition unsuitable for Osia system implantation
Bone thickness less than 3 mm
Any other condition deemed inappropriate for study participation by the investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Komori |
Organization
St. Marianna University School of Medicine
Division name
Otolaryngology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
0449778111
manabu.komori@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Komori |
Organization
St. Marianna University School of Medicine
Division name
Otolaryngology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
0449778111
Homepage URL
manabu.komori@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Manabu Komori
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
0449778111
daigakuin@marianna-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NonThis is a single center prospective observational study without additional intervention. Patients undergoing Osia system implantation as part of routine clinical care will be enrolled and clinical data obtained during standard care will be prospectively collected. Evaluations will be performed preoperatively and at 4 12 24 and 48 weeks postoperatively including audiological assessments pure tone audiometry and speech discrimination patient reported outcomes SSQ12 and APHAB cognitive function MoCA postoperative delirium in the acute phase assessed by the Confusion Assessment Method and postoperative complications. Subgroup analyses will be conducted between two groups elderly patients and patients with failed tympanoplasty due to chronic otitis media.
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069879
