NCT06047639

Brief Summary

The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in chronic otitis media patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

3.5 years

First QC Date

September 14, 2023

Last Update Submit

May 1, 2024

Conditions

Hearing

Outcome Measures

Primary Outcomes (3)

  • free field hearing level

    Measuring hearing threshold with device on

    one year

  • Speech, Spatial and Qualities of Hearing Scale

    Subjective evaluation of the hearing by questionaries

    One year

  • World Health Organisation(WHO) Quality of Life Questionarie

    Standard question list about the general health and quality of life of the patient

    One year

Secondary Outcomes (1)

  • Cost Benefit of the intervention

    on year

Study Arms (1)

Bone Anchored Hearing Implants(BAHI) Patient

Patients with chronic otitis media whose hearing could not corrected with surgery and also could not use conventional and got bone-anchored hearing implants as a standard of care were included.

Device: Bone-anchored hearing implants

Interventions

Bone-anchored hearing implantsDEVICE

surgically placed hearing device

Bone Anchored Hearing Implants(BAHI) Patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic otitis media whose hearing could not corrected with surgery and also could not use conventional and got bone-anchored hearing implants as a standard of care

You may qualify if:

  • Adults
  • No difficulty in coming to the hospital for follow-up
  • Ability to communicate and express oneself at a level sufficient to interact with researchers
  • Having an indication for BAHI due to Chronic Otitis media

You may not qualify if:

  • Those with severe systemic illnesses (cancer, HIV, etc.)
  • Psychiatric patients experiencing compliance issues with hearing tests
  • Use of medication or medical devices that could affect the outcome of the study
  • Patients who cannot adhere to regular follow-ups and do not use the device will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

Study Officials

  • Fazıl N Ardıç, MD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of Otolaryngology

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

August 8, 2020

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Locations

TU(1)