Trial record 1 of 1 for:    NCT01858246
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A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Ninewells Hospital
Sponsor:
Information provided by (Responsible Party):
Stephen Jones, Ninewells Hospital
ClinicalTrials.gov Identifier:
NCT01858246
First received: May 15, 2013
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.


Condition Intervention
Hearing Loss, Conductive
Bone Conduction Deafness
Device: Bonebridge
Device: Bone Anchored Hearing Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

Resource links provided by NLM:


Further study details as provided by Ninewells Hospital:

Primary Outcome Measures:
  • Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists [ Time Frame: Up to 1 year post-operatively ] [ Designated as safety issue: No ]
    We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices


Secondary Outcome Measures:
  • Speech audiogram result at 60 dB A in noise using AB word lists [ Time Frame: Up to 1 year after implantation ] [ Designated as safety issue: No ]
    The speech audiogram will also be carried out in noise to demonstrate whether one device gives an appreciable advantage over another with respect to understanding in noise compared to silence.

  • Patient reported outcome data [ Time Frame: Up to 1 year following implantation ] [ Designated as safety issue: No ]
    Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires

  • Time from surgery to device switch-on [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    The time (measured in days) will be recorded from the date of implantation to the date of its switch-on.

  • Number of patient episodes required during study period [ Time Frame: 1 year from implantation ] [ Designated as safety issue: No ]
  • Time to complete wound healing [ Time Frame: Up to 3 months from implantation ] [ Designated as safety issue: No ]
    Measured in days, as judged subjectively by ENT medical and nursing staff


Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bonebridge
Implantation with a Bonebridge
Device: Bonebridge
Active Comparator: Bone Anchored Hearing Aid
Implantation with a Bone Anchored Hearing Aid
Device: Bone Anchored Hearing Aid

Detailed Description:

The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids.

There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge.

The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Conductive Hearing Loss within criteria for Bonebridge
  • Adults

Exclusion Criteria:

  • Children
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858246

Locations
United Kingdom
Ninewells Hospital and Medical School Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Stephen EM Jones, MBBS, FRCS    +44 (0) 1382 660111 ext 32162    stephenemjones@nhs.net   
Principal Investigator: Stephen EM Jones, MBBS, FRCS         
Sub-Investigator: Patrick M Spielmann         
Sub-Investigator: Musheer Hussain         
Sub-Investigator: Samantha Batty         
Sponsors and Collaborators
Ninewells Hospital
Investigators
Principal Investigator: Stephen EM Jones NHS Tayside
  More Information

No publications provided

Responsible Party: Stephen Jones, Consultant ENT Surgeon, Ninewells Hospital
ClinicalTrials.gov Identifier: NCT01858246     History of Changes
Other Study ID Numbers: SJPSMH01
Study First Received: May 15, 2013
Last Updated: May 4, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Ninewells Hospital:
Hearing Loss, Conductive
Bone Conduction
bone conduction thresholds better than 45 dBHL

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Conductive
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014