Hearing Handicap in Patients With Single Sided Deafness

April 6, 2017 updated by: Rachel Knappett, Cambridge University Hospitals NHS Foundation Trust

Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a significant worsening of hearing in one ear compared to the other.

In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new SSD patients being referred every year.

Only a small number of studies have explored hearing handicap for those with SSD, and music appreciation has not been investigated, to the best of the investigators knowledge, in this patient group.

In the limited number of studies conducted on those with single sided deafness, often only one or two outcome measures have been used, or the patient group has been small. The investigators have a large group of patients with a wide range of aetiologies who have completed several questionnaires as part of their treatment in the single sided deafness clinic and the investigators would like to analyse these data.

At present there are different devices available on the NHS for the management of SSD and many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an under-representation of studies looking specifically at CROS aid devices which is relevant given the cost differences involved between devices.

Study goals and objectives

  • To find out what factors drive hearing handicap in SSD patients by analysing the results of several different well validated hearing handicap questionnaires
  • To find out whether or not it is possible to change hearing handicap in this patient group by looking to see if there is an improvement in questionnaire scores post treatment.
  • The investigators will also look at a sub-group who will be fitted with both traditional wired CROS aids and more up-to-date wireless aids which have been funded through a research grant, in order to assess whether these are more beneficial.
  • The investigators will use a new questionnaire developed in-house to further explore the impact of single sided deafness on music appreciation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SSD can lead to:

  • Reduction in spatial hearing
  • Significant difficulty in background noise and social situations
  • Exhaustion from the extra effort required to hear
  • Reduced confidence
  • Reduced ability to enjoy music
  • Isolation
  • An emotional burden linked to the onset of the hearing loss and associated symptoms

The investigators have established a specialised clinic to address the consequences of SSD, and assess treatment options including the provision of counselling and wired CROS (Contralateral Routing of Signal) hearing aids.

The investigators use a range of questionnaires, completed pre and post treatment, to assess outcomes and would like to analyse this data to see what drives handicap and whether there is any observable improvement post treatment. The investigators would like to find out more about the impact of SSD on patients' ability to enjoy music and propose to do this using a questionnaire developed in-house.

The investigators have been awarded a grant to fit some of their patients with wireless CROS aids, which are not routinely available under the NHS in Cambridge, but are widely available in other areas and in the commercial sector.

The investigators will utilise retrospective data in the form of questionnaires completed by SSD patients attending the Audiology clinic between 2009 and 2012. Prospective data will also be collected and from existing SSD patients, to whom the investigators intend to post the music appreciation questionnaire, or ask them to complete in clinic.

A prospective cross over design study will compare wired and wireless CROS hearing aids in 13 new patients a cross-over design trial to investigate whether residual handicap and satisfaction are any better with these devices than with standard wired versions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB7 5TT
        • Cambridge University Hospital NHS Trust, Audiology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who attend the single sided deafness clinic.
  • Must have either no recordable hearing threshold levels on one side or a significant asymmetry.
  • The 13 CROS aid trial patients must be post-operative vestibular schwannoma patients with an audiological 'dead ear' on the affected side.

Exclusion Criteria:

  • Patients unable to give informed consent
  • Patients under 18 years of age
  • For the CROS aid trial, patients with any aetiology other than vestibular schwanomma, pre-operative vestibular schwanomma patients or vestibular schwanomma patents who still have residual hearing in the affected ear.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Hearing Aid
CROS hearing aid
Device: Hearing Aid
Hearing aid comparison
Other Names:
  • Phonak Nathos S+ Micro Wireless CROS aid
  • Oticon Spirit Zest Wired CROS aid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Abbreviated hearing aid benefit profile (APHAB)
Time Frame: 180 days
Hearing aid benefit questionnaire
180 days
Speech and spatial qualities of hearing (SSQ)
Time Frame: 180 days
Hearing aid benefit questionnaire
180 days
Tinnitus handicap inventory (THI)
Time Frame: 180 days
Tinnitus questionnaire
180 days
Hearing handicap inventory (HHI)
Time Frame: 180 days
Hearing aid benefit questionnaire
180 days
Hospital anxiety and depression scale (HADS)
Time Frame: 180 days
Anxiety and depression questionnaire
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cambridge University Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark D Smith, MSc, Addenbrooke's Hospital, Cambridge, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 108402
  • A092833 (OTHER: Addenbrookes Hospital, Cambridge)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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