Hearing Handicap in Patients With Single Sided Deafness

NCT02525640 | Withdrawn

• 2 other identifiers: 108402A092833
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Keywords

Single sided hearing loss; Single sided deafness; Hearing loss music appreciation

Outcome Measures

Primary Outcomes (5)

• Abbreviated hearing aid benefit profile (APHAB)

  Hearing aid benefit questionnaire

  180 days

• Speech and spatial qualities of hearing (SSQ)

  Hearing aid benefit questionnaire

  180 days

• Tinnitus handicap inventory (THI)

  Tinnitus questionnaire

  180 days

• Hearing handicap inventory (HHI)

  Hearing aid benefit questionnaire

  180 days

• Hospital anxiety and depression scale (HADS)

  Anxiety and depression questionnaire

  180 days

Study Arms (1)

Hearing Aid

EXPERIMENTAL

CROS hearing aid

Device: Hearing Aid

Interventions

Hearing Aid DEVICE

Hearing aid comparison

Also known as: Phonak Nathos S+ Micro Wireless CROS aid, Oticon Spirit Zest Wired CROS aid

Hearing Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge University Hospital NHS Trust, Audiology department

Cambridge, Cambridgeshire, CB7 5TT, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Mark D Smith, MSc

  Addenbrooke's Hospital, Cambridge, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Audiologist

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: August 17, 2015
• Study Start: August 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

GB (1)