NCT02889107

Brief Summary

This study aimed to evaluate long term benefits in speech reception in noise, after daily 10 week use of an assisting listening device (personal frequency-modulates systems) , in non-aphasic stroke patients with auditory processing deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

August 23, 2016

Last Update Submit

August 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)

    Patients are tested in a sound attenuated booth (the crescent of sound) with nine audio stands, an equipment cabinet, and a testing station for the assessment of spatial-listening skills. A 'Speech in noise' test was used. In this test, recorded spoken sentences are presented from straight ahead (0°) while noise is also coming from 90° to the left or right from the participant, who is asked to repeat the sentence. The number of keywords successfully repeated is recorded and repetition of at least three keywords per sentence is required to judge correct performance. The level of the sentences and the background noise are adaptively varied to estimate the signal-to-noise ratio (SNR) for 50% correct performance. The test was conducted with the participant using the frequency modulated systems (aided condition) or not using the frequency modulated systems (unaided condition). The level of SNR is reported in dB.

    week 1

Secondary Outcomes (1)

  • The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)

    week 10

Study Arms (2)

standard care

NO INTERVENTION

Patients received standard listening strategies for 10 weeks

intervention

EXPERIMENTAL

Patients received an assistive listening device (personal frequency modulated systems) for 10 weeks

Other: personal frequency modulated systems

Interventions

patients used personal frequency modulated systems for at least 4 hours daily for 10 weeks

Also known as: FM systems
intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical history of ischaemic stroke verified by brain magnetic resonance imaging (MRI)
  • Diagnosis of auditory processing disorders
  • Normal pure-tone audiogram

You may not qualify if:

  • Severe aphasia
  • Significant psychiatric illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospitals

London, United Kingdom

Location

Related Publications (1)

  • Koohi N, Vickers D, Warren J, Werring D, Bamiou DE. Long-term use benefits of personal frequency-modulated systems for speech in noise perception in patients with stroke with auditory processing deficits: a non-randomised controlled trial study. BMJ Open. 2017 Apr 7;7(4):e013003. doi: 10.1136/bmjopen-2016-013003.

MeSH Terms

Conditions

Language Development DisordersStroke

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Doris-Eva Bamiou, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader & Consultant in Audiovestibular Medicine

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 5, 2016

Study Start

April 1, 2013

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations