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At-home Auditory Training Clinical Trial (Training)

3. juli 2019 oppdatert av: Larry Humes, Indiana University
The purpose of this study is to investigate the effectiveness of an auditory training program used at home with the subject's own hearing aids.

Studieoversikt

Detaljert beskrivelse

The most common communication complaint of older adults with impaired hearing is that they can hear speech, but can't understand it. This is especially true where there are competing sounds in the background. Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids. All testing for the screening, baseline speech testing, training system orientation, and the outcomes portions of this project will be conducted in the Audiology Research Laboratory (ARL) of the Speech and Hearing Center located at 200 South Jordan Avenue. The use of the training program will be done at the subject's home.

Subjects will first come to the ARL for either one session for a hearing aid follow-up and instruction in the use of the training system (Session 1) or for one session for an initial screening to determine eligibility (Screening) followed then by Session 1. Subjects will then take home a training system that includes a tablet computer that has the training program loaded onto it, a portable loudspeaker, and some accessories. There will be three groups of subjects: (1) Hearing aid alone--no training (passive control); (2) Hearing aid plus auditory training (training); and (3) Hearing aid plus audio book use (active control). Total enrollment will be 45 subjects. Those subjects in the training group and active control group will complete a 6-week training period and return to the lab for outcome measures after 6 weeks of training for the primary and secondary outcome measures. The hearing aid alone group will return for the same outcome measures as the training and active control groups, but will have no intervention between these follow-up sessions.

Studietype

Intervensjonell

Registrering (Faktiske)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Indiana
      • Bloomington, Indiana, Forente stater, 47405-7002
        • IU Department of Speech & Hearing Sciences

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

55 år til 79 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • •55-79 yrs of age

    • Native English speaker

      • Having corrected vision sufficient to read 18pt font on a computer screen
      • Wearing binaural hearing aids that were fitted within the past 3 years that are the only hearing aids the subject has ever worn

Exclusion Criteria:

  • The hearing aids worn by the subject will be evaluated on the subject's ears and must be functioning as required for this study; otherwise, the subject will be excluded from participation until the hearing aids have been adjusted appropriately
  • asymmetrical hearing loss
  • presence of dementia, Parkinson's disease, or other neurological disorder

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Passive Control
Hearing aid alone
Eksperimentell: Training
Auditory Training Program. Hearing aid plus auditory training
Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.
Sham-komparator: Active control
Sham comparator: Active control. Hearing aid plus audio-book use
This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Connected Speech Test (CST) Score
Tidsramme: Baseline (prior to training) and 6-weeks later (after training)
The CST is an "objective" measure of speech-understanding in noise that will be obtained when the patient's are wearing their hearing aids. The patient hears standardized recordings of the speech in noise and then reports the sentences that were heard. These are scored as percent correct. Baseline AIDED CST score was obtained prior to the intervention period and immediately following 6-week intervention. The results reflect the CHANGE in CST from pre- to post-intervention with positive numbers indicating improved speech understanding in noise following training.
Baseline (prior to training) and 6-weeks later (after training)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Aided Profile of Hearing Aid Performance (PHAP) Score
Tidsramme: Baseline (pre-training) and 6 weeks later (post training)
Change in aided performance on the Profile of Hearing Aid Performance (PHAP), a self-report measure of the frequency of listening difficulties experienced by the individual. The aided PHAP scores are proportions of time difficulties encountered in various listening situations while wearing hearing aids. Low PHAP scores indicate less frequent difficulties and reflect better aided performance. The range of possible PHAP scores are 0.0 to 1.0.There are seven subscales of the PHAP and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHAP global. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). Scores reported below are the CHANGE in aided PHAP global scores, baseline minus post-training.
Baseline (pre-training) and 6 weeks later (post training)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Larry E Humes, PhD, Indiana University Department of Speech and Hearing Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2013

Primær fullføring (Faktiske)

1. februar 2015

Studiet fullført (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først innsendt

2. august 2013

Først innsendt som oppfylte QC-kriteriene

20. september 2013

Først lagt ut (Anslag)

25. september 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2019

Sist bekreftet

1. juli 2019

Mer informasjon

Begreper knyttet til denne studien

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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