Aural Rehab for Adult CI Outcomes
A Phase I, Single-Center Study of the Effects of Aural Rehabilitation Protocols on Adult Cochlear Implant Outcomes
This study will compare two different types of aural rehabilitation schedules (computer-based auditory training vs computer based auditory training and clinician guided training) for adult cochlear implant (CI) users to determine the effect of rehabilitation type on speech perception, hearing related-quality of life, and CI management skills.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: J. Thomas Roland, Jr., MD
- Telefonnummer: 212-263-5565
- E-Mail: J.Thomas.RolandJr@nyulangone.org
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10016
- NYU Langone Heath
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Be at least 18 years of age at the time of cochlear implantation.
- Receive pre- and post-CI care at the NYU Langone Health Cochlear Implant Center.
- Have bilateral hearing loss, with at least moderate to profound hearing loss in both ears.
- Be able to participate in follow-up visits, either in person or via synchronous telehealth, and to use an app-based training platform (ReDi).
- Be English-speaking or have native-like English proficiency.
Exclusion Criteria:
- Has significant cognitive impairment or a medical disability that precludes informed consent or reliable participation or develops such impairment during the study period.
- Has pre-lingual or long-term (>20 years) severe to profound hearing loss
- Is undergoing cochlear implantation for single-sided deafness.
- Is undergoing revision CI surgery.
- Is younger than 18 years of age.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Computer-Based Auditory Training
CI users assigned to receive computer-based auditory training only. |
Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation. |
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Experimental: Computer-Based Auditory Training + Clinician-Guided Training
CI users assigned to receive computer-based auditory training and clinician-guided training. |
Aural rehabilitation program delivered through an auditory training app. Each participant will be assigned to complete training 5 days per week, with each session being 15 minutes for the first 6 months post-activation. Aural rehabilitation program delivered by a speech-language pathologist. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in CNC Word Recognition Score
Zeitfenster: Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Calculated as the percentage of words a person can hear, repeat back, and understand. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
|
Change in CNC Phoneme Recognition Score
Zeitfenster: Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Calculated as the percentage of individual phonemes (sounds) identified correctly out of 150 total phonemes. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
|
Change in AzBio Sentence Recognition Score
Zeitfenster: Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Standardized speech perception assessment used by audiologists to measure how well a person understands everyday conversational speech. Patients are evaluated on their ability to recognize words correctly in a sentence. Each sentence has a set number of key words assigned specific point values. The final score is calculated as a percentage of words correct out of the total possible words in the list. |
Baseline (pre-cochlear implant), Year 1 Post-Activation
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in CIQOL35 Profile Score
Zeitfenster: Week 6 Post-Activation, Year 1 Post-Activation
|
Patient-reported outcome measure designed to evaluate real-world functional abilities and quality of life for adult cochlear implant (CI) users. Each item is rated on a Likert scale; the raw score is re-scaled into a total score from 0 (low quality of life/functional ability) to 100 (high quality of life/functional ability). |
Week 6 Post-Activation, Year 1 Post-Activation
|
|
Change in CIMS-Self
Zeitfenster: Week 6 Post-Activation, Year 1 Post-Activation
|
10-item self-administered assessment of how effectively a patient or caregiver handles and maintains a cochlear implant processor. Each response is rated from 0 to 3; the raw score is the sum of responses and is transformed to a percentage (0 - 100%); a score below 100% indicates a need for targeted training or retraining in specific maintenance areas. |
Week 6 Post-Activation, Year 1 Post-Activation
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: J. Thomas Roland, Jr., MD, NYU Langone Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 26-00880
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
No plan to make IPD available.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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