- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02294812
Effects of Cognitive Training on Speech Perception
Effects of Cognitive Training on Age-Related Hearing Loss and Speech Perception
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 4R2
- NeuroCognitive Imaging Lab, Dalhousie University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Able to come to Dalhousie University, Halifax, Nova Scotia, Canada for study visits
- Adults (50 years or older) with mild to moderate hearing loss
- Access to an internet-connected device that is able to use Flash media, basic computer skills
- Medically stable participants
- Not currently taking medication that may affect brain function (e.g., anti-anxiety medication)
- Normal or corrected-to-normal vision
Exclusion Criteria:
- Participants with neurological conditions such as epilepsy or concussions will be excluded for safety reasons
- Participants who are not native English speakers (materials used in the study are only in English)
- Participants who are unable to provide consent
- Participants with impaired cognition (assessed with the Montreal Cognitive Assessment)
- Participants with high accuracy on the Speech Perception in Noise task at the second study visit (to eliminate participants who may be performing at ceiling level)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Control, cognitive training
Participants in the control arm will receive cognitive training for cognitive abilities not affected by age-related hearing loss.
|
Participants will engage in eight weeks of training that focuses on improving various cognitive abilities. For example, short term memory. Cognitive training will take place 30 minutes per day, five days per week, for eight weeks. Training will be done in the participant's own home using web-based software. Participants will be randomly assigned to either the active control group, the control cognitive training group, or the experimental cognitive training group following the second study visit. After eight weeks, participants will no longer partake in training. |
|
Experimental: Experimental, cognitive training
Participants in the experimental arm will receive cognitive training for cognitive abilities affected by age-related hearing loss.
|
Participants will engage in eight weeks of training that focuses on improving various cognitive abilities. For example, short term memory. Cognitive training will take place 30 minutes per day, five days per week, for eight weeks. Training will be done in the participant's own home using web-based software. Participants will be randomly assigned to either the active control group, the control cognitive training group, or the experimental cognitive training group following the second study visit. After eight weeks, participants will no longer partake in training. |
|
Aktiver Komparator: Active Control, crossword training
Participants in this group will undergo crossword puzzle training.
The purpose of this group is control for any effects that may be due to engaging in cognitive training.
|
Participants will engage in eight weeks of training that focuses on improving various cognitive abilities. For example, short term memory. Cognitive training will take place 30 minutes per day, five days per week, for eight weeks. Training will be done in the participant's own home using web-based software. Participants will be randomly assigned to either the active control group, the control cognitive training group, or the experimental cognitive training group following the second study visit. After eight weeks, participants will no longer partake in training. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Speech Perception in Noise Test - Improvement in speech perception accuracy from baseline to post-training for high and low predictability sentences
Zeitfenster: Baseline, Weeks 2, 10, and 18
|
Sentences of high predictability and low predictability are played with multi-user talker babble.
Participants must repeat the last word of each sentence as they heard it.
The primary outcome measure will be the accuracy for repeating the sentence.
|
Baseline, Weeks 2, 10, and 18
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Working Memory Cognitive Training - Improvements in working memory abilities from baseline
Zeitfenster: Weeks 2, 10, and 18
|
Individuals are asked to participate in 20 hours of cognitive training that will focus on either improving abilities affected by hearing loss (i.e., verbal working memory), or abilities not affected by hearing loss (i.e., spatial working memory). Performance on the working memory task, Operation Span Task (OSPAN), will be assessed using the total score which is calculated as a sum based on the number of correct answers (letters accurately sequentially recalled) within a block for the duration of the task. Higher scores indicate better working memory capacity. Performance on the working memory cognitive training games will be assessed using the participant's accuracy, reaction time, and final score on the game. Improvements in working memory will be assessed by comparing participant performance on working memory tasks (OSPAN; cognitive training memory games) before receiving cognitive training, immediately after receiving cognitive training, and eight weeks post-training. |
Weeks 2, 10, and 18
|
|
Brain Performance Test
Zeitfenster: Weeks 2 and 10
|
The Brain Performance Test (BPT) is an assessment tool available online through the training program website.
Participants will be assessed at home on their initial performance for a variety of cognitive abilities including stop-signal tasks, grammatical reasoning, and memory spans.
After completing the eight weeks of cognitive training, participants will again be assessed at home with the BPT to determine whether there are any improvements in cognitive abilities.
|
Weeks 2 and 10
|
|
Attention Cognitive Training - Improvements in attention abilities from baseline
Zeitfenster: Weeks 2, 10, and 18
|
Individuals are asked to participate in 20 hours of cognitive training. Cognitive training will focus on either improving abilities affected by hearing loss (i.e., attention), or abilities not affected by hearing loss (i.e., spatial working memory). Performance on the attention task, Flanker-Simon, will be assessed based on participant's accuracy and reaction time for the Flanker task, and the Simon task. Performance on the attention cognitive training games will be assessed using the participant's accuracy, reaction time, and final score on the game. Improvements in attention will be assessed by comparing the performance of participants on attention tasks (Flanker-Simon; cognitive training attention games) before receiving cognitive training, immediately after receiving cognitive training, and eight weeks post-training. |
Weeks 2, 10, and 18
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Aaron J Newman, PhD, Dalhousie University, Canada
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- NCIL-HL-CT
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .