- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02294812
Effects of Cognitive Training on Speech Perception
Effects of Cognitive Training on Age-Related Hearing Loss and Speech Perception
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 4R2
- NeuroCognitive Imaging Lab, Dalhousie University
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: 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. |
Experimentální: 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. |
Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Speech Perception in Noise Test - Improvement in speech perception accuracy from baseline to post-training for high and low predictability sentences
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Working Memory Cognitive Training - Improvements in working memory abilities from baseline
Časové okno: 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
Časové okno: 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
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Attention Cognitive Training - Improvements in attention abilities from baseline
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Aaron J Newman, PhD, Dalhousie University, Canada
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NCIL-HL-CT
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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