Evaluating Short-term Effects of Computerized Brain Fitness Exercises in Adult Cochlear Implant and/or Hearing Aid Users
Evaluating Short-term Effects of Home-based Computerized Multi-domain Cognitive Training in Adult Cochlear Implant and/or Hearing Aid Users: A Prospective Randomized Intervention Study
調査の概要
詳細な説明
Aural rehabilitation is a life long process in spite of advanced innovative implant technology. Existing standard therapy is inadequate for some people, because even after years of surgery many implant users does not obtain significant benefits, like improved understanding of spoken sentences. In many cases it seems that the speech comprehension deficits are linked to particular cognitive functions in cochlear implant users, including memory and attention. In this study we will test whether a computer-based set of "cognitive fitness" or "brain training" games designed to improve memory and attention will help cochlear implant and hearing aid users to understand speech better.
Cochlear implant and hearing aid users will complete 10 weeks of computer-based cognitive training on their home computers. Half of participants will do this training immediately after being enrolled in the study; the other half will receive the training beginning 10 weeks after they are enrolled. Speech comprehension and cognitive abilities will be assessed at baseline, 10, 20 and 30 weeks in all participants.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H 4R2
- NeuroCognitive Imaging Lab, Dalhousie University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adult cochlear implant users, and/or people with moderate/severe hearing loss using bilateral hearing aids, aged 19 or above
- Access to an internet-connect device that supports flash, and basic computer skills
- Medically stable patients
Exclusion Criteria:
- Patients with epilepsy, severe visual and cognitive difficulties, chronic fatigue syndrome, and serious co-morbid conditions which could be exacerbated by the computer training games will be excluded for safety reasons.
- Patients who are unlikely to adhere to the intervention due to dementia, Parkinson's disease, Parkinson-plus syndrome, movement disorders or disability that would impair the person's ability to perform the training (e.g., problems with attention, alertness, or learning disorders)
- Participants who cannot speak English (since study materials are only in English), or unable to give consent.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Immediate cognitive fitness training
After the initial baseline evaluation, the immediate treatment group participants will receive individualized multi-domain cognitive training and standard of care.
Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval.
After 10 weeks of cognitive fitness training, participants in this group will switch to a 20 week "no intervention" period where they receive only standard of care treatment.
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Computer-based training of basic cognitive functions. It has activities under two headings,
Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval. |
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他の：Delayed cognitive fitness training
After the initial baseline evaluation, the delayed cognitive fitness training group participants will receive only standard of care for 10 weeks ("no intervention" period).
Starting in week 11, participants in this arm will receive individualized multi-domain cognitive training and standard of care.
Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval.
After 10 weeks of cognitive fitness training, participants will go for another 10 weeks with only standard of care treatment.
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Computer-based training of basic cognitive functions. It has activities under two headings,
Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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AzBio Sentence test - change in score from baseline to post-training
時間枠：Baseline, Weeks 10, 20 and 30
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Sentences are played along with masking noise (multi-talker babble).
Participants must repeat each sentence as they heard it.
Accuracy in repeating the sentences is the outcome measure.
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Baseline, Weeks 10, 20 and 30
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in CANTABeclipse for clinical trials
時間枠：Baseline, Weeks 10, 20 and 30
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It is a method of assessing the brain-functions of a person using computerized non-linguistic tests by touch screen technology making it rapid and safe.
It has been widely used globally to assess brain-functions in more than 100 disorders.
More than 700 articles have been published using CANTABeclipse by over 500 academic institutions or industry researchers in 60 different countries.
Tasks are performed by touch screen technology.
It assesses brain-functions such as planning, problem solving, working memory etc.
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Baseline, Weeks 10, 20 and 30
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Change from Baseline in Speech Spatial Qualities questionnaire
時間枠：Baseline, Weeks 10, 20 and 30
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The Spatial Speech Qualities of Hearing scale questionnaire (SSQ; Gatehouse & Noble, 2004) is used to assess the self reported hearing disabilities across several domains such as hearing speech in challenging contexts and to the directional, distance and movement components of spatial hearing.
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Baseline, Weeks 10, 20 and 30
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Change from Baseline in CogniFit NeuroPsychological Assessment
時間枠：Baseline, Weeks 10, 20 and 30
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The CogniFit Neuropsychological assessment is a multi domain cognitive task.
It measures 18 cognitive abilities such as visuospatial working memory, visuospatial learning, focused attention, updating, monitoring etc. (Haimov et al., 2008; Peretz et al., 2011b; Shatil et al., 2010; Verghese et al., 2010)
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Baseline, Weeks 10, 20 and 30
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Adherence record
時間枠：Upto 30 weeks
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Access usage data from CogniFit website will be recorded.
Recording includes time spent on each session (start and end time), number of games played during each session
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Upto 30 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Aaron Newman, PhD、Dalhousie University, Canada
- 主任研究者：Christoph Gradmann、University of Oslo
出版物と役立つリンク
便利なリンク
- NeuroCognitive Imaging Lab (NCIL) is a service of Department of Psychology at Dalhousie University, Canada. Participants visit the NCIL to complete a cognitive and hearing assessment. However, they perform the training tasks from their own homes.
- The Department of Community Medicine is primary affiliation of the Sub-Investigator, Dr. Amit Bansal. He is pursuing M.Phil International Community Health at the University of Oslo, Norway under supervision of Drs. Gradmann, Lian and Newman.
- The clinical trial is conducted at the Department of Psychology, Dalhousie University, Canada
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Cognitive fitness trainingの臨床試験
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University of MinnesotaNational Institute of Mental Health (NIMH)募集精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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University of Alabama at BirminghamUnited States Department of Defense完了
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Douglas Mental Health University Institute募集
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了
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Centre Hospitalier Universitaire de Saint Etienne完了