軽度認知障害における不眠症の治療
MCIにおける不眠症に対する神経調節と認知行動療法
The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Peter J Fried, PhD
- 電話番号：617-807-0612
- メール：pfried@bidmc.harvard.edu
研究連絡先のバックアップ
- 名前：Alex Clinical Research Coordinator
- 電話番号：617-667-0386
- メール：adiamon2@bidmc.harvard.edu
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- 募集
- Beth Israel Deaconess Medical Center
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コンタクト：
- Peter J Fried, PhD
- 電話番号：617-807-0612
- メール：pfried@bidmc.harvard.edu
-
コンタクト：
- Alex Clinical Research Coordinator
- 電話番号：617-667-0386
- メール：adiamon2@bidmc.harvard.edu
-
-
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:
- Aged 60 years or older
- Speak and read English
- Clinical diagnosis of MCI or Subjective Cognitive Impairment (SCI)-a perceived gradual worsening in cognitive ability relative to one's younger self, or peer group-reported by either the participant or informant
- Reported insomnia symptoms (sleep-onset and/or sleep maintenance) that cause significant distress or impairment in social, occupational, or other areas of functioning over the past three months
- Have access to an Internet-enabled computer or tablet at home, or ability to connect a BIDMC-provided tablet to the internet, with private space to complete cognitive testing
- Capable of and willing to provide written informed consent
Exclusion Criteria:
- Evidence of significant cognitive impairment or dementia
- Contraindications for TMS or MRI
- Current psychological treatment for insomnia
- Uncontrolled moderate-to-severe obstructive sleep apnea or other untreated sleep disorder (e.g., Restless Leg Syndrome, Periodic Limb Movement Disorder, parasomnia). Sleep apnea that is managed (e.g., regular use of a CPAP) and stable for ≥3 months is allowed.
- Diagnosis of Parkinson's disease, Huntington's disease, Lewy-Body disease, or other neurological condition known to impact sleep
- Current diagnosis of major psychiatric disorder (well-controlled depression or anxiety is permitted)
- Current opiate/opioid use
- Alcohol or drug abuse within the past year
- Irregular sleep schedule (bedtime before 8pm/after 2am OR wake time before 4am/after 10am), unless participant states they are willing and able to change if prompted.
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：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：One (1) TMS treatment per day plus CBT-I
One (1) daily treatment of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program |
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
他の名前：
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
他の名前：
|
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アクティブコンパレータ：Two (2) TMS treatments per day plus CBT-I
Two (2) daily treatments, spaced 1 hour apart, of intermittent theta-burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for 10 days (2 weeks) followed by a 9-week Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) program |
Each treatment consists of 600 TMS pulses (~3 minutes) applied to the L-DLPFC
他の名前：
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
他の名前：
|
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 |
|---|---|---|
|
Insomnia Severity Index
時間枠：Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
|
The Insomnia Severity Index (ISI) is a brief self-assessment tool used to measure the severity of insomnia. It consists of seven questions that evaluate sleep problems, their impact on daily life, and the individual's level of concern about their sleep issues. The total score helps to categorize the severity of insomnia from mild to severe. |
Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
|
|
Paired Associative Learning test (CANTAB)
時間枠：Baseline, Week 3, Week 12, 6 Months
|
The Paired Associative Learning (PAL) test is a computer-based cognitive assessment that evaluates memory and learning. In the test, participants are shown patterns and must remember the locations of these patterns on a screen. It is commonly used to assess spatial memory and detect early signs of memory-related conditions like Alzheimer's disease. |
Baseline, Week 3, Week 12, 6 Months
|
|
Spatial Working Memory test (CANTAB)
時間枠：Baseline, Week 3, Week 12, 6 months
|
The Spatial Working Memory (SWM) test is a computer-based task used to assess the ability to retain and manipulate spatial information. Participants must find hidden tokens within a series of boxes while avoiding revisiting previously searched locations. This test measures executive function and memory, and is often used in research on conditions affecting cognitive function. |
Baseline, Week 3, Week 12, 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Multidimensional Fatigue Symptoms Inventory
時間枠：Baseline, Week 3, Week 12, 6 months
|
The Multidimensional Fatigue Symptom Inventory (MFSI) is a questionnaire designed to assess different aspects of fatigue. It measures five dimensions: general fatigue, emotional fatigue, physical fatigue, mental fatigue, and vigor (energy levels). The tool helps to provide a comprehensive understanding of an individual's fatigue symptoms and their impact on daily functioning. |
Baseline, Week 3, Week 12, 6 months
|
|
Center for Epidemiologic Studies Depression scale
時間枠：Baseline, Week 3, Week 12, 6 months
|
The Center for Epidemiologic Studies Depression scale (CES-D) is a self-report questionnaire designed to measure symptoms of depression in the general population. It consists of 20 questions that assess mood, behavior, and physical symptoms associated with depression over the past week. The CES-D is commonly used in research and clinical settings to screen for depressive symptoms and monitor changes in mood. |
Baseline, Week 3, Week 12, 6 months
|
|
Match to Sample Visual Search test (CANTAB)
時間枠：Baseline, Week 3, Week 12, 6 months
|
The Match to Sample Visual Search (MTS) test is a computerized assessment that measures visual recognition and attention. In the test, participants are shown a sample pattern and must quickly identify the matching pattern from a selection of similar images. It evaluates processing speed, visual memory, and attention to detail, and is often used to study cognitive functions in various neurological and psychiatric conditions. |
Baseline, Week 3, Week 12, 6 months
|
|
Montreal Cognitive Assessment
時間枠：Baseline, Week 3, Week 12, 6 months
|
The Montreal Cognitive Assessment (MoCA) is a quick test used by doctors and other healthcare professionals to check a person's thinking and memory skills. It takes about 10-15 minutes and looks at things like attention, memory, language, and problem-solving. It's often used to help spot early signs of conditions like dementia or mild cognitive impairment. |
Baseline, Week 3, Week 12, 6 months
|
|
Sleep efficiency (sleep diaries)
時間枠：Week 3, Week 13, 6 months
|
Sleep Efficiency is a measure derived from sleep diaries that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings. |
Week 3, Week 13, 6 months
|
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Sleep After Wake Onset (sleep diaries)
時間枠：Week 3, Week 13, Week 40
|
Sleep After Wake Onset (SAWO) is a measure derived from sleep diaries that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions. |
Week 3, Week 13, Week 40
|
|
Sleep Onset Latency (sleep diaries)
時間枠：Week 3, Week 13, Week 40
|
Sleep Onset Latency (SOL) is a measure derived from sleep diaries that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation. |
Week 3, Week 13, Week 40
|
|
Sleep efficiency (actigraphy)
時間枠：Week 3, Week 13, 6 months
|
Sleep Efficiency is a measure derived from actigraphy that indicates the percentage of time spent asleep while in bed, relative to the total time spent in bed. It is calculated by dividing the total sleep time by the total time in bed and multiplying by 100 to get a percentage. A higher sleep efficiency typically suggests more consolidated sleep, while lower sleep efficiency can indicate difficulties with sleep onset or frequent awakenings. |
Week 3, Week 13, 6 months
|
|
Sleep After Wake Onset (actigraphy)
時間枠：Week 3, Week 13, Week 40
|
Sleep After Wake Onset (SAWO) is a measure derived from actigraphy that captures the amount of time a person manages to sleep after experiencing an initial awakening during the night. It represents the total time spent asleep between waking up and the final morning awakening, providing insight into the continuity of sleep and the ability to return to sleep after disruptions. |
Week 3, Week 13, Week 40
|
|
Sleep Onset Latency (actigraphy)
時間枠：Week 3, Week 13, Week 40
|
Sleep Onset Latency (SOL) is a measure derived from actigraphy that indicates the amount of time it takes to fall asleep after going to bed with the intention of sleeping. It is typically recorded in minutes and reflects how easily a person initiates sleep. Longer sleep onset latency may indicate difficulty falling asleep, while shorter latency suggests quicker sleep initiation. |
Week 3, Week 13, Week 40
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cortical Plasticity
時間枠：Baseline (first day of TMS therapy)
|
Cortical plasticity is a measure of the efficacy of long-term potentiation (LTP)-neuroplasticity. It will be measured as the change in the TMS-evoked EEG potential (TEP) following iTBS. |
Baseline (first day of TMS therapy)
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024P000708
- A2024034S (その他の助成金/資金番号：BrightFocus Foundation)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified data will be made available for qualified researchers approximately.
IPD 共有時間枠
Approximately 1 year following the conclusion of the study for at least 5 years
IPD 共有アクセス基準
Researchers at universities and academic medical centers can request de-identified data by sending an email to the PI and describing the nature of the request.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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