治疗轻度认知障碍的失眠
神经调节和认知行为疗法治疗 MCI 失眠
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Peter J Fried, PhD
- 电话号码:617-807-0612
- 邮箱:pfried@bidmc.harvard.edu
研究联系人备份
- 姓名:Alex Clinical Research Coordinator
- 电话号码:617-667-0386
- 邮箱:adiamon2@bidmc.harvard.edu
学习地点
-
-
Massachusetts
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Boston、Massachusetts、美国、02215
- 招聘中
- Beth Israel Deaconess Medical Center
-
接触:
- Peter J Fried, PhD
- 电话号码:617-807-0612
- 邮箱:pfried@bidmc.harvard.edu
-
接触:
- Alex Clinical Research Coordinator
- 电话号码:617-667-0386
- 邮箱:adiamon2@bidmc.harvard.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器: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
其他名称:
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
其他名称:
|
|
有源比较器: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
其他名称:
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insomnia Severity Index
大体时间: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)
大体时间: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)
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Multidimensional Fatigue Symptoms Inventory
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
|
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Sleep efficiency (sleep diaries)
大体时间: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
|
|
Sleep After Wake Onset (sleep diaries)
大体时间: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
|
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Sleep Onset Latency (sleep diaries)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cortical Plasticity
大体时间: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)
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2024P000708
- A2024034S (其他赠款/资助编号:BrightFocus Foundation)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
De-identified data will be made available for qualified researchers approximately.
IPD 共享时间框架
Approximately 1 year following the conclusion of the study for at least 5 years
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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