경도 인지 장애의 불면증 치료
MCI의 불면증에 대한 신경조절 및 인지행동치료
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Peter J Fried, PhD
- 전화번호: 617-807-0612
- 이메일: pfried@bidmc.harvard.edu
연구 연락처 백업
- 이름: Alex Clinical Research Coordinator
- 전화번호: 617-667-0386
- 이메일: adiamon2@bidmc.harvard.edu
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- 모병
- Beth Israel Deaconess Medical Center
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연락하다:
- Peter J Fried, PhD
- 전화번호: 617-807-0612
- 이메일: pfried@bidmc.harvard.edu
-
연락하다:
- Alex Clinical Research Coordinator
- 전화번호: 617-667-0386
- 이메일: adiamon2@bidmc.harvard.edu
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: 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
다른 이름들:
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
다른 이름들:
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활성 비교기: 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
다른 이름들:
9-week fully-automated, Internet-delivered CBT-I program: SHUTi OASIS (Sleep Healthy Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insomnia Severity Index
기간: Baseline, Week 3 (Post-TMS), Week 12 (Post-CBT-I), 6 months (follow-up)
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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)
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Paired Associative Learning test (CANTAB)
기간: Baseline, Week 3, Week 12, 6 Months
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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
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Spatial Working Memory test (CANTAB)
기간: Baseline, Week 3, Week 12, 6 months
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Multidimensional Fatigue Symptoms Inventory
기간: Baseline, Week 3, Week 12, 6 months
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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
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Center for Epidemiologic Studies Depression scale
기간: Baseline, Week 3, Week 12, 6 months
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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
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Match to Sample Visual Search test (CANTAB)
기간: Baseline, Week 3, Week 12, 6 months
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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
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Montreal Cognitive Assessment
기간: Baseline, Week 3, Week 12, 6 months
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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)
기간: Week 3, Week 13, 6 months
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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)
기간: Week 3, Week 13, Week 40
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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)
기간: Week 3, Week 13, Week 40
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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
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Sleep efficiency (actigraphy)
기간: Week 3, Week 13, 6 months
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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
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Sleep After Wake Onset (actigraphy)
기간: 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
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Sleep Onset Latency (actigraphy)
기간: Week 3, Week 13, Week 40
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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
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cortical Plasticity
기간: Baseline (first day of TMS therapy)
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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)
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공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2024P000708
- A2024034S (기타 보조금/기금 번호: BrightFocus Foundation)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified data will be made available for qualified researchers approximately.
IPD 공유 기간
Approximately 1 year following the conclusion of the study for at least 5 years
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .