- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03840083
Sleep-dependent Learning in Aging
What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging
연구 개요
상세 설명
Exp 1: Using neuroimaging, the investigators will consider whether differences in brain areas engaged during memory encoding contribute to age-related changes in sleep-dependent memory consolidation for a word-pair learning task.
Exp 2: The investigators will examine the rate of memory decay between encoding and sleep using two probes of declarative memory (word-pair learning and visuo-spatial learning).
Exp 3: The investigators will provide additional opportunity for encoding of the word-pair and visuo-spatial learning tasks.
Exp 4: Using neuroimaging, the investigators will examine neural engagement during encoding and performance following intervals of sleep and wake.
Exp 5: The investigators will examine the rate of decay of motor sequence learning.
Exp 6: The investigators will examine whether enhanced training ('overtraining') improves sleep-dependent memory consolidation for older adults.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Amherst, Massachusetts, 미국, 01003
- 모병
- University of Massachusetts
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연락하다:
- Mary Emma Searles
- 전화번호: 413-545-4831
- 이메일: msearles@umass.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18-75 yrs
- Healthy sleeper
- No diagnosed sleep or neurodegenerative disorder
Exclusion Criteria:
- Past diagnosis of any sleep disorder or evidence of a sleep disorder as assessed by self-reported sleep quality assessments, a standardized diagnostic interview, and an acclimation night of polysomnography. Using acclimation-night polysomnography, participants will be excluded with an Apnea-Hypopnea Index >15; a Period-Limb Movement in Sleep index of >15/hr; sleep-onset latency > 45 min (indicative of insomnia); or sleep efficiency < 80% (see Edinger et al., Sleep, 2004). In cases in which questions arise regarding a participants' inclusion or sleep records, a practicing neurologist board-certified in sleep medicine will review the documentation.
- Past diagnosis neurological illness or head injury
- Reported average sleep per night < 5 or > 9 hrs
- Current employment involving shift work or an inability to keep a regular sleep schedule during the week prior to testing
- Current use of psychotropic, recreational drugs, or sleep-altering medications (sleep medications, cold medicines within the past week, clonidine, sympathomimetic stimulants)
- Daily caffeine intake of > 4 cups (coffee, tea, colas)
- Weekly alcohol intake of > 10 cups
- Pregnancy or < 12 months post-partum
- History of bipolar disorder, mania, or current evidence of depression as measured by Beck Depression Inventory score > 25
- Abnormal sleep (e.g., shift work, travel across >2 time zones within the past 3 months).
- Diagnosis of any Axis I disorder, neurological illness or head injury (according to Demographic and Health History form);
- Score indicative of cognitive dysfunction (subtest scores < 40)
- Beck Depression Scale score indicative of depression (> 19).
Additionally, individuals will be excluded from magnetic resonance imaging studies (Exps 1, 4) for:
- Left handed or ambidextrous
- Claustrophobia
- Presence of metal (thoroughly screened via questionnaire and metal detector)
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Sleep
Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6)
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Participants will sleep (either a mid-day nap or normal overnight sleep)
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간섭 없음: Wake
Individuals will stay awake for the same amount of time as they slept in the sleep condition
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in memory accuracy for intervention compared to control
기간: 2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)
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We will measure memory accuracy before the sleep/wake interval and subtract this from memory accuracy after the sleep wake interval.
If sleep benefits memory then this value will be greater in the sleep condition compared to the wake condition.
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2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2017-4290
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Sleep에 대한 임상 시험
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Leiden UniversityBioClock Consortium; Caring Univeristies완전한
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Brain Electrophysiology Laboratory Company완전한
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Kanuni Sultan Suleyman Training and Research Hospital완전한
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University of Maryland, Baltimore종료됨