- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840083
Sleep-dependent Learning in Aging
What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging
Study Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Amherst, Massachusetts, United States, 01003
- Recruiting
- University of Massachusetts
-
Contact:
- Mary Emma Searles
- Phone Number: 413-545-4831
- Email: msearles@umass.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep
Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6)
|
Participants will sleep (either a mid-day nap or normal overnight sleep)
|
No Intervention: Wake
Individuals will stay awake for the same amount of time as they slept in the sleep condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in memory accuracy for intervention compared to control
Time Frame: 2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)
|
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.
|
2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-4290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionEnrolling by invitation
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Baylor College of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruiting
-
Brain Electrophysiology Laboratory CompanyCompletedSleep | Sleep HygieneUnited States
-
Koko Home, Inc.Stanford UniversityRecruitingSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Sleep HygieneUnited States
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, Wisconsin; Divine Savior...Active, not recruitingSleep | Sleep HygieneUnited States
-
Aretaieion University HospitalRecruitingSleep Disorder | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Surgery | Anesthesia | Sleep Fragmentation | Sleep Disorders, Circadian RhythmGreece
-
ResMedCRI-The Clinical Research Institute GmbH; University Hospital RegensburgCompletedObstructive Sleep Apnea | Central Sleep Apnea | Mixed Sleep Apnea | Complex Sleep ApneaSwitzerland, Spain, Denmark, Portugal, France, Germany
Clinical Trials on Sleep
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)RecruitingSleep | Obesity, Childhood | Binge Eating | Self-regulationUnited States
-
Mats LekanderStockholm UniversityCompleted
-
University of CopenhagenCompleted
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of ChicagoRecruitingOverweight or ObesityUnited States
-
Institut de Recherche Biomedicale des ArmeesUniversity of Paris 5 - Rene Descartes; Hotel Dieu de France HospitalNot yet recruitingCognitive Impairment | Sleep Deprivation
-
University of ChicagoCompletedChronic Kidney DiseaseUnited States
-
Woolcock Institute of Medical ResearchUniversity of Sydney; Cooperative Research Centre for Alertness, Safety and...RecruitingChronic Low-back Pain | InsomniaAustralia
-
Direction Centrale du Service de Santé des ArméesRecruitingSleep Disorder | Heat; ExcessFrance