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Sleep-dependent Learning in Aging

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ClinicalTrials.gov Identifier: NCT03840083
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Amherst

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE July 15, 2018
Estimated Primary Completion Date July 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03840083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep-dependent Learning in Aging
Official Title  ICMJE What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging
Brief Summary The specific objective of this proposed research is to understand whether deficits in sleep-dependent memory changes reflect age-related changes in sleep, memory, or both. The central hypothesis is that changes in both memory and sleep contribute to age-related changes in sleep-dependent memory processing. To this end, the investigators will investigate changes in learning following intervals of sleep (overnight and nap) and wake in young and older adults.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Sleep
Intervention  ICMJE Behavioral: Sleep
Participants will sleep (either a mid-day nap or normal overnight sleep)
Study Arms  ICMJE
  • Experimental: Sleep
    Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6)
    Intervention: Behavioral: Sleep
  • No Intervention: Wake
    Individuals will stay awake for the same amount of time as they slept in the sleep condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2019)
584
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2024
Estimated Primary Completion Date July 14, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-75 yrs
  • Healthy sleeper
  • No diagnosed sleep or neurodegenerative disorder

Exclusion Criteria:

  1. 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.
  2. Past diagnosis neurological illness or head injury
  3. Reported average sleep per night < 5 or > 9 hrs
  4. Current employment involving shift work or an inability to keep a regular sleep schedule during the week prior to testing
  5. Current use of psychotropic, recreational drugs, or sleep-altering medications (sleep medications, cold medicines within the past week, clonidine, sympathomimetic stimulants)
  6. Daily caffeine intake of > 4 cups (coffee, tea, colas)
  7. Weekly alcohol intake of > 10 cups
  8. Pregnancy or < 12 months post-partum
  9. History of bipolar disorder, mania, or current evidence of depression as measured by Beck Depression Inventory score > 25
  10. Abnormal sleep (e.g., shift work, travel across >2 time zones within the past 3 months).
  11. Diagnosis of any Axis I disorder, neurological illness or head injury (according to Demographic and Health History form);
  12. Score indicative of cognitive dysfunction (subtest scores < 40)
  13. Beck Depression Scale score indicative of depression (> 19).

Additionally, individuals will be excluded from magnetic resonance imaging studies (Exps 1, 4) for:

  1. Left handed or ambidextrous
  2. Claustrophobia
  3. Presence of metal (thoroughly screened via questionnaire and metal detector)
  4. Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03840083
Other Study ID Numbers  ICMJE 2017-4290
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Massachusetts, Amherst
Study Sponsor  ICMJE University of Massachusetts, Amherst
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Massachusetts, Amherst
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP