<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840083</url>
  </required_header>
  <id_info>
    <org_study_id>2017-4290</org_study_id>
    <nct_id>NCT03840083</nct_id>
  </id_info>
  <brief_title>Sleep-dependent Learning in Aging</brief_title>
  <official_title>What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Amherst</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Massachusetts, Amherst</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific objective of this proposed research is to understand whether deficits in&#xD;
      sleep-dependent memory changes reflect age-related changes in sleep, memory, or both. The&#xD;
      central hypothesis is that changes in both memory and sleep contribute to age-related changes&#xD;
      in sleep-dependent memory processing. To this end, the investigators will investigate changes&#xD;
      in learning following intervals of sleep (overnight and nap) and wake in young and older&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exp 1: Using neuroimaging, the investigators will consider whether differences in brain areas&#xD;
      engaged during memory encoding contribute to age-related changes in sleep-dependent memory&#xD;
      consolidation for a word-pair learning task.&#xD;
&#xD;
      Exp 2: The investigators will examine the rate of memory decay between encoding and sleep&#xD;
      using two probes of declarative memory (word-pair learning and visuo-spatial learning).&#xD;
&#xD;
      Exp 3: The investigators will provide additional opportunity for encoding of the word-pair&#xD;
      and visuo-spatial learning tasks.&#xD;
&#xD;
      Exp 4: Using neuroimaging, the investigators will examine neural engagement during encoding&#xD;
      and performance following intervals of sleep and wake.&#xD;
&#xD;
      Exp 5: The investigators will examine the rate of decay of motor sequence learning.&#xD;
&#xD;
      Exp 6: The investigators will examine whether enhanced training ('overtraining') improves&#xD;
      sleep-dependent memory consolidation for older adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2018</start_date>
  <completion_date type="Anticipated">July 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 14, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in memory accuracy for intervention compared to control</measure>
    <time_frame>2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">584</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wake</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals will stay awake for the same amount of time as they slept in the sleep condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep</intervention_name>
    <description>Participants will sleep (either a mid-day nap or normal overnight sleep)</description>
    <arm_group_label>Sleep</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-75 yrs&#xD;
&#xD;
          -  Healthy sleeper&#xD;
&#xD;
          -  No diagnosed sleep or neurodegenerative disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Past diagnosis of any sleep disorder or evidence of a sleep disorder as assessed by&#xD;
             self-reported sleep quality assessments, a standardized diagnostic interview, and an&#xD;
             acclimation night of polysomnography. Using acclimation-night polysomnography,&#xD;
             participants will be excluded with an Apnea-Hypopnea Index &gt;15; a Period-Limb Movement&#xD;
             in Sleep index of &gt;15/hr; sleep-onset latency &gt; 45 min (indicative of insomnia); or&#xD;
             sleep efficiency &lt; 80% (see Edinger et al., Sleep, 2004). In cases in which questions&#xD;
             arise regarding a participants' inclusion or sleep records, a practicing neurologist&#xD;
             board-certified in sleep medicine will review the documentation.&#xD;
&#xD;
          2. Past diagnosis neurological illness or head injury&#xD;
&#xD;
          3. Reported average sleep per night &lt; 5 or &gt; 9 hrs&#xD;
&#xD;
          4. Current employment involving shift work or an inability to keep a regular sleep&#xD;
             schedule during the week prior to testing&#xD;
&#xD;
          5. Current use of psychotropic, recreational drugs, or sleep-altering medications (sleep&#xD;
             medications, cold medicines within the past week, clonidine, sympathomimetic&#xD;
             stimulants)&#xD;
&#xD;
          6. Daily caffeine intake of &gt; 4 cups (coffee, tea, colas)&#xD;
&#xD;
          7. Weekly alcohol intake of &gt; 10 cups&#xD;
&#xD;
          8. Pregnancy or &lt; 12 months post-partum&#xD;
&#xD;
          9. History of bipolar disorder, mania, or current evidence of depression as measured by&#xD;
             Beck Depression Inventory score &gt; 25&#xD;
&#xD;
         10. Abnormal sleep (e.g., shift work, travel across &gt;2 time zones within the past 3&#xD;
             months).&#xD;
&#xD;
         11. Diagnosis of any Axis I disorder, neurological illness or head injury (according to&#xD;
             Demographic and Health History form);&#xD;
&#xD;
         12. Score indicative of cognitive dysfunction (subtest scores &lt; 40)&#xD;
&#xD;
         13. Beck Depression Scale score indicative of depression (&gt; 19).&#xD;
&#xD;
        Additionally, individuals will be excluded from magnetic resonance imaging studies (Exps 1,&#xD;
        4) for:&#xD;
&#xD;
          1. Left handed or ambidextrous&#xD;
&#xD;
          2. Claustrophobia&#xD;
&#xD;
          3. Presence of metal (thoroughly screened via questionnaire and metal detector)&#xD;
&#xD;
          4. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Massachusetts</name>
      <address>
        <city>Amherst</city>
        <state>Massachusetts</state>
        <zip>01003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Emma Searles</last_name>
      <phone>413-545-4831</phone>
      <email>msearles@umass.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840083
org study id: 2017-4290
nct id: NCT03840083
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in memory accuracy for intervention compared to control
time frame: 2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)
description: 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.
arm group label: Sleep
arm group type: Experimental
description: Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6)
arm group label: Wake
arm group type: No Intervention
description: Individuals will stay awake for the same amount of time as they slept in the sleep condition
intervention type: Behavioral
intervention name: Sleep
description: Participants will sleep (either a mid-day nap or normal overnight sleep)
arm group label: Sleep
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: No