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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03840083
Other study ID # 2017-4290
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2018
Est. completion date July 15, 2024

Study information

Verified date March 2019
Source University of Massachusetts, Amherst
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 584
Est. completion date July 15, 2024
Est. primary completion date July 14, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep
Participants will sleep (either a mid-day nap or normal overnight sleep)

Locations

Country Name City State
United States University of Massachusetts Amherst Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in memory accuracy for intervention compared to control 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)
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