Sleep Clinical Trial
Official title:
What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging
| 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 |
| Verified date | March 2019 |
| Source | University of Massachusetts, Amherst |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Massachusetts | Amherst | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| University of Massachusetts, Amherst |
United States,
| 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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