SleepNCT03840083
Sleep-dependent Learning in Aging
A study testing Sleep in people with Sleep, run by University of Massachusetts, Amherst at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 yrs
- Healthy sleeper
- No diagnosed sleep or neurodegenerative disorder
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts
Amherst, Massachusetts, 01003
Mary Emma Searles, 413-545-4831, msearles@umass.edu
About this study
Official title: What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging
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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepBehavioural
Participants will sleep (either a mid-day nap or normal overnight sleep)
| Study group | Role | What they receive |
|---|---|---|
| Sleep | Experimental | Individuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6) Receives: Behavioral: Sleep |
| Wake | No intervention | Individuals will stay awake for the same amount of time as they slept in the sleep condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours (Experiments 1,4) or 12 hours (Experiments 2,3,5,6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start15 Jul 2018
- Primary completion14 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Spencer, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840083
- Sponsor's protocol ID
- 2017-4290
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is Sleep's Role in Alzheimer's Disease? Insight From Healthy Aging
- ClinicalTrials.gov ID
- NCT03840083
- Acronym / sponsor ID
- 2017-4290
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 14 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep | Experimental | Behavioral: SleepIndividuals will either nap (Exps 1, 4) or have overnight sleep (Exps 2, 3, 5, 6) |
| Wake | No intervention | –Individuals will stay awake for the same amount of time as they slept in the sleep condition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 yrs
- Healthy sleeper
- No diagnosed sleep or neurodegenerative disorder
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SleepParticipants will sleep (either a mid-day nap or normal overnight sleep) | Behavioural | Sleep |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Sleep
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Innovating CBT-I for Cancer Survivors: An Optimization Trial
Cancer Survivorship, Insomnia
RecruitingPhase 2
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
Major Depressive Disorder (MDD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep in people with Sleep, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.