Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05138848
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Alzheimer Disease, Late Onset
  • Amyloid
  • Cognitive Change
  • Mild Cognitive Impairment
  • Sleep

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Time in Bed Restriction — BEHAVIORAL
    Participants will undergo a 4-week sleep intervention that includes specified in- and out-of-bed times as well as a restriction to their habitual time in bed (average sleep opportunity including naps). This will be truncated equally at the beginning and end of the night.
  • Sleep Schedule — BEHAVIORAL
    Participants will maintain their typical sleep schedule for 4-weeks.

Study Details

Dementia caused by Alzheimer's disease affects approximately 5.6 million adults over age 65, with costs expected to rise from $307 billion to $1.5 trillion over the next 30 years. Behavioral interventions have shown promise for mitigating neurodegeneration and cognitive impairments. Sleep is a modifiable health behavior that is critical for cognition and deteriorates with advancing age and Alzheimer's disease. Thus, it is a priority to examine whether improving sleep modifies Alzheimer's disease pathophysiology and cognitive function. Extant research suggests that deeper, more consolidated sleep is positively associated with memory and executive functions and networks that underlie these processes. Preliminary studies confirm that time-in-bed restriction interventions increase sleep efficiency and non-rapid eye movement slow-wave activity (SWA) and suggest that increases in SWA are associated with improved cognitive function. SWA reflects synaptic downscaling predominantly among prefrontal connections. Downscaling of prefrontal connections with the hippocampus during sleep may help to preserve the long-range connections that support memory and cognitive function. In pre-clinical Alzheimer's disease, hyperactivation of the hippocampus is thought to be excitotoxic and is shown to leave neurons vulnerable to further amyloid deposition. Synaptic downscaling through SWA may mitigate the progression of Alzheimer's disease through these pathways. The proposed study will behaviorally increase sleep depth (SWA) through four weeks of time-in-bed restriction in older adults characterized on amyloid deposition and multiple factors associated with Alzheimer's disease risk. This study will examine whether behaviorally enhanced SWA reduces hippocampal hyperactivation, leading to improved task-related prefrontal-hippocampal connectivity, plasma amyloid levels, and cognitive function. This research addresses whether a simple, feasible, and scalable behavioral sleep intervention improves functional neuroimaging indices of excitotoxicity, Alzheimer's pathophysiology, and cognitive performance.

Key Dates

Start date
Jan 3, 2022
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Time in Bed Restriction
    Time in Bed (TIB) restriction of 85% of habitual TIB.
  • Active Comparator: Control
    Participants will follow their typical sleep schedule consistent with measured average sleep and wake times.

Primary Outcome Measure

Mean change in slow-oscillation activity assessed with electroencephalography [ Time Frame: Baseline and 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Western Psychiatric HospitalPittsburghPennsylvania15213
Kristine Wilckens, PhD.
[email protected]
412-586-9434
Daniel Buysse, M.D. (SUB_INVESTIGATOR)
Howard Aizenstein, M.D. (SUB_INVESTIGATOR)
Meryl Butters, PhD. (SUB_INVESTIGATOR)
Ann Cohen, PhD. (SUB_INVESTIGATOR)
Marie Anne Gebara, M.D. (SUB_INVESTIGATOR)
Brian Lopresti, M.C. (SUB_INVESTIGATOR)
James Mountz, M.D./PhD. (SUB_INVESTIGATOR)
M. Ilyas Kamboh, PhD. (SUB_INVESTIGATOR)
Meredith Wallace, PhD. (SUB_INVESTIGATOR)
Nathan Yates, PhD. (SUB_INVESTIGATOR)
Kristine Wilckens, PhD. (PRINCIPAL_INVESTIGATOR)
Andrea Weinstein, PhD. (SUB_INVESTIGATOR)

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By research site
UPMC Western Psychiatric Hospital· Pittsburgh, PA

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