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NCT05138848 · ClinicalTrials.gov registry record · Early Phase 1
Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease
A Early Phase 1 study of Mild Cognitive Impairment and Sleep, sponsored by University of Pittsburgh.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 116
- Enrollment target
- 1
- Study location
NCT05138848: Recruiting Early Phase 1 study of Mild Cognitive Impairment and Sleep, sponsored by University of Pittsburgh.
NCT05138848 is a Early Phase 1 study of Mild Cognitive Impairment and Sleep that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 116 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05138848, a Early Phase 1 study of Mild Cognitive Impairment and Sleep, is actively recruiting participants, sponsored by University of Pittsburgh.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 116 participants
- Enrollment target
- 1
- Study location
Study Summary
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 impr
Primary Outcome
Slow oscillation electroencephalographic power (0.5-1 Hz) during non-rapid eye movement sleep
Conditions Studied
Interventions
- BEHAVIORAL Time in Bed Restriction
- BEHAVIORAL Sleep Schedule
Study Locations (1)
Pennsylvania
- UPMC Western Psychiatric Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2022-01-03 |
| Est. Completion | 2026-05-31 |
| Phase | Early Phase 1 |
What NCT05138848 shows while recruiting
NCT05138848 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Time in Bed Restriction is the first listed.
NCT05138848 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05138848 about?
NCT05138848 is a clinical study titled "Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease". 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 modif...
What is the current status of trial NCT05138848?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 116 participants. The study started on 2022-01-03. Estimated completion is 2026-05-31.
What conditions does trial NCT05138848 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Sleep, Cognitive Change, Alzheimer Disease, Late Onset, Amyloid.
What interventions are being tested in trial NCT05138848?
The interventions under investigation include: Time in Bed Restriction (BEHAVIORAL), Sleep Schedule (BEHAVIORAL).
Who is sponsoring clinical trial NCT05138848?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05138848 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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116 85th of 205 higher than 121 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
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