MedDataX Logo

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

NCT ID: NCT05138848

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of two intervention groups. The active group will limit their time in bed for 4 weeks by following a consistent sleep schedule with 85% time in bed compared to their baseline time in bed. The control group will not limit their time in bed, but will be asked to maintain their typical sleep schedule consistent with their baseline time in bed.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data collection and data reduction will be performed by sleep technicians and staff who are blind to study hypotheses and the randomization assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Time in Bed Restriction

Time in Bed (TIB) restriction of 85% of habitual TIB.

Group Type EXPERIMENTAL

Time in Bed Restriction

Intervention Type 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

Intervention Type BEHAVIORAL

Participants will maintain their typical sleep schedule for 4-weeks.

Control

Participants will follow their typical sleep schedule consistent with measured average sleep and wake times.

Group Type ACTIVE_COMPARATOR

Sleep Schedule

Intervention Type BEHAVIORAL

Participants will maintain their typical sleep schedule for 4-weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Time in Bed Restriction

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.

Intervention Type BEHAVIORAL

Sleep Schedule

Participants will maintain their typical sleep schedule for 4-weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 65-85.
2. Self-report mean sleep efficiency (the time in bed spent asleep within the time of lights out to final awakening) \< 90% based on diary and actigraphy estimates and wake time after sleep onset \> 20 minutes based on diary and actigraphy estimates.
3. Self-reported normal or corrected-to-normal visual and auditory acuity.

10. Apnea/hypopnea index greater than 15 as determined by one night of Apnea Link Plus screening.
11. Metal in the body. Rationale: Due to the nature of magnetic resonance imaging (MRI), participants cannot have any metal implants in their bodies, cannot have worked in a metal shop or been exposed to metal fragments during combat. Metal dental work (e.g. fillings crowns) may be allowed if compatible with the fMRI scanner.
12. Claustrophobia. Rationale: Could prevent the participant from completing the MRI scans.
13. Severe obesity. BMI \> 40. Rationale: Could prevent the participant from completing the MRI scan.
14. Near-miss or prior automobile accident "due to sleepiness" within the past 12 months. Rationale: reduces the risk of sleepiness-related accidents.
15. Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots). Rationale: reduces the risk of sleepiness-related accidents.
16. A score below 23 on the Telephone Interview for Cognitive Status. Rationale: This cut-off has been demonstrated to differentiate well between individuals with mild cognitive impairment from individuals with dementia who would have decision making impairments (Seo et al. 2011, Archives of Gerontology and Geriatrics). This ensures that decision making abilities are intact.
17. An Epworth sleepiness score greater than 10. Rationale: ensures that sleepiness is not excessive before starting the intervention that could further increase sleepiness. (Mazzotti, Diego R., et al. "Is the Epworth Sleepiness Scale sufficient to identify the excessively sleepy subtype of OSA?." Chest 161.2 (2022): 557-561; Aurora, R. Nisha, et al. "Correlating subjective and objective sleepiness: revisiting the association using survival analysis." Sleep 34.12 (2011): 1707-1714.)

Exclusion Criteria

1. Shift work involving night shift or regular work within the hours of 12am and 6am.
2. Presence of a chronic condition that significantly affects sleep.
3. Severe psychiatric condition including major depressive disorder, panic disorder, substance use disorders, and alcohol abuse/dependence within the past 6 months, or a lifetime history of a psychotic disorder or bipolar I disorder, based on initial online/phone self-report diagnoses, and subsequently based on a structured psychiatric interview.
4. Current use of medications affecting sleep such as antidepressants, antipsychotic medications, anticonvulsants, and steroids.
5. Current use of sedating drugs used at bedtime.
6. Consumption of \> 14 alcohol drinks per week or \> 6 drinks at a single sitting.
7. Consumption of \> 3 caffeine drinks per day.
8. Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, seizure disorder, delirium or dementia, a loss of consciousness \> 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with Alzheimer's disease based on neuropsychological testing will be excluded.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristine Wilckens

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UPMC Western Psychiatric Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kristine Wilckens, PhD.

Role: CONTACT

Phone: (412) 586-9434

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kristine Wilckens, PhD.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AG068001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY20110278

Identifier Type: -

Identifier Source: org_study_id