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Sleep hack may slow Alzheimer's: early study tests Time-in-Bed restriction

NCT ID NCT05138848

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests whether spending less time in bed for four weeks can deepen sleep and boost memory in adults aged 65-85 who have poor sleep and are at risk for Alzheimer's. Researchers will measure brain activity, memory, and blood markers. The goal is to see if a simple behavioral change can reduce Alzheimer's-related brain changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Time in bed restriction (behavioral sleep intervention)
What this could lead to
If it works, this could point toward a simple, drug-free way to slow Alzheimer's-related memory decline by improving sleep quality.
What could go wrong
This is a very early, small study (116 people) testing a behavioral change, not a treatment. Results may not lead to a proven therapy, and sleep restriction can be uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

99 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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. 9. Sleep efficiency \> 90% and wake time after sleep onset \< 20 minutes consistent with the rationale of the inclusion criteria described above. 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.)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • UPMC Western Psychiatric Hospital

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.