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Does sleep clean your brain? new study investigates

NCT ID NCT02669225

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 18 times

Summary

This study looked at whether sleep helps the brain clear out a waste product called amyloid-beta, which is linked to Alzheimer's disease. Twenty-two healthy adults had brain scans after a full night's sleep and after being kept awake all night. The goal was to see if sleep affects how much amyloid-beta builds up in the brain.

What this could mean

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

Active substance
[18F]florbetaben (PET radiotracer)
What this could lead to
If successful, this study could help explain how sleep helps clear brain waste, potentially pointing to ways to reduce Alzheimer's risk.
What could go wrong
This is a very early, small study in healthy people, not a treatment trial. Results may not apply to those with sleep disorders or Alzheimer's.

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

22 people

The number who actually took part.

Started

May 2016

Finished

Jul 2018

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Male or females. 2. Young group (18-40 years of age) 3. Older group (\>40 years of age) 4. Ability to provide written informed consent EXCLUSION CRITERIA: 1. Pregnant and/or breast feeding. Females of childbearing potential must have negative urine pregnancy test and not be currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy) females satisfy these criteria. 2. Positive urine drug test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) on each visit involving imaging studies and/or neuropsychological assessment. 3. Head trauma with loss of consciousness for more than 30 minutes as determined by self-report and/or medical history. 4. Subjects with problematic insomnia as determined by self-report (reports having trouble sleeping on most days). 5. Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a CPAP machine, sleeping during the day, using medication to fall asleep, sleeps less than 5 hours per night, night shift workers) as determined by self-report and/or medical history. 6. Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, antidepressants, antipsychotics, benzodiazepines and barbiturates, stimulants) as determined by self-report and/or medical history. 7. Current DSM 5 diagnosis of affective disorder, addiction (other than nicotine of caffeine), PTSD, or schizophrenia. 8. Individuals with cognitive impairment as identified with a score of lower than 24 in the MMSE will be excluded. Further, individuals with impairment sufficient to affect consent capacity even if MMSE is less than 24 will be excluded. We will consult the Ability to Consent Assessment Team (ACAT) in those whose capacity to consent may be questionable. 9. Severe medical problems that can permanently impact brain function (e.g., problems of the CNS; cardiovascular; metabolic, autoimmune, endocrine) as determined by history and clinical exam. 10. Individuals with a medical history of a neurodegenerative disease. 11. Heavy alcohol users. Heavy alcohol users are those individuals who consume more than 5 drinks in one seating (if males) or more than 4 drinks in one seating (if females) more than twice a week will be excluded. 12. Uncontrolled hypertension. 13. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist. 14. Fear of enclosed spaces (claustrophobia) as determined by self-report and medical history. 15. Cannot lie comfortably flat on the back for up to 2 hours in the MRI scanner as determined by self-report. 16. Body weight \> 250 kg. This is the upper limit that the bed of the MR scanner can accommodate (clinical exam). 17. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam. 18. Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).

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Conditions

The condition(s) this trial relates to.

Sleep Deprivation

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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