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Sleep therapy may boost brain health in seniors with insomnia

NCT ID NCT03954210

Symptom relief Sponsor: University of Kansas Medical Center Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a six-week sleep therapy program (CBT-I) could improve thinking and memory in older adults aged 60-85 with insomnia. Two hundred participants were randomly assigned to either CBT-I or a sleep education program. A small group also had brain scans to see if better sleep slowed the buildup of amyloid plaques, which are linked to Alzheimer's disease. The goal was to see if treating insomnia could help protect 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
Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If successful, this could show that treating insomnia improves cognitive function and may slow brain changes linked to Alzheimer's disease.
What could go wrong
This is a completed study with 200 participants, but the results are not yet widely confirmed. The link between sleep and brain amyloid is still uncertain, and individual results may vary.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Aug 2019

Finished

Apr 2025

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

60 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: * Report of difficulty falling asleep, maintaining sleep, or waking up too early at least three nights a week for the past six months * A score of greater than, or equal to, ten on the Insomnia Severity Index * A score of greater than, or equal to, twenty-five on the Mini-Mental State Examination (MMSE) * A score of less than, or equal to, two on the Dementia Screening Interview (AD8) Exclusion Criteria: * A known untreated sleep disorder (i.e., sleep apnea or restless leg syndrome) * Currently taking benzodiazepines, non-benzodiazepines, melatonin supplements, or agonists for insomnia * A score of greater than, or equal to, fifteen on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of any suicidal ideation (an answer of one, two, or three on item number nine of the PHQ-9) * History of drug or alcohol abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-4) criteria within the last two years * History of a nervous system disorder (i.e., stroke, Parkinson's Disease) * Severe mental illness (i.e., Schizophrenia, Bipolar Disorder) * History of a learning disability or attention-deficit/hyperactivity disorder * Current, or history of, shift work * Currently receiving CBT-I treatment * Unable to hear at a conversational level * Failure of a near vision test utilizing the Logarithmic Near Visual Acuity Chart

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Conditions

The condition(s) this trial relates to.

Alzheimer disease insomnia

As listed by the trial registrant

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

Insomnia

Contacts and locations

Locations

  • University of Kansas Medical Center- Sleep, Health and Wellness Laboratory

    Kansas City, Kansas, 66160, United States

More trials for these conditions

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