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Scientists probe Brain's 'Alertness' chemical in older insomniacs to fight dementia

NCT ID NCT06694441

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at how a brain chemical called norepinephrine affects sleep and thinking in older adults with insomnia, who are at higher risk for Alzheimer's. Researchers will measure this chemical in the blood and use a light therapy to try to improve sleep and mental sharpness. The goal is to understand the link between poor sleep, brain chemistry, and memory decline.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Aug 2029

An estimate. End dates often move.

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

55 years and older

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 ≥ 55 years; 2. Independent in activities of daily living and without clinically significant cognitive impairment as determined by a mini-mental status examination (MMSE) score ≥ 26; 3. Due to the effect of reproductive hormones on autonomic regulation, sleep and cognition, women will be postmenopausal; 4. time spent in bed not greater than 8.5 hours; 5. Sedentary, defined as participation in exercise of moderate intensity for less than 30 minutes per day and less than two times per week on a regular basis. 6. average daily light exposure indicative of indoor environments (from questionnaire). Inclusion criteria for the insomnia group: 1. Meet criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.); 2. Subjective sleep efficiency less than 85% and/or awakening earlier than desired if before 6 AM for ≥3 nights/week in the previous 4 weeks; 3. Subjective WASO (sWASO) ≥ 60 minutes for ≥3 nights/week in previous 4 weeks. sWASO will include time spent awake after sleep onset before final awakening + time spent awake in bed attempting to sleep after the final awakening; 4. global PSQI score greater than 5; 5. average daily light exposure indicative of indoor environments (from questionnaire). Inclusion criteria for the control group: 1. No history of chronic or short-term insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.); 2. Subjective sleep efficiency greater than 85%; 3. Subjective mean total sleep time of 6.5 hours to 8 hours; 4. Habitual bedtime of 9PM-midnight; 5. PSQI score ≤ 5. Participants in the control group will be matched with the insomnia group on sex and age (±3 years). Exclusion Criteria: 1. Sleep disorders other than insomnia (restless legs syndrome, parasomnias, REM behavior disorder, circadian rhythm sleep-wake disorder, sleep apnea by STOP questionnaire and apnea hypopnea index (AHI) ≥ 15 by home sleep apnea test; 2. habitual bedtime before 9pm or morning awakening before 5am; 3. History of neurological disorders; 4. History of psychiatric disorders; 5. A Beck depression inventory ((BDI-II) score greater than 19); 6. Unstable or serious medical conditions; 7. Prediabetes and diabetes (HbA1C ≥ 5.7) 8. Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally); 9. Use of medications that interfere with NA system activity including B-blockers, selective serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective norepinephrine-dopamine reuptake inhibitors (NDRIs); 10. Hormone replacement therapy; 11. Use of medications that affects pupil diameter and responses to light (i.e. antihistamines, anticholinergics, benzodiazepines, narcotics for pain; 12. History of visual abnormalities that may interfere with pupillary responses to light exposure such as significant cataracts, narrow-angle glaucoma or blindness; 13. History of heart conditions (i.e. arrhythmia, coronary artery disease, angina, heart failure); 14. Shift work or other types of self-imposed irregular sleep schedules; 15. BMI \> 35 kg/m2; 16. History of habitual smoking (6 or more cigarettes/week) or caffeine consumption \> 400 mg/day. 17.Use of weight-loss medications

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

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