Scientists probe Brain's 'Alertness' chemical in older insomniacs to fight dementia
NCT ID NCT06694441
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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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
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
Locations
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Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep Medicine
RECRUITINGChicago, Illinois, 60611, United States
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