Actively Recruiting
Noradrenergic Dysregulation, Sleep and Cognition in Older Adults With Insomnia
Led by Northwestern University · Updated on 2026-03-30
60
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study investigates the relationship between the noradrenergic (NA) system, sleep quality, and cognitive function in older adults with insomnia - a population at elevated risk for Alzheimer's disease-related dementias (ADRD) - compared to age and sex matched controls with normal sleep. The study characterizes NA function through multiple approaches: measuring 24-hour plasma levels of norepinephrine (NE) and its brain metabolite 3-methoxy-4-hydroxyphenylglycol (MHPG); evaluating central NA system response using the clonidine suppression test (a presynaptic α2 adrenoreceptor agonist that reduces locus coeruleus NA activity; and employing pupillometry as a non-invasive marker of autonomic function. To explore NA function's mechanistic role in insomnia, the study uses an intervention with bright light exposure to enhance daytime NA activity, with the goal of improving both sleep quality and cognitive performance.
CONDITIONS
Official Title
Noradrenergic Dysregulation, Sleep and Cognition in Older Adults With Insomnia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Independent in daily living activities with mini-mental status exam score 26 or higher
- Women must be postmenopausal
- Time spent in bed not more than 8.5 hours
- Sedentary: exercise less than 30 minutes per day and less than twice per week
- Average daily light exposure typical of indoor environments
- For insomnia group: meet chronic insomnia disorder criteria with subjective sleep efficiency under 85% or early awakening before 6 AM at least 3 nights per week
- For insomnia group: subjective wake after sleep onset (sWASO) 60 minutes or more at least 3 nights per week
- For insomnia group: global Pittsburgh Sleep Quality Index (PSQI) score over 5
- For control group: no history of chronic or short-term insomnia
- For control group: subjective sleep efficiency over 85%
- For control group: average total sleep time between 6.5 and 8 hours
- For control group: habitual bedtime between 9 PM and midnight
- For control group: PSQI score 5 or less
- Control group matched by age and sex within plus or minus 3 years
You will not qualify if you...
- Other sleep disorders such as restless legs syndrome, parasomnias, REM behavior disorder, circadian rhythm sleep-wake disorder, or sleep apnea with apnea hypopnea index 15 or higher
- Habitual bedtime before 9 PM or waking before 5 AM
- History of neurological or psychiatric disorders
- Beck Depression Inventory score over 19
- Unstable or serious medical conditions
- Prediabetes or diabetes with HbA1C 5.7 or higher
- Current or recent use (past month) of psychoactive, hypnotic, stimulant, or analgesic medications (except occasional use)
- Use of medications affecting noradrenergic system activity such as beta-blockers, SNRIs, or NDRIs
- Hormone replacement therapy
- Use of medications affecting pupil size or light response
- Visual problems interfering with pupillary response such as significant cataracts, narrow-angle glaucoma, or blindness
- History of heart conditions including arrhythmia, coronary artery disease, angina, or heart failure
- Shift work or irregular sleep schedules
- Body mass index over 35 kg/m2
- Habitual smoking of 6 or more cigarettes per week or caffeine intake over 400 mg per day
- Use of weight-loss medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
M
Marguerite McGuire
CONTACT
D
Daniela Grimaldi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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