Noradrenergic Dysregulation, Sleep and Cognition in Older Adults with Insomnia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: t
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• Age ≥ 55 years;

• Independent in activities of daily living and without clinically significant cognitive impairment as determined by a mini-mental status examination (MMSE) score ≥ 26;

• Due to the effect of reproductive hormones on autonomic regulation, sleep and cognition, women will be postmenopausal;

• time spent in bed not greater than 8.5 hours;

• 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.

• average daily light exposure indicative of indoor environments (from questionnaire).

• Meet criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.);

• Subjective sleep efficiency less than 80% and/or awakening earlier than desired if before 6 AM for ≥3 nights/week in the previous 4 weeks;

• 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;

• global PSQI score greater than 5;

• average daily light exposure indicative of indoor environments (from questionnaire).

• No history of chronic or short-term insomnia disorder according to the International Classification of Sleep Disorders (3rd Ed.);

• Subjective sleep efficiency greater than 80%;

• Subjective mean total sleep time of 6.5 hours to 8 hours;

• Habitual bedtime of 9PM-midnight;

• PSQI score ≤ 5. Participants in the control group will be matched with the insomnia group on sex and age (±3 years).

Locations
United States
Illinois
Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep Medicine
RECRUITING
Chicago
Contact Information
Primary
Marguerite McGuire
marguerite.mcguire@northwestern.edu
844-707-5337
Backup
Daniela Grimaldi, MD, PhD
daniela.grimaldi@northwestern.edu
844-707-5337
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 60
Treatments
Experimental: Intervention on Subjects with Insomnia
The intervention in this study will involve 28 (+4) days of daily exposure to bright light (BL) for two 60-minute sessions (morning and afternoon).~For the intervention, we will use Re-Timer® light glasses emitting light with an intensity of 230μW/cm2 (\~500lux) with a green blue 500nm dominant wavelength (between 480-520nm). Light with these characteristics has been shown effective in suppressing melatonin levels supporting their potential to exert effects on other biological non-visual functions associated with exposure to light relevant for this study.~Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects.
Active_comparator: Dim Red Light
Participants randomized to the control group will wear for two 60-minute sessions (morning and afternoon) customized dim-red light (RL) control Re-Timer® light glasses (wavelength peak at 632nm, light intensity \< 3 lux). Participants will be instructed to wear the light glasses in habitual indoor environments, without engaging in strenuous activities. Throughout the intervention, participants will keep a diary to monitor daily use of the glasses. Participants will have weekly phone calls with the research team to encourage compliance and monitor potential side effects.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Northwestern University

This content was sourced from clinicaltrials.gov