Investigating sleep and cognition in older adults with insomnia

Noradrenergic Dysregulation, Sleep and Cognition in Older Adults With Insomnia

This study tests how a new light therapy can improve sleep and thinking skills in older adults with insomnia, who are at risk for memory problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: Northwestern University (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06694441 on ClinicalTrials.gov

What this trial studies

This study explores how the noradrenergic system affects sleep quality and cognitive function in older adults suffering from insomnia, a group at higher risk for Alzheimer's disease-related dementias. It compares these individuals to age and sex-matched controls with normal sleep patterns. The research employs various methods to assess noradrenergic function, including measuring plasma norepinephrine levels and using a clonidine suppression test. Additionally, the study tests the effects of bright light exposure as an intervention to enhance daytime noradrenergic activity, aiming to improve both sleep and cognitive performance.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 55 and above who experience chronic insomnia and meet specific cognitive and lifestyle criteria.

Not a fit: Patients with significant cognitive impairment or those who do not meet the criteria for chronic insomnia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for insomnia in older adults, potentially enhancing their cognitive function and quality of life.

How similar studies have performed: Other studies have shown promising results in exploring the relationship between sleep, cognition, and noradrenergic function, suggesting this approach has potential.

Eligibility criteria

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

Where this trial is running

Chicago, Illinois

• Northwestern University Feinberg School of Medicine, Center for Circadian and Sleep Medicine — Chicago, Illinois, United States (Recruiting)

Study contacts

• Principal investigator: Daniela Grimaldi, MD, PhD — Northwestern University
• Study coordinator: Marguerite McGuire

Conditions Insomnia; Older Adults; Noradrenergic dysregulation; sleep; cognition; cognitive function