Improving sleep in older adults at risk for Alzheimer's disease

Slow-wave Sleep Enhancement in Those at Risk for Alzheimer's Disease: Links With Memory, Excitotoxicity, and Plasma A-beta

This study tests if limiting time in bed can help older adults at risk for Alzheimer's sleep better and improve their thinking skills.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05138848 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of time-in-bed restriction on sleep quality and cognitive function in older adults aged 65-85 who experience sleep difficulties and may be at risk for Alzheimer's disease. The intervention aims to enhance sleep efficiency and increase non-rapid eye movement slow-wave activity, which is linked to better cognitive performance. Participants will be monitored using sleep diaries and actigraphy to assess their sleep patterns and cognitive changes throughout the intervention. The study seeks to determine whether improving sleep can positively influence Alzheimer's disease pathophysiology and cognitive health.

Who should consider this trial

Good fit: Ideal candidates are older adults aged 65-85 who report poor sleep efficiency and have difficulties with sleep.

Not a fit: Patients with severe psychiatric conditions or chronic illnesses that significantly affect sleep may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to improved sleep quality and cognitive function in older adults, potentially delaying the onset or progression of Alzheimer's disease.

How similar studies have performed: Preliminary studies have shown promise in using sleep interventions to improve cognitive function, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. Age 65-85.
2. Self-report mean sleep efficiency (the time in bed spent asleep within the time of lights out to final awakening) \< 90% based on diary and actigraphy estimates and wake time after sleep onset \> 20 minutes based on diary and actigraphy estimates.
3. Self-reported normal or corrected-to-normal visual and auditory acuity.

Exclusion Criteria:

1. Shift work involving night shift or regular work within the hours of 12am and 6am.
2. Presence of a chronic condition that significantly affects sleep.
3. Severe psychiatric condition including major depressive disorder, panic disorder, substance use disorders, and alcohol abuse/dependence within the past 6 months, or a lifetime history of a psychotic disorder or bipolar I disorder, based on initial online/phone self-report diagnoses, and subsequently based on a structured psychiatric interview.
4. Current use of medications affecting sleep such as antidepressants, antipsychotic medications, anticonvulsants, and steroids.
5. Current use of sedating drugs used at bedtime.
6. Consumption of \> 14 alcohol drinks per week or \> 6 drinks at a single sitting.
7. Consumption of \> 3 caffeine drinks per day.
8. Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, seizure disorder, delirium or dementia, a loss of consciousness \> 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with Alzheimer's disease based on neuropsychological testing will be excluded.
9. Sleep efficiency \> 90% and wake time after sleep onset \< 20 minutes consistent with the rationale of the inclusion criteria described above.
10. Apnea/hypopnea index greater than 15 as determined by one night of Apnea Link Plus screening.
11. Metal in the body. Rationale: Due to the nature of magnetic resonance imaging (MRI), participants cannot have any metal implants in their bodies, cannot have worked in a metal shop or been exposed to metal fragments during combat. Metal dental work (e.g. fillings crowns) may be allowed if compatible with the fMRI scanner.
12. Claustrophobia. Rationale: Could prevent the participant from completing the MRI scans.
13. Severe obesity. BMI \> 40. Rationale: Could prevent the participant from completing the MRI scan.
14. Near-miss or prior automobile accident "due to sleepiness" within the past 12 months. Rationale: reduces the risk of sleepiness-related accidents.
15. Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots). Rationale: reduces the risk of sleepiness-related accidents.
16. A score below 23 on the Telephone Interview for Cognitive Status. Rationale: This cut-off has been demonstrated to differentiate well between individuals with mild cognitive impairment from individuals with dementia who would have decision making impairments (Seo et al. 2011, Archives of Gerontology and Geriatrics). This ensures that decision making abilities are intact.
17. An Epworth sleepiness score greater than 10. Rationale: ensures that sleepiness is not excessive before starting the intervention that could further increase sleepiness. (Mazzotti, Diego R., et al. "Is the Epworth Sleepiness Scale sufficient to identify the excessively sleepy subtype of OSA?." Chest 161.2 (2022): 557-561; Aurora, R. Nisha, et al. "Correlating subjective and objective sleepiness: revisiting the association using survival analysis." Sleep 34.12 (2011): 1707-1714.)

Where this trial is running

Pittsburgh, Pennsylvania

• UPMC Western Psychiatric Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Kristine Wilckens, PhD.

Conditions Alzheimer Disease, Late Onset; Mild Cognitive Impairment; Sleep; Cognitive Change; Amyloid