Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease

Launched by UNIVERSITY OF PITTSBURGH · Nov 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a simple change in sleep habits can help improve cognitive function in older adults who have sleep difficulties and may be at risk for Alzheimer's disease. Researchers believe that getting deeper and more restful sleep could help protect memory and brain connections that are important for thinking and remembering. The trial will involve restricting time in bed for four weeks, which aims to enhance the quality of sleep and may lead to better brain health and cognitive abilities.

To participate in this study, individuals must be between 65 and 85 years old and have trouble sleeping, specifically spending less than 90% of their time in bed actually asleep. They should not have severe sleep disorders or major psychiatric conditions, and certain medications that affect sleep are not allowed. Participants can expect to follow a structured sleep schedule and will be monitored for changes in their sleep patterns and cognitive function. This trial represents an exciting opportunity to explore how improving sleep could support brain health in older adults.

Gender

ALL

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.)