Actively Recruiting

Early Phase 1
Age: 65Years - 85Years
All Genders
Healthy Volunteers
ID05138848

Slow-wave Sleep Enhancement in Older Adults at Risk for Alzheimer's Disease: Effects on Memory, Brain Activity, and Plasma Amyloid-Beta

Led by University of Pittsburgh · Updated on 2025-12-19

116

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Dementia caused by Alzheimer's disease affects millions of adults over age 65, and the costs of managing this condition are expected to rise significantly in the coming decades. Sleep is an important factor for brain health and cognition that tends to worsen with age and Alzheimer's disease. This research aims to study whether improving deep sleep can influence Alzheimer's disease-related brain changes and cognitive function by using a behavioral sleep intervention in older adults at risk for the disease. The study compares two groups over four weeks: one group will have their time in bed restricted to 85% of their usual sleep time, aiming to enhance slow-wave sleep (deep sleep), while the other group will maintain their typical sleep schedule. The intervention involves adjusting sleep and wake times equally at the beginning and end of the night to promote deeper sleep. This trial is randomized and single-blinded, focusing on changes in brain activity, plasma amyloid levels, and memory performance. Participants will undergo assessments at the start and after four weeks, including brain scans, blood tests, and cognitive memory tests. Researchers will measure slow-wave sleep activity, hippocampal activation, plasma amyloid-beta levels, and overnight memory retention. Additional sleep and brain connectivity metrics will be evaluated. Safety and adherence will be monitored throughout the trial, which includes participants aged 65 to 85 with sleep difficulties and normal or corrected vision and hearing.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 65 and 85 years
  • Self-reported sleep efficiency less than 90% and wake time after sleep onset greater than 20 minutes based on diary and actigraphy
  • Normal or corrected-to-normal vision and hearing
Not Eligible

You will not qualify if you...

  • Night shift work or regular work between 12am and 6am
  • Chronic conditions that significantly affect sleep
  • Severe psychiatric disorders including recent major depression, panic disorder, substance use, psychotic disorders, or bipolar I disorder
  • Use of medications affecting sleep such as antidepressants, antipsychotics, anticonvulsants, steroids, or sedatives
  • Alcohol consumption over 14 drinks per week or more than 6 drinks at once
  • Caffeine intake over 3 drinks per day
  • Diagnosis of central nervous system diseases including Alzheimer's disease or related dementias
  • Sleep efficiency above 90% or wake time after sleep onset less than 20 minutes
  • Apnea/hypopnea index greater than 15 from sleep screening
  • Metal implants or exposure preventing MRI
  • Claustrophobia
  • Severe obesity with BMI over 40
  • Recent near-miss or accident due to sleepiness
  • Employment as commercial driver
  • Cognitive status score below 23 on Telephone Interview for Cognitive Status
  • Epworth sleepiness score above 10 indicating excessive daytime sleepiness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - 4 weeks

Participants undergo a 4-week sleep intervention involving either restricted time in bed or maintaining their typical sleep schedule.

1 baseline visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

UPMC Western Psychiatric Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

K

Kristine Wilckens, PhD.

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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Published Research Related To This Trial

The Alzheimer's Pathways Sleep Study (ALPS): an experimental randomized controlled trial to improve cognition and Alzheimer's pathophysiology through slow-wave sleep.

Yue C Dong, Rima F Habte, Kibra M Dessa...

https://pubmed.ncbi.nlm.nih.gov/41715219