Time in Bed Restriction for Amyloidosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amyloidosis+4 MoreTime in Bed Restriction - Behavioral
Eligibility
65 - 85
All Sexes
What conditions do you have?
Select

Study Summary

This trial will explore whether better sleep can help mitigate the effects of Alzheimer's disease.

Eligible Conditions
  • Mild Cognitive Impairment
  • Sleep
  • Amyloidosis
  • Alzheimer's Disease
  • Cognitive Impairment

Treatment Effectiveness

Study Objectives

6 Primary · 10 Secondary · Reporting Duration: Baseline

Baseline
Amyloid positivity status
Apolipoprotein (ApoE) e4 allele carrier status
Clinical insomnia status
Cognitive status based on neuropsychological adjudication
Baseline and 4 weeks
Change in mean Plasma amyloid-beta 1-42
Mean change in Hippocampal Activation
Mean change in Sleep Efficiency
Mean change in accuracy on executive function tasks
Mean change in delta activity during sleep
Mean change in medial temporal-Hippocampal Connectivity
Mean change in response time on executive function tasks
Mean change in slow-oscillation activity assessed with electroencephalography
Mean percent signal change in medial prefrontal activation
Medial prefrontal-Hippocampal Connectivity
Overnight memory retention on the AB paired associate task, preclinical Alzheimer's cognitive composite score
mean change in plasma amyloid-beta composite score

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
Time in Bed Restriction
1 of 2

Active Control

Experimental Treatment

116 Total Participants · 2 Treatment Groups

Primary Treatment: Time in Bed Restriction · No Placebo Group · N/A

Time in Bed RestrictionExperimental Group · 2 Interventions: Time in Bed Restriction, Sleep Schedule · Intervention Types: Behavioral, Behavioral
Control
Behavioral
ActiveComparator Group · 1 Intervention: Sleep Schedule · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,617 Previous Clinical Trials
16,295,326 Total Patients Enrolled
1 Trials studying Amyloidosis
82 Patients Enrolled for Amyloidosis
National Institute on Aging (NIA)NIH
1,413 Previous Clinical Trials
3,484,100 Total Patients Enrolled
5 Trials studying Amyloidosis
2,301 Patients Enrolled for Amyloidosis

Eligibility Criteria

Age 65 - 85 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have normal or corrected-to-normal visual and auditory acuity.