drugset / Trial / NCT03077620

Sleep Quality and Amyloid-Beta Kinetics

NCT03077620 ↗

RandomizedParallel-groupSingle-blindOther

Summary

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.

Timeline

Start
2016-11
Primary completion
2021-03-28
Completion
2021-03-30

Outcome

Missed primary endpoint

registry analysis (superiority test); Poor Sleep Group Control vs Good Sleep Group; p = 0.05; Mean Difference (Final Values) 0.119 (95% CI -0.017 to 0.256); NCT03077620 ↗

registry analysis (superiority test); Poor Sleep Group Control vs Poor Sleep Group Treatment 1; p = 0.05; Mean Difference (Final Values) 0.004 (95% CI -0.078 to 0.087); NCT03077620 ↗

registry analysis (superiority test); Poor Sleep Group Control vs Poor Sleep Group Treatment 2; p = 0.05; Mean Difference (Final Values) 0.033 (95% CI -0.051 to 0.117); NCT03077620 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Suvorexant Small molecule 10 mg —
Subject Suvorexant Small molecule 20 mg —

Indications

No indication recorded.