drugset / Trial / NCT04014387

Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)

NCT04014387

RandomizedCrossoverQuadruple-blindTreatment

Summary

Prior research has identified profound sleep disruption in individuals with PSP. Not only were these individuals sleeping relatively short periods at night, they were also not recuperating lost sleep during the day. Research also showed the relative preservation of a series of nuclei key in regulating wake and arousal. Investigators believe that therapeutically targeting wake promoting centers with a specific medication will improve sleep quality and overall well-being in PSP. To study this, investigators will be doing a double blind, within subject, remote clinical trial with 3 conditions: suvorexant- which targets a wake promoting system, zolpidem- a standard hypnotic that engages sleep promoting systems, versus placebo. Each condition will last 1 week and will be separated by a 1 week washout period on no sleep medications. Investigators will measure sleep patterns and daytime symptoms to determine if suvorexant, zolpidem, or both medications are safe and effective for treating sleep disturbances and improving overall well-being in PSP.

Timeline

Start
2019-06-02
Primary completion
2025-06-30
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Suvorexant Small molecule
Comparator Zolpidem Small molecule

Indications

No indication recorded.