- Study Directors: Thomas Neylan, MD and Christine Walsh, PhD
- Sponsor: University of California, San Francisco
- Status: Recruiting
- Official Study Title: Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
- ClinicalTrials.gov Identifier: NCT04014387
- Conditions Studied: Progressive supranuclear palsy (PSP)
- Intervention: Suvorexant, Zolpidem and placebo control
- Phase: Phase 4
- Duration of Participation: 6 weeks
Purpose of the Study
The primary objective of this study is to assess the clinical efficacy of two hypnotic drugs as measured by the change in sleep and general functioning of an individual with PSP following treatment. In addition, this study will look at whether Suvorexant, compared to Zolpidem, is more effective for sleep disturbances in PSP. This study will also test the acceptability of and feasibility of doing a remote clinical trial, lowering participant burden so that all measures can be done at home, relying on internet/phone-based assessment methods and wearable technology. No participant or caregiver will be required to go to an assessment clinic throughout the study for assessments.
Eligibility
Inclusion Criteria: Participants must have documentation of a PSP diagnosis, be over the age of 18, have a caregiver who is willing to participate, speak English, and have a stable residence and medication history.
Exclusion Criteria: Participants must not have been diagnosed with a major psychiatric disorder, have a neurological condition other than the one being studied, have substance abuse or dependence, or be taking a medication likely to affect sleep outcomes.
What to Expect
Testing: Participants will be asked to complete a variety of questionnaires, interviews, and cognitive assessments with the study staff through the phone or video call and wear sleep-measuring devices.
The Frequency of Visits: This is a fully remote study. Participants will be screened by phone. If eligible, participants will be mailed a package with medications, assessments, and sleep assessment equipment. Participants will check in with study staff by phone or video 1–5 times a week.
Costs: During the study drug weeks, participants may benefit from participating in the study, but this cannot be guaranteed. In return for time, effort, and expenses, participants will be paid $125. There will be no additional cost for participation.
Contact Information
Study Director: Christine Walsh, PhD – [email protected]
