Status:
COMPLETED
Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
US Department of Veterans Affairs
Conditions:
Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Male or female ≥18 years of age at baseline.
- Documentation of a Progressive Supranuclear Palsy diagnosis as evidenced by one or more clinical features consistent with the Progressive Supranuclear Palsy phenotype as described in the Movement Disorder Society criteria or the NINDS-SPSP criteria.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Have a diagnosis of PSP verified through co-enrollment in ARTFL, LEFFTDS or 4RTNI, or can show evidence of an accurate diagnosis of PSP to the satisfaction of the study team doctor (e.g. through review of medical records, and/or specific communication with a known medical doctor).
- Have an active caregiver who is willing and able to participate in this study
- Have a mailing address
- Have access to a phone
- Have stable medications (aside from sleep-modifying medications) for 4 weeks prior to actively starting the study
- Be free of sleep modifying medications for 1 week prior to actively starting the study
- Be willing to maintain a stable sleeping environment and their typical daily schedule for the duration of the 6-week study
- Resides in a US territory or state covered by our research study team.
Exclusion
- Are pregnant, breastfeeding, or unwilling to practice birth control if appropriate during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Presence of a major psychiatric disorder aside from anxiety or depression.
- Presence of a medical condition other than PSP that could account for cognitive deficits (e.g. active seizure disorder, stroke, vascular dementia).
- Presence of current substance abuse or substance dependence.
- Presence of a significant systemic medical illness (e.g. significant cardiovascular, hematologic, renal, or hepatic disease).
- Presence of current medication likely to affect sleep outcomes: benzodiazepine receptor agonists (e.g. Zolpidem), Suvorexant, sedating antipsychotics (e.g. Quetiapine), sedating antihistamines (e.g. Benadryl), low dose sedating antidepressants (e.g. Trazodone, Doxepin), over the counter sleep-inducing medications (e.g. Tylenol-PM), neuroleptics in the phenothiazine and haloperidol families) which 1) the potential participant is not able/willing to stop taking for 1- week prior and for the 6-week duration of the study and/or 2) if removed could have a persistent effect beyond the 1-week wash-out period.
- Presence of insulin-dependent diabetes.
- History of mental retardation.
- Unable to communicate in English.
Key Trial Info
Start Date :
June 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04014387
Start Date
June 2 2019
End Date
June 30 2025
Last Update
October 23 2025
Active Locations (1)
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1
University of California- San Francisco
San Francisco, California, United States, 94158