Overview
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.
Eligibility
Inclusion Criteria:
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 Criteria:
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.