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Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)

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ClinicalTrials.gov Identifier: NCT04014387
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE June 2, 2019
Estimated Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Sleep Efficiency [ Time Frame: average each of the 7 nights of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in sleep efficiency (as measured by actigraphy), this is a percentage of the time spent asleep compared to the total time in bed. The range of scores is 0-100, with higher scores associated with better sleep efficiency.
  • Clinical Global Impression [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in Clinical Global Impression (CGI-C), this is a series of questions for the participant and caregiver which the neurologist utilizes to give a score of disease affects across a series of domains, which produces a single change score referenced to the baseline Clinical Global Impression of Disease Severity (CGI-ds). The range of scores is 1-7, with lower scores associated with better health.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04014387 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Medication Satisfaction [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) ]
    Differences in satisfaction with the medication being taken. The Medication Satisfaction Scale is a study-specific customized satisfaction questionnaire of 3 questions each with a 5-point likert scale. The total range of scores is 3-15, with higher scores associated with greater medication satisfaction.
  • Adverse Events [ Time Frame: total of events across the 7 days/nights of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    The difference in the number of adverse events across each assessment week. The range of scores is 0 - undetermined, with greater scores associated with greater adverse events.
  • Alertness [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1) ]
    Change in alertness, which is assessed using question 8 of the Mayo Sleep Questionnaire - Informant. The range of scores is 0-10 with higher scores associated with greater alertness.
  • Sleepiness [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in sleepiness, which is assessed using the Epworth Sleepiness Scale. The range of scores is 0-24 with higher scores associated with increased sleepiness.
  • Insomnia [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in subjectively reported insomnia assessed using the Insomnia Severity Index. The range of scores is 0-28 with higher scores associated with increased levels of insomnia.
  • Anxiety [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in anxiety levels assessed using the Generalized Anxiety Disorder - 7 (GAD-7) scale. The range of scores is 0-21 with higher scores associated with greater anxiety.
  • Depression [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in depression assessed using the PHQ-9 scale. The range of scores is 0-27 with higher scores associated with greater depression.
  • Quality of Life [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in quality of life using the PSP Quality of life survey, which assesses subjective quality of life specifically in individuals with Progressive Supranuclear Palsy. The range of scores is 0-100 with higher scores associated with poorer quality of life.
  • Functionality [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in functionality is assessed using the Tau functional scale. This is a questionnaire, which both the patient and caregiver work together to complete. The total range of scores is 0-124 with subscores for "motor experiences of daily living" (0-48 points), "Language/cognitive/behavioral" concerns (0-52) and "Other non-motor experiences of daily living" (0-24). In all cases, greater scores are associated with decreased independent functionality in those domains.
  • Cognition [ Time Frame: 7th day of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1) ]
    Change in cognition will be assessed using working memory measures of digits forward and digits backward, and executive function measures of categorical fluency and verbal fluency. The range of scores for digits forward and digits backward is 0-16 each, with higher scores indicating better cognition. The likely range of scores for the fluency measures are 0-60 with higher scores associated with better executive function. Rule violations and repetitions are also counted and scored with greater scores in these domains associated with poorer cognition.
  • Slow wave sleep [ Time Frame: average of 5th-7th night of treatment for each of the two hypnotic drugs and placebo (weeks 2, 4 and 6) compared to baseline (week 1). ]
    Change in slow wave sleep will be assessed using a mobile EEG monitor called the Sleep Profiler (Advanced Brain Monitoring, Inc.). The amount of slow wave sleep will be measured as a percent of total sleep time, so the range of scores will be 0-100, with higher scores associated with greater amounts of slow wave sleep.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
Official Title  ICMJE Treatment of Disturbed Sleep in Progressive Supranuclear Palsy (PSP)
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Treatment
Intervention  ICMJE
  • Drug: Suvorexant
    Suvorexant (Belsomra) is an FDA approved, dual orexin receptor antagonist. It is prescribed for insomnia, reducing time to sleep onset, and to maintain nighttime sleep.
    Other Name: Belsomra
  • Drug: Zolpidem
    Zolpidem (Ambien) is an FDA approved, Benzodiazepine Receptor agonist that has been extensively studied for the treatment of insomnia in older adults. It acts as a sedative and is typically prescribed to treat insomnia, reducing time to sleep onset, but may not alter the ability to maintain sleep.
    Other Name: Ambien
  • Drug: Placebo oral capsule
    Placebo (microcrystalline cellulose) capsules will be used.
Study Arms  ICMJE
  • Active Comparator: Zolpidem Arm
    Participants will be given one week of Zolpidem.
    Intervention: Drug: Zolpidem
  • Active Comparator: Suvorexant Arm
    Participants will be given one week of Suvorexant.
    Intervention: Drug: Suvorexant
  • Placebo Comparator: Placebo Arm
    Participants will be given one week of a placebo pill.
    Intervention: Drug: Placebo oral capsule
Publications * Walsh CM, Ruoff L, Walker K, Emery A, Varbel J, Karageorgiou E, Luong PN, Mance I, Heuer HW, Boxer AL, Grinberg LT, Kramer JH, Miller BL, Neylan TC. Sleepless Night and Day, the Plight of Progressive Supranuclear Palsy. Sleep. 2017 Nov 1;40(11). doi: 10.1093/sleep/zsx154.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2021
Estimated Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, co-habitation 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:

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Neylan, MD 415-750-6961 Thomas.Neylan@ucsf.edu
Contact: Christine Walsh, PhD Christine.Walsh@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014387
Other Study ID Numbers  ICMJE 20181608
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE US Department of Veterans Affairs
Investigators  ICMJE
Principal Investigator: Thomas Neylan, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP