SHUTi OASIS for Alzheimer Disease
Phase-Based Progress Estimates
Effectiveness
Safety
Alzheimer Disease+9 More
SHUTi OASIS - BehavioralEligibility
65+
All Sexes
What conditions do you have?
Select
Eligibility
65+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will study whether an internet-based cognitive behavioral therapy for insomnia can help improve sleep and cognition in people with mild cognitive impairment.
Eligible Conditions
- Alzheimer Disease
- Mild Cognitive Impairment (MCI)
- Insomnia
- Dyssomnias
- Cognitive Decline
- Sleep State Misperception
- Nervous System Diseases
- Sleeplessness
- Sleep Disorders
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Month 24
Blood coagulation tests
Falls frequency
Sleeplessness
Insomnia Severity Index
Lawson's Instrumental Activities of Daily Living Scale
Match to Sample Visual Search
Multidimensional Fatigue Symptoms Inventory - Short Form
Paired Associates Learning
Patient-Reported Outcomes Measurement Information System (PROMIS)
Sleeplessness
Short Form-12 Health Survey (Quality of Life)
Sleep Efficiency
Sleep Onset Latency
Spatial Working Memory Test
Wake after sleep onset (WASO)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
SHUTi OASIS
1 of 2
Patient Education Website
1 of 2
Experimental Treatment
Non-Treatment Group
144 Total Participants · 2 Treatment Groups
Primary Treatment: SHUTi OASIS · Has Placebo Group · Phase 2
SHUTi OASIS
Behavioral
Experimental Group · 1 Intervention: SHUTi OASIS · Intervention Types: BehavioralPatient Education Website
Other
PlaceboComparator Group · 1 Intervention: Patient Education · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
Who is running the clinical trial?
University of VirginiaLead Sponsor
679 Previous Clinical Trials
1,425,640 Total Patients Enrolled
5 Trials studying Alzheimer Disease
431 Patients Enrolled for Alzheimer Disease
Meghan K Mattos, PhD, RN, CNLPrincipal InvestigatorUniversity of Virginia
Eligibility Criteria
Age 65+ · All Participants · 9 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are willing to comply with all study procedures and are available for the duration of the study.
You are female or male, aged ≥ 65 years of age.
You must be willing to be emailed about the study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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