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Intervention Arm for Insomnia (MBSI-I Trial)
N/A
Waitlist Available
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post intervention
Awards & highlights
MBSI-I Trial Summary
This trial will test a new sleep intervention for people with mild cognitive impairment, which is a public health burden. The intervention is a brief, tablet-based, personalized, multicomponent behavioral sleep intervention. The findings of this study will inform future, larger scale clinical trials.
Eligible Conditions
- Insomnia
- Mild Cognitive Impairment
MBSI-I Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep latency
health related quality of life (HRQOL)
Secondary outcome measures
Self- reported insomnia symptoms
Sleep efficiency (SE)
Total sleep time (TST)
+2 moreOther outcome measures
Inflammatory Biomarkers including cytokines (IL-6, IL-1ß, TNF-α) and C-reactive protein (CRP)
MBSI-I Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Meaningful activity protocol during the day and Assisted Relaxation Therapy (ART) at night; includes 1) Sleep Hygiene Education; 2) Meaningful Activity Modules a) Physical Activity b) Cognitive Activity and c) Social engagement; 3) ART, a breath-based relaxation intervention that is coupled with a physical anchoring task. Participants will complete a daily sleep diary, use the activity modules daily as pre-determined times personalized to the participant, use the ART software when they get in bed to help with insomnia symptoms, and wear an actiwatch for a four-week period. Participants will have weekly to biweekly phone consultation with the research nurse.
Group II: Control ArmActive Control1 Intervention
Study participants in the control group will also receive a tablet and watch, but the meaningful activity modules and ART software will not be accessible to them. The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education. This approach provides staff and technology interaction/attention that is comparable to the intervention arm, and thereby promotes adherence; it has been used as a placebo comparator for many insomnia treatment studies and has low attrition rates. Control subjects will also be asked to complete electronic sleep diaries and wear the actiwatch on the non-dominant wrist to monitor sleep/wake patterns. For both arms, participants will be asked to complete baseline assessments, 4-week (post-intervention) and 12-week (follow-up).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multicomponent Behavioral Sleep Intervention for Insomnia
2021
N/A
~30
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,182 Total Patients Enrolled
15 Trials studying Insomnia
4,589 Patients Enrolled for Insomnia
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