Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05908526
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-05-11
Brief Title:
Insomnia Treatment and EMA ecological Momentary Assessment Outcomes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Impact of Suvorexant on Cognitive Function and Daytime Symptoms Among Community-dwelling Older Adults with Insomnia a Placebo-controlled Randomized Clinical Trial Using Remote Monitoring and Ecological Momentary Assessment
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to examine the impact of suvorexant an FDA-approved insomnia medication on daytime symptoms as measured by the Daytime Insomnia Symptoms Scale cognition positive mood negative mood and fatiguesleepiness among older adults with insomnia The primary hypothesis is that relative to placebo suvorexant will improve sleep and daytime symptoms The word placebo refers to a harmless pill with no therapeutic effect
Detailed Description:
The study will take about six to eight weeks to complete Participants will have a home sleep apnea test HSAT and complete a clinical interview Participants will also complete a baseline assessment which will take place over one or two days about 3 hours total
During the study participants will complete research questionnaires and cognitive testing at baseline and post-baseline after treatment Participants will also complete brief EMA surveys sleep diary and Daytime Insomnia Symptoms Scale via mobile device 4 times per day for approximately 16 days each survey will take about 2 minutes or less to complete Participants will also wear an actigraph on the non-dominant wrist This device looks like a wristwatch and measures ambulatory movement a validated proxy for sleep
During the study participants will complete research questionnaires and cognitive testing at baseline and post-baseline after treatment Participants will also complete brief EMA surveys sleep diary and Daytime Insomnia Symptoms Scale via mobile device 4 times per day for approximately 16 days each survey will take about 2 minutes or less to complete Participants will also wear an actigraph on the non-dominant wrist This device looks like a wristwatch and measures ambulatory movement a validated proxy for sleep
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None