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NCT03632889 · ClinicalTrials.gov registry record · NA
A Computerized CBTi for Insomnia in Epilepsy
A NA study of Epilepsy and Insomnia, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03632889 is a NA study of Epilepsy and Insomnia that has completed, run by The Cleveland Clinic. The registered enrollment target is 50 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03632889, a NA study of Epilepsy and Insomnia, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study. The Investigators propose a pilot randomized, parallel-group, controlled trial comparing the GoToSleep program (GTS) and controls on change in Insomnia Severity Index (ISI) from baseline to week 8 in adults with epilepsy and moderate-to-severe insomnia. Adults with epilepsy and moderate-to-severe insomnia symptoms (ISI ≥15) 17 will be identified using data collected as part of routine clinical care in the adult epilepsy clinic. All subjects will be provided a consent form describing the study and provided sufficient information to make an informed decision. After a screening visit, subjects meeting study criteria will be randomized to the computerized cognitive behavioral therapy for insomnia (CCBT-i) using the GoTosleep (GTS) or the control group. Both groups will receive a sleep hygiene handout that is standard of care in the treatment of insomnia. All subjects will be contacted by phone every 2 weeks during the intervention to address questions related to sleep hygiene instructions and use of the CCBT-i in the GoTosleep (GTS) group. All subjects will complete a series of sleep related patient reported outcomes including the ISI at baseline 8 weeks post randomization and maintain a diary recording of seizures and sleep periods. Those randomized to CCBT-i will complete a questionnaire at week 8 assessing barriers to CCBT-i. Subjects randomized to the control group will be offered access to the GoTosleep (GTS) at no charge at the end of the study (week 8).
Interventions
- BEHAVIORAL GoToSleep Program
Study Locations (1)
Ohio
- Cleveland Clinic Main Campus - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03632889
The ClinicalTrials.gov registry entry for NCT03632889 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (95% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which GoToSleep Program is the first listed.
NCT03632889 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03632889 about?
NCT03632889 is a clinical study titled "A Computerized CBTi for Insomnia in Epilepsy". This is a pilot study. The Investigators propose a pilot randomized, parallel-group, controlled trial comparing the GoToSleep program (GTS) and controls on change in Insomnia Severity Index (ISI) from baseline to week 8 in adults with epilepsy and moderate-to-severe insomnia. Adults with epilepsy ...
What is the current status of trial NCT03632889?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2018-07-24. Estimated completion is 2022-12-31.
What conditions does trial NCT03632889 study?
This clinical trial studies the following conditions: Epilepsy, Insomnia.
What interventions are being tested in trial NCT03632889?
The interventions under investigation include: GoToSleep Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT03632889?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03632889 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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