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Computerized Group for Epilepsy

N/A

Waitlist Available

Led By Nancy Foldvary-Schaefer, DO

Research Sponsored by The Cleveland Clinic

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 8 weeks

Awards & highlights

Study Summary

This trial will test whether a computerized cognitive behavioral therapy for insomnia (CCBT-i) is more effective than a control group in reducing symptoms of insomnia in adults with epilepsy.

Eligible Conditions

Epilepsy
Insomnia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Aim - To compare change in Insomnia Severity Index (ISI) score from baseline to week 8 between Go! to sleep (GTS) and control in people with epilepsy and moderate-to-severe insomnia.

Secondary outcome measures

Epilepsy

Secondary Aim 10-To assess the relationship of change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) and adherence of Go! To sleep (GTS) program.

Secondary Aim 11-To describe participant barrier to use the on-line Go! To sleep program by using Barrier to Computerized Cognitive Behavioral Therapy for Insomnia (CCBT-i) questionnaire

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Computerized GroupExperimental Treatment1 Intervention

Subjects randomized to GoToSleep program will receive a sleep hygiene handout and a unique code for home access to the GoToSleep program.

Group II: Control ArmActive Control1 Intervention

Subjects randomized to the control group will receive a sleep hygiene handout .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GoToSleep Program

2018

N/A

~50

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Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,029 Previous Clinical Trials

1,365,028 Total Patients Enrolled

4 Trials studying Epilepsy

1,087 Patients Enrolled for Epilepsy

Nancy Foldvary-Schaefer, DOPrincipal Investigator - The Cleveland Clinic

Cleveland Clinic Hospital

Chicago College Of Osteopathic Medicine (Medical School)

Duke University Medical Center (Residency)

1 Previous Clinical Trials

59 Total Patients Enrolled

1 Trials studying Epilepsy

59 Patients Enrolled for Epilepsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals now able to enroll in this experiment?

"Affirmative. According to the latest updates posted on clinicaltrials.gov, this medical trial which was initially announced in July of 2018 is still seeking participants. 34 people need to be recruited from a single location for this study."

Answered by AI

To what extent is the participant pool for this clinical trial expanding?

"Correct. According to clincaltrials.gov, this medical trial was first posted on July 24th 2018 and is currently open for recruitment. The study intends to enroll 34 patients from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Computerized CBTi for Insomnia in Epilepsy

Nancy Foldvary-Schaefer 2018. "A Computerized CBTi for Insomnia in Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03632889.