EpilepsyNCT03632889
A Computerized CBTi for Insomnia in Epilepsy
A study testing GoToSleep Program in people with Epilepsy and Insomnia, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- GoToSleep Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Baseline ISI score ≥15
- Stable antiepileptic drug (AED) therapy for >30 days prior to enrollment without planned medication change, surgery or in-patient testing in the coming 90 days
- Able to quantify seizures
- Daily access to computer and internet
- Sufficient computer skills to engage in the on-line program
- Able to speak, read and understand English
Who cannot join
- Poorly quantified epileptic seizures, psychogenic non-epileptic seizures or other types of spells of undetermined etiology
- Cognitive impairment judged to be significant enough so as to impair one's ability to adhere to study procedures and sleep recommendations
- Major depression with suicidal ideations or presence of active co-morbid conditions that may affect study participation/completion
- Co-morbid sleep disorders that could be contributing to insomnia symptoms such as sleep apnea, restless legs syndrome (RLS) and circadian rhythm disorders
- Use of sedative-hypnotics, benzodiazepines, psychotropics, wake promoting agents and stimulants will be permitted provided the subject has been on a stable dose for at least 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Computerized Cognitive Behavioral Therapy (CBTi) Randomized, Controlled, Pilot Trial 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.
Read more
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).
Read the detailed description
Growing interest in the relationship between epilepsy and sleep has resulted in a number of investigations demonstrating the high prevalence of sleep disturbances and disorders in people with epilepsy (PWE). PWE frequently report daytime sleepiness, insomnia, and other sleep problems.
Insomnia is among the most common sleep complaint in PWE. The prevalence of moderate-to-severe insomnia using the ISI ranges from 15% to 51%. A recent case-control study found an association between insomnia symptom severity and poorer seizure control. Difficulty maintaining sleep is the most common insomnia presentation followed by difficulty initiating sleep. Both patterns are accompanied by a decrease in total sleep time and an increase in the number of awakenings, arousals and wake time after sleep onset, leading to a state of relative sleep deprivation. Like epilepsy, insomnia disorders are commonly associated with co-morbid depression in the general population, confirmed in a cohort of adults with epilepsy from our own epilepsy center. In turn, treatment of depression has been shown to improve insomnia in the general population. Further, improved seizure control has been observed following treatment of other comorbid sleep disorders such as obstructive sleep apnea and poor sleep hygiene. Innovative sleep treatments for PWE are needed.
To date, there are no studies exploring sleep and seizure outcomes with treatment of insomnia in PWE. Cognitive Behavioral Therapy for Insomnia(CBT-i) is generally the preferred initial treatment for most cases of primary insomnia. CBT-i examines and promotes modifications in thoughts and behaviors that perpetuate insomnia. The validity of CBT-i has been well established and the American College of Physicians has acknowledged CBT-i as the first-line therapy for insomnia with treatment effects that outlast those of sedative-hypnotic medications. Despite its established efficacy, CBT-i is not widely accessible due to the lack of trained clinicians, stigmatization in receiving psychological services, geographical remoteness to trained providers and cost. Treatment typically involves a series of up to 10 visits at weekly or biweekly intervals.
In recent years, CCBT-i programs have been developed that offer web-based treatment. One such program is GoTo sleep (GTS), developed and validated by investigators at the Cleveland Clinic. GTS constitutes 6 weeks of therapy based on the principles and methods of CBT-i presented as a series of daily lessons, learnable skills, and personalized recommendations supported by graphics, animations, audio and video. The program includes the basic elements of CBT-i including sleep hygiene, sleep restriction, stimulus control, cognitive restructuring and relaxation training. The efficacy of CCBT-i has been demonstrated in several randomized controlled trials involving patients with primary insomnia including one using GTS where the program was found to be superior to usual care (sleep hygiene instruction) after 6 weeks of therapy. Further, we recently conducted a pilot study comparing GTS and standard sleep hygiene instruction in Parkinson's disease patients with insomnia and found a greater reduction in ISI scores with CCBT-i (-7.9 vs -3.5; p=0.03).
Given the prevalence of insomnia in epilepsy and the known association between seizure occurrence and sleep impairment, the investigators hypothesize that treatment of insomnia with CCBT-i will improve insomnia symptoms and seizure control in PWE.
- Being tested
- GoToSleep Program
- Medical subject headings
- Epilepsy, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoToSleep ProgramBehavioural
For the control group only the sleep hygiene handout will be given in this arm. For the computerized group a sleep hygiene handout along with assess to the GoToSleep online program.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Subjects randomized to the control group will receive a sleep hygiene handout . |
| Computerized Group | Other | Subjects randomized to GoToSleep program will receive a sleep hygiene handout and a unique code for home access to the GoToSleep program. Receives: Behavioral: GoToSleep Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The number of participants with change in Insomnia Severity Index (ISI) score, total range score of 0-28, from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change in Insomnia Severity Index (ISI) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
Measured: baseline to 8 weeks
Secondary outcomes (16)
Secondary Aim 1 - To compare change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
The number of participants with change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) score (total score range of 0-21), from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
Measured: Baseline to 8 weeks
Secondary Aim 2 - To compare change in fatigue symptom on the Fatigue Severity Scale (FSS) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
The number of participants with change in fatigue symptom on the Fatigue Severity Scale (FSS) score, total range score of 9-63, from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change in fatigue symptom on the Fatigue Severity Scale (FSS) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
Measured: Baseline to 8 weeks
Secondary Aim 3 - To compare change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
The number of participants with change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) score, total range score of 0-24, from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
Measured: Baseline to 8 weeks
Secondary Aim 4 - To compare change in self-reported daily total sleep time (TST) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
The number of participants with change in self-reported daily total sleep time (TST) (average of minutes of total sleep time in one week ) from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change self-reported daily total sleep time (TST) (average of minutes of total sleep time in one week ) from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
Measured: Baseline to 8 weeks
Secondary Aim 5 - To compare change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
The number of participants with change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) score, total range score of 0-27, from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with depression symptom on the Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
Measured: Baseline to 8 weeks
Secondary Aim 6-To assess the relationship of change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) and adherence of Go! To sleep (GTS) program.
The relationship between change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) score (total score range of 0-21), and the number of the day of participation and total number of lessons completed in Go! To sleep program in people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program.
Measured: Baseline to 8 weeks
Secondary Aim 7-To assess the relationship of change in fatigue symptom on the Fatigue Severity Scale (FSS) and adherence of Go! To sleep (GTS) program.
The relationship between change in fatigue symptom on the Fatigue Severity Scale (FSS) score (total range score of 9-63), and the number of the day of participation and total number of lessons completed in Go! To sleep program in people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program.
Measured: Baseline to 8 weeks
Secondary Aim 8-To assess the relationship of change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) and adherence of Go! To sleep (GTS) program.
The relationship between change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) score (total range score of 0-24), and the number of the day of participation and total number of lessons completed in Go! To sleep program in people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program.
Measured: Baseline to 8 weeks
Secondary Aim 9-To assess the relationship of change in self-reported daily total sleep time (TST) (average of minutes of total sleep time in one week) and adherence of Go! To sleep (GTS) program
The relationship between change in self-reported daily total sleep time (TST) (average of minutes of total sleep time in one week) and the number of the day of participation and total number of lessons completed in Go! To sleep program in people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program.
Measured: Baseline to 8 weeks
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.
The relationship between change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) score (total range score of 0-27) and the number of the day of participation and total number of lessons completed in Go! To sleep program in people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program.
Measured: Baseline to 8 weeks
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
The people with epilepsy (PWE) and moderate-to-severe insomnia with Go! To sleep (GTS) program report barriers to use the on-line Go! To sleep (GTS) program by complete Barrier to Computerized Cognitive Behavioral Therapy for Insomnia (CCBT-i) questionnaire at week 8.
Measured: 8 weeks
Secondary Aim 12-To compare change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
The number of participants with change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI)(total score range of 0-21),in both people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program and without Go! To sleep (GTS) program compare to change in total daily seizure frequency (amount of focal and generalized seizure per day) from baseline to week 8.
Measured: Baseline to 8 weeks
Secondary Aim 13-To compare change in fatigue symptom on the Fatigue Severity Scale (FSS) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
The number of participants with change in fatigue symptom on the Fatigue Severity Scale (FSS) score (total range score of 9-63), in both people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program and without Go! To sleep (GTS) program compare to change in total daily seizure frequency (amount of focal and generalized seizure per day) from baseline to week 8.
Measured: Baseline to 8 weeks
Secondary Aim 14-To compare change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
The number of participants with change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) score, total range score of 0-24, in both people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program and without Go! To sleep (GTS) program compare to change in total daily seizure frequency (amount of focal and generalized seizure per day) from baseline to week 8.
Measured: Baseline to 8 weeks
Secondary Aim 15-To compare change in self-reported daily total sleep time (TST) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
The number of participants with change in self-reported daily total sleep time (TST) (average of minutes of total sleep time in one week ) in both people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program and without Go! To sleep (GTS) program compare to change in total daily seizure frequency (amount of focal and generalized seizure per day) from baseline to week 8.
Measured: Baseline to 8 weeks
Secondary Aim 16-To compare change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
The number of participants with change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) score, total range score of 0-27, in both people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program and without Go! To sleep (GTS) program compare to change in total daily seizure frequency (amount of focal and generalized seizure per day) from baseline to week 8.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start24 Jul 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Foldvary-Schaefer, The Cleveland Clinic
- Investigators
- Nancy Foldvary-Schaefer, DO, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632889
- Sponsor's protocol ID
- 18-242
- Status last verified
- Feb 2023
- First submitted
- 25 Jul 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computerized Cognitive Behavioral Therapy (CBTi) Randomized, Controlled, Pilot Trial for Insomnia in Epilepsy
- ClinicalTrials.gov ID
- NCT03632889
- Acronym / sponsor ID
- 18-242
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Growing interest in the relationship between epilepsy and sleep has resulted in a number of investigations demonstrating the high prevalence of sleep disturbances and disorders in people with epilepsy (PWE). PWE frequently report daytime sleepiness, insomnia, and other sleep problems.
Insomnia is among the most common sleep complaint in PWE. The prevalence of moderate-to-severe insomnia using the ISI ranges from 15% to 51%. A recent case-control study found an association between insomnia symptom severity and poorer seizure control. Difficulty maintaining sleep is the most common insomnia presentation followed by difficulty initiating sleep. Both patterns are accompanied by a decrease in total sleep time and an increase in the number of awakenings, arousals and wake time after sleep onset, leading to a state of relative sleep deprivation. Like epilepsy, insomnia disorders are commonly associated with co-morbid depression in the general population, confirmed in a cohort of adults with epilepsy from our own epilepsy center. In turn, treatment of depression has been shown to improve insomnia in the general population. Further, improved seizure control has been observed following treatment of other comorbid sleep disorders such as obstructive sleep apnea and poor sleep hygiene. Innovative sleep treatments for PWE are needed.
To date, there are no studies exploring sleep and seizure outcomes with treatment of insomnia in PWE. Cognitive Behavioral Therapy for Insomnia(CBT-i) is generally the preferred initial treatment for most cases of primary insomnia. CBT-i examines and promotes modifications in thoughts and behaviors that perpetuate insomnia. The validity of CBT-i has been well established and the American College of Physicians has acknowledged CBT-i as the first-line therapy for insomnia with treatment effects that outlast those of sedative-hypnotic medications. Despite its established efficacy, CBT-i is not widely accessible due to the lack of trained clinicians, stigmatization in receiving psychological services, geographical remoteness to trained providers and cost. Treatment typically involves a series of up to 10 visits at weekly or biweekly intervals.
In recent years, CCBT-i programs have been developed that offer web-based treatment. One such program is GoTo sleep (GTS), developed and validated by investigators at the Cleveland Clinic. GTS constitutes 6 weeks of therapy based on the principles and methods of CBT-i presented as a series of daily lessons, learnable skills, and personalized recommendations supported by graphics, animations, audio and video. The program includes the basic elements of CBT-i including sleep hygiene, sleep restriction, stimulus control, cognitive restructuring and relaxation training. The efficacy of CCBT-i has been demonstrated in several randomized controlled trials involving patients with primary insomnia including one using GTS where the program was found to be superior to usual care (sleep hygiene instruction) after 6 weeks of therapy. Further, we recently conducted a pilot study comparing GTS and standard sleep hygiene instruction in Parkinson's disease patients with insomnia and found a greater reduction in ISI scores with CCBT-i (-7.9 vs -3.5; p=0.03).
Given the prevalence of insomnia in epilepsy and the known association between seizure occurrence and sleep impairment, the investigators hypothesize that treatment of insomnia with CCBT-i will improve insomnia symptoms and seizure control in PWE.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Subjects randomized to the control group will receive a sleep hygiene handout . |
| Computerized Group | Other | Behavioral: GoToSleep ProgramSubjects randomized to GoToSleep program will receive a sleep hygiene handout and a unique code for home access to the GoToSleep program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Baseline ISI score ≥15
- Stable antiepileptic drug (AED) therapy for >30 days prior to enrollment without planned medication change, surgery or in-patient testing in the coming 90 days
- Able to quantify seizures
- Daily access to computer and internet
Key exclusion criteria (5 listed)
- Poorly quantified epileptic seizures, psychogenic non-epileptic seizures or other types of spells of undetermined etiology
- Cognitive impairment judged to be significant enough so as to impair one's ability to adhere to study procedures and sleep recommendations
- Major depression with suicidal ideations or presence of active co-morbid conditions that may affect study participation/completion
- Co-morbid sleep disorders that could be contributing to insomnia symptoms such as sleep apnea, restless legs syndrome (RLS) and circadian rhythm disorders
- Use of sedative-hypnotics, benzodiazepines, psychotropics, wake promoting agents and stimulants will be permitted provided the subject has been on a stable dose for at least 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GoToSleep ProgramFor the control group only the sleep hygiene handout will be given in this arm. For the computerized group a sleep hygiene handout along with assess to the GoToSleep online program. | Behavioural | Computerized Group |
Primary outcome
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.
Time frame: baseline to 8 weeks
The number of participants with change in Insomnia Severity Index (ISI) score, total range score of 0-28, from baseline to week 8 in people with epilepsy (PWE)and moderate-to-severe insomnia with Go! To sleep (GTS) program compare to the number of participants with change in Insomnia Severity Index (ISI) score from baseline to week 8 in people with epilepsy (PWE) and moderate-to-severe insomnia without Go! To sleep (GTS) program
16 secondary outcomes
Secondary Aim 1 - To compare change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 2 - To compare change in fatigue symptom on the Fatigue Severity Scale (FSS) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 3 - To compare change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 4 - To compare change in self-reported daily total sleep time (TST) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 5 - To compare change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) from baseline to week 8 between Go! To sleep (GTS) and controls in people with epilepsy and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 6-To assess the relationship of change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) and adherence of Go! To sleep (GTS) program.
Time frame: Baseline to 8 weeks
Secondary Aim 7-To assess the relationship of change in fatigue symptom on the Fatigue Severity Scale (FSS) and adherence of Go! To sleep (GTS) program.
Time frame: Baseline to 8 weeks
Secondary Aim 8-To assess the relationship of change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) and adherence of Go! To sleep (GTS) program.
Time frame: Baseline to 8 weeks
Secondary Aim 9-To assess the relationship of change in self-reported daily total sleep time (TST) (average of minutes of total sleep time in one week) and adherence of Go! To sleep (GTS) program
Time frame: Baseline to 8 weeks
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.
Time frame: Baseline to 8 weeks
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
Time frame: 8 weeks
Secondary Aim 12-To compare change in sleep quality on the Pittsburgh Sleep Quality Inventory (PSQI) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 13-To compare change in fatigue symptom on the Fatigue Severity Scale (FSS) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 14-To compare change in daytime sleepiness symptom on the Epworth Sleepiness Scale (ESS) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 15-To compare change in self-reported daily total sleep time (TST) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Secondary Aim 16-To compare change in depression symptom on the Patient Health Questionnaire-9 (PHQ-9) and mean daily seizure frequency from baseline to week 8 between GTS and controls in PWE and moderate-to-severe insomnia symptoms.
Time frame: Baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
Enrolling by invitation
An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Enrolling by invitationObservational study
Neurophysiological Intraoperative or Epilepsy Monitoring
Patients Operated on at the Neurosurgery Department
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Foldvary-Schaefer, DO principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GoToSleep Program in people with Epilepsy and Insomnia, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.