EpilepsyNCT06661759
Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
A study testing Clinic-based and technology-supported sleep intervention in people with Epilepsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents. Read more about this study
- Who is it for?
- Ages 18 months to 9 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Clinic-based and technology-supported sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
- Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.
Who cannot join
- Children who are bedridden.
- Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
- Children with severe motor dysfunction that prevents accurate sleep-wake differentiation via actigraphy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi-Shan Sung, +88623123456 ext. 288904, yshansung33@ntu.edu.tw
Shao-Yu Tsai, +88623123456 ext. 262962, stsai@ntu.edu.tw
About this study
Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.
Read the detailed description
Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.
- Conditions
- Epilepsy
- Being tested
- Clinic-based and technology-supported sleep intervention
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic-based and technology-supported sleep interventionBehavioural
CATS sleep intervention: The in-person sleep education and consultation will consist of 3 face-to-face, one-on-one sessions held 3 months apart during the child's routine clinic visit.The digital component of the sleep intervention will extend in-person education by providing ongoing support. Participants will receive one digital session per week for four weeks after the baseline, 3-month, and 6-month clinic visits, totaling 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention group | Experimental | standard pediatric neurology care plus a hybrid in-person and digital sleep education program Receives: Behavioral: Clinic-based and technology-supported sleep intervention |
| Usual care group | No intervention | standard pediatric neurology care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency by Actigraphy
Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist. Children's sleep will be objectively assessed for 7 days using actigraphy at each assessment time point. Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Secondary outcomes (8)
Sleep Onset Latency
Sleep onset latency is defined as the duration (minutes) from bedtime to actigraphy-derived sleep onset.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Wake After Sleep Onset (WASO)
WASO is defined as the duration (minutes) scored as wake between sleep onset and final awakening.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Total Nighttime Sleep
Total nighttime sleep by actigraphy is defined as the total duration scored as sleep within the nocturnal rest interval.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Daily 24-hour Sleep Duration
Daily 24-hour sleep duration is defined as the total duration scored as sleep.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Children's Sleep Habits Questionnaire (CSHQ)
The CSHQ is a 45-item parent-reported questionnaire used to assess sleep behaviors in children.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Child Behavior Checklist (CBCL)
CBCL is a parent-report instrument that evaluates behavioral and emotional problems in children.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is used to assess the overall sleep quality of parents, with higher scores indicating greater sleep disturbances.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Center for Epidemiologic Studies Depression Scale
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item questionnaire used to measure parents' symptoms of depression, with higher scores indicating more persistent symptoms.
Measured: At baseline and at 3, 6, and 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start19 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 National Taiwan University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shao-Yu Tsai, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661759
- Sponsor's protocol ID
- 202402064RINE
- Status last verified
- Nov 2025
- First submitted
- 24 Oct 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT06661759
- Acronym / sponsor ID
- 202402064RINE
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2024 (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.
Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.
Detailed description
Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention group | Experimental | Behavioral: Clinic-based and technology-supported sleep interventionstandard pediatric neurology care plus a hybrid in-person and digital sleep education program |
| Usual care group | No intervention | –standard pediatric neurology care |
Who may qualify
- Ages
- 18 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
- Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.
Key exclusion criteria (3 listed)
- Children who are bedridden.
- Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
- Children with severe motor dysfunction that prevents accurate sleep-wake differentiation via actigraphy.
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 |
|---|---|---|
| Clinic-based and technology-supported sleep interventionCATS sleep intervention: The in-person sleep education and consultation will consist of 3 face-to-face, one-on-one sessions held 3 months apart during the child's routine clinic visit.The digital component of the sleep intervention will extend in-person education by providing ongoing support. Participants will receive one digital session per week for four weeks after the baseline, 3-month, and 6-month clinic visits, totaling 12 sessions. | Behavioural | Experimental intervention group |
Primary outcome
Sleep Efficiency by Actigraphy
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist. Children's sleep will be objectively assessed for 7 days using actigraphy at each assessment time point. Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%.
8 secondary outcomes
Sleep Onset Latency
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Wake After Sleep Onset (WASO)
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Total Nighttime Sleep
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Daily 24-hour Sleep Duration
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Child Behavior Checklist (CBCL)
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Pittsburgh Sleep Quality Index
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Center for Epidemiologic Studies Depression Scale
Time frame: At baseline and at 3, 6, and 12 months after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Shao-Yu Tsai principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic-based and technology-supported sleep intervention in people with Epilepsy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-Shan Sung (+886223123456 ext. 288904, yshansung33@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency by Actigraphy (time frame: At baseline and at 3, 6, and 12 months after randomization.). 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 8 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.