App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Study Overview
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Brief Summary
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Sleep can affect frequency and occurrence of interictal spikes and occurrence, timing, and threshold of seizure. Epilepsy can worsen sleep architecture and severity of sleep disorders. Thus, a vicious cycle is set. Certain epilepsy syndromes are so intertwined with sleep that they are considered sleep-related epilepsies. Poor sleep in epilepsy is multifactorial and is worsened by poorly controlled seizures. App-delivered intervention has shown promise as a method to overcome health issues; however, the long-term effectiveness has not been proven in epileptic patients with chronic insomnia.

Official Title
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App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Conditions
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Epilepsy, Insomnia

Intervention / Treatment
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* Behavioral: Sleep Health
* Other: Patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are at least 18 years of age diagnosis of epilepsy according to the International League Against Epilepsy criteria Self-report moderate or severe insomnia as indicated by a score of 15 or higher on the Insomnia Severity Index Can speak, understand, and write in Persian No surgery planned in the next 6 months Have access to an Android smartphone or a desktop computer with Internet access absence of major cognitive impairment or active psychiatric disorders Exclusion Criteria: presence of a rapidly progressing neurological or medical disorder a diagnosis of mental retardation use of drugs or alcohol Untreated sleep apnea Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>Patients in the intervention group will receive a 6-week app-based intervention to treat insomnia | Behavioral: Sleep Health<br>* Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep<br>|
| Experimental: patient education<br>Participants in the patient education group will receive weekly information on insomnia symptoms | Other: Patient education<br>* Participants in the Patient education group will receive weekly information on insomnia symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia symptoms | Isomnia symptom severity will be assessed using the Insomnia Severity Index | changes in ISI baseline , 1 month, 3 months and 6 months follow-up | 
| sleep hygiene behavior | Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene. behaviour. | changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up | 
| objective sleep measure | Sleep data is measured by Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph will be worn by the patients for 7 consecutive days. | changes in objective sleep baseline , 1 month and 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological predictors of sleep hygiene behavior (attitude, habit, self monitoring, self control, perceived behavior control | psychological predictors of sleep hygiene behavior will be assessed using a using a self-reported measure. All items are rated on a Likert-type scale, ranging from 1 to 5. | changes from baseline , changes from baseline , 1 month and 6 Months follow-up | 
| Health related Quality of life | quality of Life in Epilepsy (QOLIE-31) will be used to assess quality of life | changes from baseline, changes from baseline , 1 month and 6 Months follow-up | 
| Anxiety and Depression | Zigmond and Snaith developed the 14-item HADS to measure the anxiety (7 items) and depression (7 items) of patients with both somatic and mental problems. The response descriptors of all items are Yes, definitely (score 3); Yes, sometimes (score 2); No, not much (score 1); No, not at all (score 0); except for items 7 and 10, which are scored reversely. A higher score represents higher levels of anxiety and depression: a domain score of 11 or greater indicates anxiety or depression; 8-10 indicates borderline case; 7 or lower indicates no signs of anxiety or depression. The two-factor framework of the HADS has been supported in epileptic patients. | changes from baseline , changes from baseline , 1 month and 6 Months follow-up |