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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | Patients in the intervention group will receive a 6-week app-based intervention to treat insomnia |
|
| patient education | Experimental | Participants in the patient education group will receive weekly information on insomnia symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Health | Behavioral | Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Booali Sina Hospital | Qazvin | 3419759811 | Iran | |||
| Shahid Rajaie Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32861897 | Derived | Ahorsu DK, Lin CY, Imani V, Carlbring P, Nygardh A, Brostrom A, Hamilton K, Pakpour AH. Testing an app-based intervention to improve insomnia in patients with epilepsy: A randomized controlled trial. Epilepsy Behav. 2020 Nov;112:107371. doi: 10.1016/j.yebeh.2020.107371. Epub 2020 Aug 27. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Patient education | Other | Participants in the Patient education group will receive weekly information on insomnia symptoms |
|
| 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 |
| Qazvin |
| 3419759811 |
| Iran |
| Firoozgar Hospital | Tehran | Iran |
| Mollasadra Neurology Clinic | Tehran | Iran |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |