Clinical trial NCT03683381: App-based Intervention for Treating Insomnia Among Patients With Epilepsy
Official title: App-based Intervention for Treating Insomnia Among Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Insomnia
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia symptoms
timeFrame: changes in ISI baseline , 1 month, 3 months and 6 months follow-up
measure: sleep hygiene behavior
timeFrame: changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up
measure: objective sleep measure
timeFrame: changes in objective sleep baseline , 1 month and 6 months follow-up
Secondary outcomes:
measure: Psychological predictors of sleep hygiene behavior (attitude, habit, self monitoring, self control, perceived behavior control
timeFrame: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
measure: Health related Quality of life
timeFrame: changes from baseline, changes from baseline , 1 month and 6 Months follow-up
measure: Anxiety and Depression
timeFrame: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Booali Sina Hospital
city: Qazvin
country: Iran, Islamic Republic of
facility: Shahid Rajaie Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Firoozgar Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Mollasadra Neurology Clinic
Study officials:
References:
citation: 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.