App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Qazvin University Of Medical Sciences

Status: Completed

Conditions: Epilepsy; Insomnia

Treatments: Behavioral: Sleep Health; Other: Patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT03683381

IR.QUMS.REC.1397.698

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups

intervention

Experimental group

Description:

Patients in the intervention group will receive a 6-week app-based intervention to treat insomnia

Treatment:

Behavioral: Sleep Health

patient education

Experimental group

Description:

Participants in the patient education group will receive weekly information on insomnia symptoms

Treatment:

Other: Patient education