App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2019-10-01

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.

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Detailed Description

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Conditions

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Epilepsy Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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intervention

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

Group Type EXPERIMENTAL

Sleep Health

Intervention Type BEHAVIORAL

Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep

patient education

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

Group Type EXPERIMENTAL

Patient education

Intervention Type OTHER

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

Interventions

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Sleep Health

Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep

Intervention Type BEHAVIORAL

Patient education

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No