App-based Intervention for Treating Insomnia Among Patients With Epilepsy

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Insomnia
• Intervention / Treatment: Behavioral: Sleep Health; Other: Patient education

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Booali Sina Hospital
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Shahid Rajaie Hospital
  • Tehran, Iran, Islamic Republic of
    • Firoozgar Hospital
  • Tehran, Iran, Islamic Republic of
    • Mollasadra Neurology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: September 23, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Epilepsy; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IR.QUMS.REC.1397.698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No