App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Not Applicable

Completed

• Conditions: Insomnia; Epilepsy
• Interventions: Behavioral: Sleep Health; Other: Patient education

• Registration Number: NCT03683381
• Lead Sponsor: Qazvin University Of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-10
• Study First Submitted QC: 2018-09-23
• Study First Posted: 2018-09-25
• Study Start: 2018-09-26
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Sleep Health	Patients in the intervention group will receive a 6-week app-based intervention to treat insomnia
patient education	Patient education	Participants in the patient education group will receive weekly information on insomnia symptoms

Primary Outcome Measures

Name	Time	Method
objective sleep measure	changes in objective sleep baseline , 1 month and 6 months follow-up	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.
sleep hygiene behavior	changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up	Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene.; behaviour.
Insomnia symptoms	changes in ISI baseline , 1 month, 3 months and 6 months follow-up	Isomnia symptom severity will be assessed using the Insomnia Severity Index

Secondary Outcome Measures

Name	Time	Method
Anxiety and Depression	changes from baseline , changes from baseline , 1 month and 6 Months follow-up	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.
Psychological predictors of sleep hygiene behavior (attitude, habit, self monitoring, self control, perceived behavior control	changes from baseline , changes from baseline , 1 month and 6 Months follow-up	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.
Health related Quality of life	changes from baseline, changes from baseline , 1 month and 6 Months follow-up	quality of Life in Epilepsy (QOLIE-31) will be used to assess quality of life

Trial Locations

Locations (4)

Firoozgar Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Booali Sina Hospital; 🇮🇷 Qazvin, Iran, Islamic Republic of

Shahid Rajaie Hospital; 🇮🇷 Qazvin, Iran, Islamic Republic of

Mollasadra Neurology Clinic; 🇮🇷 Tehran, Iran, Islamic Republic of