App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Epilepsy Clinical Trial

Official title:

App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683381
• Other study ID #: IR.QUMS.REC.1397.698
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2023
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep Health
Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Booali Sina Hospital	Qazvin
Iran, Islamic Republic of	Shahid Rajaie Hospital	Qazvin
Iran, Islamic Republic of	Firoozgar Hospital	Tehran
Iran, Islamic Republic of	Mollasadra Neurology Clinic	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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