App-based Intervention for Treating Insomnia Among Patients With Epilepsy

NCT03683381 | Completed DMC

• 1 other identifier: IR.QUMS.REC.1397.698
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 4

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.

Conditions

Epilepsy; Insomnia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• Health related Quality of life

  changes from baseline, changes from baseline , 1 month and 6 Months follow-up

• Anxiety and Depression

  changes from baseline , changes from baseline , 1 month and 6 Months follow-up

Study Arms (2)

intervention

EXPERIMENTAL

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

Behavioral: Sleep Health

patient education

EXPERIMENTAL

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

Other: Patient education

Interventions

Sleep Health BEHAVIORAL

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

intervention

Patient education OTHER

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

patient education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presence of a rapidly progressing neurological or medical disorder
• a diagnosis of mental retardation
• use of drugs or alcohol
• Untreated sleep apnea
• Current pregnancy

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (4)

Booali Sina Hospital

Qazvin, 3419759811, Iran

Location

Shahid Rajaie Hospital

Qazvin, 3419759811, Iran

Location

Firoozgar Hospital

Tehran, Iran

Location

Mollasadra Neurology Clinic

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 32861897 DERIVED

MeSH Terms

Conditions

Epilepsy; Sleep Initiation and Maintenance Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: September 25, 2018
• Study Start: September 26, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IR (4)