Skip to main content
OpenTrials
Completed

NCT Number: NCT03683381

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Dyssomnias Insomnia Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Booali Sina Hospital, Qazvin, Iran

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Health

Behavioral

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

Patient Education

Other

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

Primary outcomes

  1. Insomnia symptoms

    Time frame: changes in ISI baseline , 1 month, 3 months and 6 months follow-up

    Isomnia symptom severity will be assessed using the Insomnia Severity Index

  2. sleep hygiene behavior

    Time frame: 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.

  3. objective sleep measure

    Time frame: 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.

Secondary outcomes

  1. Psychological predictors of sleep hygiene behavior (attitude, habit, self monitoring, self control, perceived behavior control

    Time frame: 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.

  2. Health related Quality of life

    Time frame: 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

  3. Anxiety and Depression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2018
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.