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App-based Intervention for Treating Insomnia Among Patients With Epilepsy

Primary Purpose

Epilepsy, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Sleep Health
Patient education
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Booali Sina Hospital
  • Shahid Rajaie Hospital
  • Firoozgar Hospital
  • Mollasadra Neurology Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intervention

patient education

Arm Description

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

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

Outcomes

Primary Outcome Measures

Insomnia symptoms
Isomnia symptom severity will be assessed using the Insomnia Severity Index
sleep hygiene behavior
Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene. behaviour.
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.

Secondary Outcome Measures

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.
Health related Quality of life
quality of Life in Epilepsy (QOLIE-31) will be used to assess quality of life
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.

Full Information

First Posted
August 10, 2018
Last Updated
January 11, 2023
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03683381
Brief Title
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
Official Title
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive a 6-week app-based intervention to treat insomnia
Arm Title
patient education
Arm Type
Experimental
Arm Description
Participants in the patient education group will receive weekly information on insomnia symptoms
Intervention Type
Behavioral
Intervention Name(s)
Sleep Health
Intervention Description
Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep
Intervention Type
Other
Intervention Name(s)
Patient education
Intervention Description
Participants in the Patient education group will receive weekly information on insomnia symptoms
Primary Outcome Measure Information:
Title
Insomnia symptoms
Description
Isomnia symptom severity will be assessed using the Insomnia Severity Index
Time Frame
changes in ISI baseline , 1 month, 3 months and 6 months follow-up
Title
sleep hygiene behavior
Description
Sleep hygiene behaviour will use three items to measure how many days the participants had good sleep hygiene. behaviour.
Time Frame
changes in sleep hygiene behavior baseline , 1 month, 3 months and 6 months follow-up
Title
objective sleep measure
Description
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.
Time Frame
changes in objective sleep baseline , 1 month and 6 months follow-up
Secondary Outcome Measure Information:
Title
Psychological predictors of sleep hygiene behavior (attitude, habit, self monitoring, self control, perceived behavior control
Description
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.
Time Frame
changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Title
Health related Quality of life
Description
quality of Life in Epilepsy (QOLIE-31) will be used to assess quality of life
Time Frame
changes from baseline, changes from baseline , 1 month and 6 Months follow-up
Title
Anxiety and Depression
Description
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.
Time Frame
changes from baseline , changes from baseline , 1 month and 6 Months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Booali Sina Hospital
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Facility Name
Shahid Rajaie Hospital
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Facility Name
Firoozgar Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
Mollasadra Neurology Clinic
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
32861897
Citation
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.
Results Reference
derived

Learn more about this trial

App-based Intervention for Treating Insomnia Among Patients With Epilepsy

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