EpilepsyNCT03683381
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
A study testing Sleep Health and Patient education in people with Epilepsy and Insomnia, run by Qazvin University Of Medical Sciences at 4 sites in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Sleep Health and Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 4 sitesIran
- Study dates
- 26 Sep 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of a rapidly progressing neurological or medical disorder
- a diagnosis of mental retardation
- use of drugs or alcohol
- Untreated sleep apnea
- Current pregnancy
Trial locations and contacts
4 sites in 1 country.
Iran4 sites
Booali Sina Hospital
Qazvin, 3419759811
Shahid Rajaie Hospital
Qazvin, 3419759811
Firoozgar Hospital
Tehran
Mollasadra Neurology Clinic
Tehran
About this study
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.
- Being tested
- Sleep Health, Patient education
- Medical subject headings
- Epilepsy, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep HealthBehavioural
Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep
Patient educationOther
Participants in the Patient education group will receive weekly information on insomnia symptoms
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients in the intervention group will receive a 6-week app-based intervention to treat insomnia Receives: Behavioral: Sleep Health |
| patient education | Experimental | Participants in the patient education group will receive weekly information on insomnia symptoms Receives: Other: Patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia symptoms
Isomnia symptom severity will be assessed using the Insomnia Severity Index
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Health related Quality of life
quality of Life in Epilepsy (QOLIE-31) will be used to assess quality of life
Measured: changes from baseline, changes from baseline , 1 month and 6 Months follow-up
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.
Measured: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start26 Sep 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683381
- Sponsor's protocol ID
- IR.QUMS.REC.1397.698
- Status last verified
- Jan 2023
- First submitted
- 10 Aug 2018
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32861897
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-based Intervention for Treating Insomnia Among Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT03683381
- Acronym / sponsor ID
- IR.QUMS.REC.1397.698
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Sleep HealthPatients in the intervention group will receive a 6-week app-based intervention to treat insomnia |
| patient education | Experimental | Other: Patient educationParticipants in the patient education group will receive weekly information on insomnia symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- presence of a rapidly progressing neurological or medical disorder
- a diagnosis of mental retardation
- use of drugs or alcohol
- Untreated sleep apnea
- Current pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep HealthParticipants in the intervention group will be provided with an application containing weekly instructions to improve sleep | Behavioural | intervention |
| Patient educationParticipants in the Patient education group will receive weekly information on insomnia symptoms | Other | patient education |
Primary outcome
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
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.
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.
3 secondary outcomes
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
Health related Quality of life
Time frame: changes from baseline, changes from baseline , 1 month and 6 Months follow-up
Anxiety and Depression
Time frame: changes from baseline , changes from baseline , 1 month and 6 Months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Derived from this study: PubMed 32861897Ahorsu 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Health and Patient education in people with Epilepsy and Insomnia, run by Qazvin University Of Medical Sciences at 4 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia symptoms (time frame: changes in ISI baseline , 1 month, 3 months and 6 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.