Skip to content

A Study to determine if improving sleep abnormalities can improve altered cognition among epilepsy patients.

Targeting specific sleep abnormalities in patients with different epilepsy syndromes, to improve their cognitive performance - a randomized controlled study - CESI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008359
Enrollment
152
Registered
2017-04-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Epilepsy

Interventions

Intervention1: Donepezil: 10 mg tablets in the morning. Oral for 6 months Intervention2: Zolpidem (sustained release): 6.25 mg tablets at bedtime. Oral for six months Control Intervention1: Placebo: O

Sponsors

Department of Health and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consequent patients diagnosed as TLE, FLE and JME by a single investigator (the PI), based on clinical, EEG, video-EEG and neuroimaging features, will be recruited as cases.

Exclusion criteria

Exclusion criteria: 1. if they have any additional epilepsy syndrome or if they cannot be classified into any of these categories; 2.if there is an established diagnosis of primary sleep disorders; 3.if there is a past history of prolonged status epilepticus which was followed by abrupt deterioration in sensorium and/or cognitive performance; 4.history of major traumatic brain injury, encephalitis or other neurological disorder with encephalopathy, after onset of epilepsy 5.if they suffer from cardiac arrhythmias or bronchial asthma or impaired renal or liver functions. 6.if they have severe mental subnormality (IQ

Design outcomes

Primary

MeasureTime frame
Cognitive performance. Quality of life.Timepoint: 6 Months

Secondary

MeasureTime frame
REM sleep percentage Slow wave sleep percentage. 50% or greater reduction in Seizure frequency Quality of sleep (Sleep efficiency) Change in daytime sleepiness (Epworth sleepiness scale) Timepoint: 6 Months

Countries

India

Contacts

Public ContactDr Garima Shukla

All India Institute of Medical Sciences, New Delhi

garimashukla@hotmail.com011-26593785

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026