Clinical trial NCT03446066: Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.
Official title: Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 31
Maximum age (years): 58
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients suffering from EDS 20 healthy subgects

Brief summary: Cognition was assessed using Minimental state examination (MMSE), Trail making tests A and B (TMT) tests, P300 and quantitative electroencephalography (QEEG) sleepiness was assessed using Epworth Sleepiness Scale (ESS), Karolinska sleepiness scale (KSS) and QEEG also polysomnography (PSG) was done for all participated subjects

Detailed description: \*The study is a case control study included 40 subjects, divided into 20 cases suffering from Excessive daytime sleepiness and 20 healthy control group.

all participants were subjected to:

1. Careful history taking and Complete neurological examination.
2. Initial assessment of cognition and sleepiness by two scales which were done once before sleep: Epworth Sleepiness Scale (ESS) and Minimental state examination (MMSE)
3. Scales and neurophysiological studies done before and after sleep:Karolinska sleepiness scale (KSS), Trail making tests A and B (TMT), P300, and QEEG
4. Polysomnography (PSG)

   * EEG was recorded for 20 minutes duration before and after sleep recording. In each EEG recording, alpha attenuation test (AAT) was done after 10 minutes of recording basal resting EEG, then the absolute power of 5 electrodes (CZ, T3, T4, T5, T6,) were studied in the following frequency bands: delta (0.5-3Hz), theta (4-7 Hz) and also the absolute power of (O1, O2) were studied in delta, theta and alpha (8-12 Hz) bands.

Eligibility criteria: Inclusion Criteria:

* The age ranges from 18 to 60 years. The age of all included subjects was 31-58 yrs old.
* The body mass index (BMI) range is 24.97-39.06 kg/m2 in patients and 23.40-43.0 kg/m2 in control group.
* Patients suffering from excessive daytime sleepiness symptoms according to the International Classification of Sleep Disorders definitions.

Exclusion Criteria:

* Patients suffering from EDS secondary to any sleep disorder other than sleep disordered breathing.
* Chronic debilitating disease as diabetes mellitus , hypertension or hyper- or hypo-thyroidism.
* Medications that could affect attention or vigilance as Benzodizipines, anti-psychotics or anti-epileptics.

Primary outcomes:
measure: change in Quantitative electroencephalography (QEEG) and P300 results from before to after single night sleep record in patients with excessive daytime sleepiness (EDS)
timeFrame: 1 year
Secondary outcomes:
measure: potential integration of quantitative EEG and P300 as diagnostic tools for cognition and EDS.
timeFrame: 1year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Mona Nada, prof.
role: STUDY_DIRECTOR
References: