Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.
NCT ID: NCT03446066
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2015-01-12
2017-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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case group
20 cases suffering from excessive daytime sleepiness (4 females and 16 males) with their age range 32-58yrs and BMI range is 24.97-39.06 kg/m2
No interventions assigned to this group
control group
20 healthy subjects (5 females and 15 males) with their age range 31-55yrs and BMI range is 23.40-43.0 kg/m2
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
31 Years
58 Years
ALL
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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Leqaa El Mekkawy
assistant lecturer
Principal Investigators
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Mona Nada, prof.
Role: STUDY_DIRECTOR
Cairo University
Other Identifiers
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23101985
Identifier Type: -
Identifier Source: org_study_id
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