Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

NCT ID: NCT03446066

Last Updated: 2018-02-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-12

Study Completion Date

2017-12-23

Brief Summary

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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

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\*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.

Conditions

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Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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 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.
Minimum Eligible Age

31 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Leqaa El Mekkawy

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

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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