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CompletedNCT03446066Updated Feb 26, 2018

Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

An observational study in Cognitive Impairment, sponsored by Kasr El Aini Hospital. Completed. Open to participants aged 31 Years to 58 Years. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Kasr El Aini Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
31 Years to 58 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Cognitive Impairment
03

Who can participate

Ages eligible
31 Years to 58 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

20 patients suffering from EDS 20 healthy subgects

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

05

What researchers measure

Primary outcomes

  1. change in Quantitative electroencephalography (QEEG) and P300 results from before to after single night sleep record in patients with excessive daytime sleepiness (EDS)

    the results of QEEG and P300 in patients with EDS before and after sleep

    Time frame: 1 year

Secondary outcomes

  1. potential integration of quantitative EEG and P300 as diagnostic tools for cognition and EDS.

    usage of electrophysiological tools for diagnosis of cognitive affection and sleepiness in EDS patients

    Time frame: 1year

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03446066
Lead sponsor
Kasr El Aini Hospital
Responsible party
Leqaa El Mekkawy (assistant lecturer, Kasr El Aini Hospital) — Principal investigator
First posted
Feb 26, 2018
Start date
Jan 12, 2015
Primary completion
Oct 1, 2017
Completion
Dec 23, 2017
Last update
Feb 26, 2018

Study contacts

Mona Nada, prof.
study director · Cairo University
View the source record on ClinicalTrials.gov ↗

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