Skip to main content
OpenTrials
Completed

NCT Number: NCT03446066

Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

31 year–58 year

Sex eligibility

All sexes

Study type

Observational

About this study

*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:

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

    Time frame: 1 year

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

Secondary outcomes

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

    Time frame: 1year

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2018
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.