Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

Cognitive Impairment Clinical Trial

Official title:

Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446066
• Other study ID #: 23101985
• Status: Completed
• Phase: N/A
• First received: January 28, 2018
• Last updated: February 19, 2018
• Start date: January 12, 2015
• Est. completion date: December 23, 2017

Study information

• Verified date: February 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 23, 2017
• Est. primary completion date: October 1, 2017
• Gender: All
• Age group: 31 Years to 58 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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	1year