NCT03446066

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 28, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

January 28, 2018

Last Update Submit

February 19, 2018

Conditions

Cognitive Impairment

Outcome Measures

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

    1 year

Secondary Outcomes (1)

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

    1year

Study Arms (2)

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

Eligibility Criteria

Age31 Years - 58 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 patients suffering from EDS 20 healthy subgects

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Mona Nada, prof.

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

January 28, 2018

First Posted

February 26, 2018

Study Start

January 12, 2015

Primary Completion

October 1, 2017

Study Completion

December 23, 2017

Last Updated

February 26, 2018

Record last verified: 2018-02