Cognitive ImpairmentNCT03446066
Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.
An observational study of Cognitive Impairment, run by Kasr El Aini Hospital.
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… Read more about this study
- Who is it for?
- Ages 31 to 58 years
- Conditions the study is for
- Cognitive Impairment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2015to 23 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 to 58 years
- All sexes
- Adult
Study population: 20 patients suffering from EDS 20 healthy subgects
Who may be able to join
- 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.
Who cannot join
- 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.
About this 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
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:
- 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.
- Conditions
- Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start12 Jan 2015
- Primary completion1 Oct 2017
- Study completion23 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leqaa El Mekkawy, Kasr El Aini Hospital
- Investigators
- Mona Nada, prof., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446066
- Sponsor's protocol ID
- 23101985
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Assessment in Excessive Daytime Sleepiness: Electrophysiological Study.
- ClinicalTrials.gov ID
- NCT03446066
- Acronym / sponsor ID
- 23101985
- Conditions
- Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
*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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 31 to 58 years
- Sex
- All
- Age groups
- Adult
- Study population
- 20 patients suffering from EDS 20 healthy subgects
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
potential integration of quantitative EEG and P300 as diagnostic tools for cognition and EDS.
Time frame: 1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Nada, prof. study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by Kasr El Aini Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.