PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine

May 30, 2020 updated by: Ahmed Esmael, Mansoura University Hospital
Transformed migraine is the most common and challenging subtype of chronic daily headache disorders35. Patients with transformed migraine often report an evolutionary process that occurs over months or years in which headaches increase in frequency, change characteristics and ultimately result in patterns of daily or near-daily headaches resembling a mixture of tension-type headache and migraine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study aimed to investigate the presence and frequency of cognitive affection in patients with transformed migraines, as well as to analyze the association of cognitive affection with clinical features and headache impact, anxiety, depression, and quality of sleep.

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The diagnosis of headache disorders was based on the International Classification of Disease, Eleventh Revision (ICD-11). Patients included were adults with clinically confirmed of chronic migraine, completion of cognitive testing and questionnaires, and normal performance on cognitive tests based on normative data, stratified by gender, age, and education level.

Description

Inclusion Criteria:

-Patients included were adults with clinically confirmed of chronic migraine

Exclusion Criteria:

  • Primary headache disorder other than migraine
  • Secondary headache disorders other than medication-overuse headache or unclassified headache, or
  • Aged under 18 years or older than 65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-subjective cognitive impaired
Cases of migraine and non-subjective cognitive impaired
Subjective cognitive impaired
Cases of migraine and subjective cognitive impaired
PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.
Control group
Age and sex matched healthy controls
PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography
Time Frame: 24-72 hours
PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.
24-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

May 30, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Mansoura University migraine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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