- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04413110
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
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.
Sponsor
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.
General Publications
- Bigal ME, Lipton RB, Tepper SJ, Rapoport AM, Sheftell FD. Primary chronic daily headache and its subtypes in adolescents and adults. Neurology. 2004 Sep 14;63(5):843-7. doi: 10.1212/01.wnl.0000137039.08724.18.
- Kavuk I, Yavuz A, Cetindere U, Agelink MW, Diener HC. Epidemiology of chronic daily headache. Eur J Med Res. 2003 Jun 30;8(6):236-40.
- Silberstein SD. Chronic daily headache. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):23S-29S.
- Bigal ME, Lipton RB. Modifiable risk factors for migraine progression. Headache. 2006 Oct;46(9):1334-43. doi: 10.1111/j.1526-4610.2006.00577.x.
- Bigal ME, Lipton RB. Obesity is a risk factor for transformed migraine but not chronic tension-type headache. Neurology. 2006 Jul 25;67(2):252-7. doi: 10.1212/01.wnl.0000225052.35019.f9.
- Esmael A, Abdelsalam M, Shoukri A, Elsherif M. Subjective cognitive impairment in patients with transformed migraine and the associated psychological and sleep disturbances. Sleep Breath. 2021 Dec;25(4):2119-2126. doi: 10.1007/s11325-021-02308-0. Epub 2021 Feb 4.
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
Additional Relevant MeSH Terms
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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