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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04413110
Other study ID # Mansoura University migraine
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date April 1, 2020

Study information

Verified date May 2020
Source Mansoura University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date April 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Polysomnography
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.

Locations

Country Name City State
Egypt Mansoura University Hospital Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Bigal ME, Lipton RB. Modifiable risk factors for migraine progression. Headache. 2006 Oct;46(9):1334-43. Review. — View Citation

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. — View Citation

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. — View Citation

Silberstein SD. Chronic daily headache. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):23S-29S. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Polysomnography 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
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