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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413110
• Other study ID #: Mansoura University migraine
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

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