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

Completed

• Conditions: Migraine
• Interventions: Device: Polysomnography

• Registration Number: NCT04413110
• Lead Sponsor: Mansoura University Hospital

Brief 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.

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 Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-04-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-05-30
• Last Update Submitted: 2020-05-30
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Polysomnography	Age and sex matched healthy controls
Subjective cognitive impaired	Polysomnography	Cases of migraine and subjective cognitive impaired

Primary Outcome Measures

Name	Time	Method
Polysomnography	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.

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt