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

NCT04413110 | Completed

• 1 other identifier: Mansoura University migraine
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

MIGRAINE

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Non-subjective cognitive impaired

Cases of migraine and non-subjective cognitive impaired

Subjective cognitive impaired

Cases of migraine and subjective cognitive impaired

Device: Polysomnography

Control group

Age and sex matched healthy controls

Device: Polysomnography

Interventions

Polysomnography DEVICE

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; Subjective cognitive impaired

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients included were adults with clinically confirmed of chronic migraine

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (6)

• 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.

  PMID: 12911872 BACKGROUND

• 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.

  PMID: 15365134 BACKGROUND

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

  PMID: 15928350 BACKGROUND

• 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.

  PMID: 17040331 BACKGROUND

• 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.

  PMID: 16864817 BACKGROUND

• 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.

  PMID: 33543444 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Esmael M Ahmed, MD

  Assistant Prof of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Neurology

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 2, 2020
• Study Start: April 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)