Clinical trial NCT04413110: PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine
Official title: PSG and Neuroendocrine Hormones in Subjective Cognitive Impaired Patients With Transformed Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: MIGRAINE
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Polysomnography
timeFrame: 24-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Silberstein SD. Chronic daily headache. J Am Osteopath Assoc. 2005 Apr;105(4 Suppl 2):23S-29S.
citation: 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.
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. doi: 10.1212/01.wnl.0000225052.35019.f9.
citation: 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.