Auditory Functions in Patients With Migraine

NCT04575623 | Unknown

• 1 other identifier: Patients with migraine
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Migraine is a neurological disease associated with an altered cortical excitability level . The prevalence of migraine is10.5% of adults in Assiut governorate, and is more frequent in women and in individuals with higher education level . There is evidence that migraine patients could present cognitive deficits, being the affected functions memory, processing information speed and attention. It was found that the prevalence of migraine in AlQuseir was 4.8/100 and the highest figures found during early adult life(18-40) years old .Patients with migraine found to perform significantly worse in duration pattern test(DPT),non-verbal dichotic test ,speech in noise (SPIN)test and found to have longer p300 frequency stimulus latency which indicate presence of cognitive and central auditory processing dysfunction

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Determination of central auditory processing in patients with migraine

  Evaluation of auditory functions in patients with migraine by using Duration Pattern test (DPT) designed to test temporal ordering abilities. Dichotic Digits Test (DDT) it assesses binaural integration skills. Auditory fusion test-revised (ART-R) to measure temporal resolution. speech in test to assess central auditory function.

  One year

• Determination of cognitive functions in patients with migraine

  Evaluation of cognitive functions in patients with migraine by Recording of event-related potentials (ERPs) by using odd ball paradigm auditoryP300 wave in evaluating cerebral information processing

  One year

Study Arms (1)

Study group

It will consist of 120 patients suffering from migraine according to international classification of headache

Diagnostic Test: Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/; Device: Dual band pure tone audiometer (Orbiter 992). -Impedance audiometer (AT 235h). -Sound treated booth (industrial acoustic company IAC model 1602-A-t) -Panasonic stereo CD player SA-AK 240.

Interventions

Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/ DIAGNOSTIC_TEST

Central auditory function evaluation including: * Duration Pattern test (DPT) designed to test temporal ordering abilities. * Dichotic Digits Test (DDT) it assesses binaural integration skills. * Auditory fusion test-revised (ART-R) to measure temporal resolution. * speech in test to assess central auditory function.

Study group

Dual band pure tone audiometer (Orbiter 992). -Impedance audiometer (AT 235h). -Sound treated booth (industrial acoustic company IAC model 1602-A-t) -Panasonic stereo CD player SA-AK 240. DEVICE

Cognitive function evaluation including: -Recording of event-related potentials (ERPs) by using odd ball paradigm auditoryP300 wave in evaluating cerebral information processing. Equipment: * Dual band pure tone audiometer (Orbiter 992). * Impedance audiometer (AT 235h). * Sound treated booth (industrial acoustic company IAC model 1602-A-t) * Panasonic stereo CD player SA-AK 240.

Study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with migraine as study group and normal people as control group

You may qualify if:

• It will consist of 100 patients suffering from migraine according to international classification of headache.
• Their age range from (18-40) years old which considered the most common affected age group ,
• Both sexes will be included.
• The study group will be further classified into two main categories migraine with and without aura.

You may not qualify if:

• Patients with history of systemic, neurologic or psychiatric illness.
• Patients with other types of headache.
• Patients with hearing loss.
• Patients with history of head trauma, surgery or ototoxic drug therapy

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 1, 2021

Record last verified: 2021-01