MigraineNCT04575623
Auditory Functions in Patients With Migraine
An observational study of Migraine, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Migraine
- What is being tested?
- Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/ and 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.
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with migraine as study group and normal people as control group
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Central Auditory and Cognitive Functions in Patients Suffering From Migraine
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
Read the detailed description
The definition of central auditory processing CAP is based on auditory functions . Central auditory processing CAP involves a large number of skills which are highly dependent on a set integrity of the auditory pathways, from the outer ear to the auditory cortex. These skills include auditory selective attention, sound detection, and localization, discrimination of isolated and sequential sounds, as well as speech recognition, auditory comprehension and memory .
central auditory processing CAP is an indispensable tool for the investigation of the function of the central nervous system . The impairment of auditory processing could cause difficulties in complex listening situations, such as understanding speech in back-ground noise, rapid or degraded speech, and problems with comprehending verbal instructions.
Central auditory perception (CAP) can be assessed by Behavioral tests, which demonstrate good correlations with electrophysiological measures . Recording of event-related potentials (ERPs), because of its objectivity and noninvasive characteristics, presents one of the most useful tools in investigating neural substrates and cerebral regions involved in specific cognitive function. It implies recording of brain activity during a cognitive task .
Among the components of ERPs, theP300 is undoubtedly the most studied cerebral wave in evaluating cerebral information processing during the course of various neurological diseases because of its easy recording and reliability . The P300 develops if the subject is actively engaged in the task of detecting the targets.
Amplitude of the wave varies with the improbability of the targets and latency with the difficulty of discriminating the target stimulus from the standard stimuli . Typical peak latency P300 latency reflects timing of mental processes and the increase of latency represents prolongation of the processing time
- Conditions
- Migraine
- Being tested
- Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/, 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.
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 | Role | What they receive |
|---|---|---|
| Study group | It will consist of 120 patients suffering from migraine according to international classification of headache Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weaam Noaman Mohamed Aziz Aldin, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575623
- Sponsor's protocol ID
- Patients with migraine
- Status last verified
- Jan 2021
- First submitted
- 28 Sep 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Auditory and Cognitive Functions in Patients Suffering From Migraine
- ClinicalTrials.gov ID
- NCT04575623
- Acronym / sponsor ID
- Patients with migraine
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The definition of central auditory processing CAP is based on auditory functions . Central auditory processing CAP involves a large number of skills which are highly dependent on a set integrity of the auditory pathways, from the outer ear to the auditory cortex. These skills include auditory selective attention, sound detection, and localization, discrimination of isolated and sequential sounds, as well as speech recognition, auditory comprehension and memory .
central auditory processing CAP is an indispensable tool for the investigation of the function of the central nervous system . The impairment of auditory processing could cause difficulties in complex listening situations, such as understanding speech in back-ground noise, rapid or degraded speech, and problems with comprehending verbal instructions.
Central auditory perception (CAP) can be assessed by Behavioral tests, which demonstrate good correlations with electrophysiological measures . Recording of event-related potentials (ERPs), because of its objectivity and noninvasive characteristics, presents one of the most useful tools in investigating neural substrates and cerebral regions involved in specific cognitive function. It implies recording of brain activity during a cognitive task .
Among the components of ERPs, theP300 is undoubtedly the most studied cerebral wave in evaluating cerebral information processing during the course of various neurological diseases because of its easy recording and reliability . The P300 develops if the subject is actively engaged in the task of detecting the targets.
Amplitude of the wave varies with the improbability of the targets and latency with the difficulty of discriminating the target stimulus from the standard stimuli . Typical peak latency P300 latency reflects timing of mental processes and the increase of latency represents prolongation of the processing time
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | 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.It will consist of 120 patients suffering from migraine according to international classification of headache |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with migraine as study group and normal people as control group
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/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. | Diagnostic test | 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.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. | Device | Study group |
Primary outcome
Determination of central auditory processing in patients with migraine
Time frame: One year
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.
Determination of cognitive functions in patients with migraine
Time frame: One year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of central auditory processing in patients with migraine (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.