HypothyroidismNCT05334771
Early Detection of Endolymphatic Hydrops in Hypothyroid Patients
An observational study of Hypothyroidism, run by Assiut University.
Trial summary
Early detection of endolymphatic hydrops in hypothyroid patients Study outcome of medical treatment for hypothyroid patients Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Dual band pure tune audiometer
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Apr 2025
- 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 25 to 50 years
- All sexes
- Adult
Study population: Study group will include 50 patients, their ages from 20 to 50 years old described with hypothyroidism. 50 patients will be divided in to 2 groups: 1-25 patients controlled on medical treatment. 2-25 patients uncontrolled on medical treatment.
Who may be able to join
- their age range from (25-50) years old .
- Both sexes will be included.
- Total coverage of patients attending the clinic in the fixed chosen day weekly suffering from Hypothyroidism patients with vertigo clinical diagnosis of Alzheimer's disease
Who cannot join
- evidence of systemic illness except thyroid hypo function evidence of other autoimmune diseases history of head trauma neck stiffness conductive hearing loss insulin dependent diabetes
- .
Trial locations and contacts
No sites are listed yet.
About this study
Early detection of endolymphatic hydrops in hypothyroid patients Study outcome of medical treatment for hypothyroid patients
Read the detailed description
Endolymphatic hydrops is acommon inner ear dysfunction. This term often used with meniere's disease and meniere's syndrome. However meniere's is idiopathic by definition where as it can occur secondary to various processes interfering with normal production or absorption of endolymph. Histopathologically, endolymphatic hydrops is seen initially in the cochlear duct and the saccule; with the progression of the disease, subsequent affection of the utricle and semicircular canals (SCC) occur . Vascular alterations, genetic predisposition, hormonal disorders and nutritional and psychological factors might contribute to the genesis of hydrops . Serum antibodies against internal ear antigens and circulating immunocomplexes as well as apositive response to steroid treatment have been reported. Furthermore, MD patients present some features of immune diseases, such as hereditary predisposition, apositive family history for the disease and hypothetic association with certain human leucocyte antigen loci (Cw7, A1, B8) .
The thyroid gland has crucial functions to regulate the endocrine systems through the hypothalamic-pituitarythyroid axis and affect organ-specific such as as Addison's disease and type 1 diabetes mellitus or non-organ-specific such as rheumatoid arthritis and systemic lupus erythematosus .
Ménière's disease is clinically diagnosed by recurrent vertigo attacks combined with cochlear symptoms of primarily low- or mid-frequency sensorineural hearing loss, tinnitus, or ear fullness . The incidence of Ménière's disease varies according to the ethnic population, which is estimated to be about 13-200 person-years . The peak age of onset of Ménière's disease has been reported to be about 40-60 years . The sudden surge of endolymphatic flow, which shifts from the pars inferior (cochlea) to the pars superior (utricle and semicircular canals), stimulates the vestibular hair cells in the cristae of the semicircular canals and may induce vertigo attack in patients with Ménière's disease. However, the pathophysiologic causes for the increase of endolymphatic flow are not understood and are thought to be multifactorial, including abnormal immune response and metabolic endocrine dysfunctions, such as hypothyroidism. Previous studies have suggested the association of hypothyroidism with Ménière's disease . Many studies reported high incidence of thyroid dysfunction in Ménière's disease.
The possible association between (autoimmune) thyroid disease and MD has been postulated for more than 30 years, but it is still controversial. Pulec and House first reported that 3% of patients with MD had a positive history for hyperthyroidism, and Powers et al. found a much higher prevalence of association between MD and hypothyroidism. However, at the beginning of the 1980s, arelationship between altered thyroid function and MD was actually excluded by Kinney and by Meyerhoff et al. , while Evans et al. showed subsequently that 17% of sera from MD patients contained positive anti-thyroidmicrosome antibody titres.
The assessment of patients with Ménière's disease can be challenging. VEMP findings in Meniere's patients varies based on the acuteness and stage of the disease. ~50% of patients with Meniere's disease have asymmetric CVEMP responses, indicating differences in the saccular function (returns to normal in ~50%). Recent reports show different frequency tuning in CVEMP thresholds for 250 Hz - 1 kHz stimuli in patients with endolymphatic hydrops. Some patients show the same pattern in the unaffected ear, perhaps indicating delayed endolymphatic hydrops. 40% of Meniere's patients show improvement in cVEMP amplitude following the administration of furosemide (Seo et al, 2003).
VEMP is aneurophysiological assisment technique to evaluate the patient vestibular function It could be useful in the analysis of saccular and vestibulospinal tract function, detecting pathologies in inferior vestibular nerve and diagnosis of meniere's disease.saccular afferents stimulate VEMP response and this disease in early stages,affects saccular function, so this is clear that the altered saccule has different function and will cause changes in VEMP test results
- Conditions
- Hypothyroidism
- Being tested
- Dual band pure tune audiometer
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual band pure tune audiometerDevice
Also called Impedance audiometry
Orbiter 922 Tympanometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Early detection of endolymphtic hydrops in hypothyroid patients
Cervical vestibular evoked myogenic potential
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startSep 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothyroidismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ali Abdelazeem Mohamed, Assiut University
- Investigators
- Enas Mostafa Osman, lecturer, Study chair, audiovestibular medicine, assiut universitymohamed salama bakr, professor, Study director, audiovestibular medicine, assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334771
- Sponsor's protocol ID
- Hypothyroidism
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. Elmoazen DM, Sobhy OA, Abd Elbaky F. Vestibular evoked myogenic potentials and video head impulse tests in different stages of Meniere's disease. Advanced Arab Academy of Audio-Vestibulogy Journal. 2015;2(2):45. 2. Baloh R, Honrubia V. Endolymphatic hydrops (Meniere's syndrome). Clinical neurophysiology of the vestibular system, 3rd ed. New York: Oxford …; 2001. 3. Friedman RA, Ryan AF. The molecular mechanism and genetics of Meniere disease. Meniere's disease: Kugler Pubblications The Hague; 1999. p. 356-69. 4. Yoo T, Ge X, Sener O, Mora M, Kwon SS, Mora F, et al. Presence of autoantibodies in the sera of Meniere's disease. Annals of Otology, Rhinology & Laryngology. 2001;110(5):425-9. 5. Fisher LM, Derebery MJ, Friedman RA. Oral steroid treatment for hearing improvement in Ménière's disease and endolymphatic hydrops. Otology & Neurotology. 2012;33(9):1685-91. 6. Hsu L, Zhu X-N, Zhao Y-S. Immunoglobulin E and circulating immune complexes in endolymphatic hydrops. Annals of Otology, Rhinology & Laryngology. 1990;99(7):535-8. 7. Garcia-Purrinos F, Ferri E, Rosell A, Calvo J. Combined intratympanic and intravenous dexomethasone to control vertigo in Meniere disease. Acta otorrinolaringologica espanola. 2005;56(2):74-7. 8. Shea JJ. Autoimmune sensorineural hearing loss as an aggravating factor in Meniere's disease. Neurophysiological and Clinical Aspects of Vestibular Disorders. 30: Karger Publishers; 1983. p. 254-7. 9. Xenellis J, Morrison A, McClowskey D, Festenstein H. HLA antigens in the pathogenesis of Meniere's disease. The Journal of Laryngology & Otology. 1986;100(1):21-4. 10. Duntas LH, Mantzou E, Koutras DA. Circulating levels of oxidized low-density lipoprotein in overt and mild hypothyroidism. Thyroid. 2002;12(11):1003-7. 11. Goebel JA. 2015 Equilibrium Committee amendment to the 1995 AAO-HNS guidelines for the definition of Meniere's disease. Otolaryngology--Head and Neck Surgery. 2016;154(3):403-4. 12. Kim C-H, Shin JE, Yoo MH, Park HJ. Direction-changing and direction-fixed positional nystagmus in patients with vestibular neuritis and meniere disease. Clinical and Experimental Otorhinolaryngology. 2019;12(3):255. 13. Alexander TH, Harris JP. Current epidemiology of Meniere's syndrome. Otolaryngologic Clinics of North America. 2010;43(5):965-70. 14. Shambaugh Jr GE. Endocrine aspects of meniere's disease. The Laryngoscope. 1959;69(8):1027-32. 15. Powers WH. Metabolic aspects of Meniere's disease. The Laryngoscope. 1978;88(1):122-9. 16. Kinney SE. The metabolic evaluation in Meniere's disease. Otolaryngology-Head and Neck Surgery. 1980;88(5):594-8. 17. Meyerhoff WL, Paparella MM, Gudbrandsson FK. Clinical evaluation of Meniere's disease. The Laryngoscope. 1981;91(10):1663-8. 18. Evans K, Baldwin D, Bainbridge D, Morrison A. Immune status in patients with Meniere's disease. Archives of oto-rhino-laryngology. 1988;245(5):287-92. 19. Seo T, Node M, Yukimasa A, Sakagami M. Furosemide loading vestibular evoked myogenic potential for unilateral Ménière's disease. Otology & neurotology. 2003;24(2):283-8. 20. Colebatch J, Halmagyi G. Vestibular evoked potentials in human neck muscles before and after unilateral vestibular deafferentation. Neurology. 1992;42(8):1635-. 21. Halmagyi G, Colebatch J, Curthoys I. New tests of vestibular function. Bailliere's clinical neurology. 1994;3(3):485-500. 22. Jacobson G. mccaslin DL. The Vestibular-Evoked Myogenic Potential and Other Sonomotor Evoked Potentials. Auditory Evoked Potentials Basic Principles and Clinical Application. USA Lippincott Williams & Wilkins. 2007;8(27):572-98. 23. Jacobson G, McCaslin D. The vestibular evoked myogenic potential and other sonomotor evoked potentials. Lippincott Williams & Wilkins Baltimore, Md, USA; 2007. p. 572-98.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Endolymphatic Hydrops in Hypothyroid Patients
- ClinicalTrials.gov ID
- NCT05334771
- Acronym / sponsor ID
- Hypothyroidism
- Conditions
- Hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Apr 2022 (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.
Early detection of endolymphatic hydrops in hypothyroid patients Study outcome of medical treatment for hypothyroid patients
Detailed description
Endolymphatic hydrops is acommon inner ear dysfunction. This term often used with meniere's disease and meniere's syndrome. However meniere's is idiopathic by definition where as it can occur secondary to various processes interfering with normal production or absorption of endolymph. Histopathologically, endolymphatic hydrops is seen initially in the cochlear duct and the saccule; with the progression of the disease, subsequent affection of the utricle and semicircular canals (SCC) occur . Vascular alterations, genetic predisposition, hormonal disorders and nutritional and psychological factors might contribute to the genesis of hydrops . Serum antibodies against internal ear antigens and circulating immunocomplexes as well as apositive response to steroid treatment have been reported. Furthermore, MD patients present some features of immune diseases, such as hereditary predisposition, apositive family history for the disease and hypothetic association with certain human leucocyte antigen loci (Cw7, A1, B8) .
The thyroid gland has crucial functions to regulate the endocrine systems through the hypothalamic-pituitarythyroid axis and affect organ-specific such as as Addison's disease and type 1 diabetes mellitus or non-organ-specific such as rheumatoid arthritis and systemic lupus erythematosus .
Ménière's disease is clinically diagnosed by recurrent vertigo attacks combined with cochlear symptoms of primarily low- or mid-frequency sensorineural hearing loss, tinnitus, or ear fullness . The incidence of Ménière's disease varies according to the ethnic population, which is estimated to be about 13-200 person-years . The peak age of onset of Ménière's disease has been reported to be about 40-60 years . The sudden surge of endolymphatic flow, which shifts from the pars inferior (cochlea) to the pars superior (utricle and semicircular canals), stimulates the vestibular hair cells in the cristae of the semicircular canals and may induce vertigo attack in patients with Ménière's disease. However, the pathophysiologic causes for the increase of endolymphatic flow are not understood and are thought to be multifactorial, including abnormal immune response and metabolic endocrine dysfunctions, such as hypothyroidism. Previous studies have suggested the association of hypothyroidism with Ménière's disease . Many studies reported high incidence of thyroid dysfunction in Ménière's disease.
The possible association between (autoimmune) thyroid disease and MD has been postulated for more than 30 years, but it is still controversial. Pulec and House first reported that 3% of patients with MD had a positive history for hyperthyroidism, and Powers et al. found a much higher prevalence of association between MD and hypothyroidism. However, at the beginning of the 1980s, arelationship between altered thyroid function and MD was actually excluded by Kinney and by Meyerhoff et al. , while Evans et al. showed subsequently that 17% of sera from MD patients contained positive anti-thyroidmicrosome antibody titres.
The assessment of patients with Ménière's disease can be challenging. VEMP findings in Meniere's patients varies based on the acuteness and stage of the disease. ~50% of patients with Meniere's disease have asymmetric CVEMP responses, indicating differences in the saccular function (returns to normal in ~50%). Recent reports show different frequency tuning in CVEMP thresholds for 250 Hz - 1 kHz stimuli in patients with endolymphatic hydrops. Some patients show the same pattern in the unaffected ear, perhaps indicating delayed endolymphatic hydrops. 40% of Meniere's patients show improvement in cVEMP amplitude following the administration of furosemide (Seo et al, 2003).
VEMP is aneurophysiological assisment technique to evaluate the patient vestibular function It could be useful in the analysis of saccular and vestibulospinal tract function, detecting pathologies in inferior vestibular nerve and diagnosis of meniere's disease.saccular afferents stimulate VEMP response and this disease in early stages,affects saccular function, so this is clear that the altered saccule has different function and will cause changes in VEMP test results
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Study group will include 50 patients, their ages from 20 to 50 years old described with hypothyroidism. 50 patients will be divided in to 2 groups: 1-25 patients controlled on medical treatment. 2-25 patients uncontrolled on medical treatment.
Key inclusion criteria (3 listed)
- their age range from (25-50) years old .
- Both sexes will be included.
- Total coverage of patients attending the clinic in the fixed chosen day weekly suffering from Hypothyroidism patients with vertigo clinical diagnosis of Alzheimer's disease
Key exclusion criteria (2 listed)
- evidence of systemic illness except thyroid hypo function evidence of other autoimmune diseases history of head trauma neck stiffness conductive hearing loss insulin dependent diabetes
- .
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 |
|---|---|---|
| Dual band pure tune audiometerAlso: Impedance audiometryOrbiter 922 Tympanometry | Device | – |
Primary outcome
Early detection of endolymphtic hydrops in hypothyroid patients
Time frame: Baseline
Cervical vestibular evoked myogenic potential
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background1. Elmoazen DM, Sobhy OA, Abd Elbaky F. Vestibular evoked myogenic potentials and video head impulse tests in different stages of Meniere's disease. Advanced Arab Academy of Audio-Vestibulogy Journal. 2015;2(2):45. 2. Baloh R, Honrubia V. Endolymphatic hydrops (Meniere's syndrome). Clinical neurophysiology of the vestibular system, 3rd ed. New York: Oxford …; 2001. 3. Friedman RA, Ryan AF. The molecular mechanism and genetics of Meniere disease. Meniere's disease: Kugler Pubblications The Hague; 1999. p. 356-69. 4. Yoo T, Ge X, Sener O, Mora M, Kwon SS, Mora F, et al. Presence of autoantibodies in the sera of Meniere's disease. Annals of Otology, Rhinology & Laryngology. 2001;110(5):425-9. 5. Fisher LM, Derebery MJ, Friedman RA. Oral steroid treatment for hearing improvement in Ménière's disease and endolymphatic hydrops. Otology & Neurotology. 2012;33(9):1685-91. 6. Hsu L, Zhu X-N, Zhao Y-S. Immunoglobulin E and circulating immune complexes in endolymphatic hydrops. Annals of Otology, Rhinology & Laryngology. 1990;99(7):535-8. 7. Garcia-Purrinos F, Ferri E, Rosell A, Calvo J. Combined intratympanic and intravenous dexomethasone to control vertigo in Meniere disease. Acta otorrinolaringologica espanola. 2005;56(2):74-7. 8. Shea JJ. Autoimmune sensorineural hearing loss as an aggravating factor in Meniere's disease. Neurophysiological and Clinical Aspects of Vestibular Disorders. 30: Karger Publishers; 1983. p. 254-7. 9. Xenellis J, Morrison A, McClowskey D, Festenstein H. HLA antigens in the pathogenesis of Meniere's disease. The Journal of Laryngology & Otology. 1986;100(1):21-4. 10. Duntas LH, Mantzou E, Koutras DA. Circulating levels of oxidized low-density lipoprotein in overt and mild hypothyroidism. Thyroid. 2002;12(11):1003-7. 11. Goebel JA. 2015 Equilibrium Committee amendment to the 1995 AAO-HNS guidelines for the definition of Meniere's disease. Otolaryngology--Head and Neck Surgery. 2016;154(3):403-4. 12. Kim C-H, Shin JE, Yoo MH, Park HJ. Direction-changing and direction-fixed positional nystagmus in patients with vestibular neuritis and meniere disease. Clinical and Experimental Otorhinolaryngology. 2019;12(3):255. 13. Alexander TH, Harris JP. Current epidemiology of Meniere's syndrome. Otolaryngologic Clinics of North America. 2010;43(5):965-70. 14. Shambaugh Jr GE. Endocrine aspects of meniere's disease. The Laryngoscope. 1959;69(8):1027-32. 15. Powers WH. Metabolic aspects of Meniere's disease. The Laryngoscope. 1978;88(1):122-9. 16. Kinney SE. The metabolic evaluation in Meniere's disease. Otolaryngology-Head and Neck Surgery. 1980;88(5):594-8. 17. Meyerhoff WL, Paparella MM, Gudbrandsson FK. Clinical evaluation of Meniere's disease. The Laryngoscope. 1981;91(10):1663-8. 18. Evans K, Baldwin D, Bainbridge D, Morrison A. Immune status in patients with Meniere's disease. Archives of oto-rhino-laryngology. 1988;245(5):287-92. 19. Seo T, Node M, Yukimasa A, Sakagami M. Furosemide loading vestibular evoked myogenic potential for unilateral Ménière's disease. Otology & neurotology. 2003;24(2):283-8. 20. Colebatch J, Halmagyi G. Vestibular evoked potentials in human neck muscles before and after unilateral vestibular deafferentation. Neurology. 1992;42(8):1635-. 21. Halmagyi G, Colebatch J, Curthoys I. New tests of vestibular function. Bailliere's clinical neurology. 1994;3(3):485-500. 22. Jacobson G. mccaslin DL. The Vestibular-Evoked Myogenic Potential and Other Sonomotor Evoked Potentials. Auditory Evoked Potentials Basic Principles and Clinical Application. USA Lippincott Williams & Wilkins. 2007;8(27):572-98. 23. Jacobson G, McCaslin D. The vestibular evoked myogenic potential and other sonomotor evoked potentials. Lippincott Williams & Wilkins Baltimore, Md, USA; 2007. p. 572-98.
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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.
Enas Mostafa Osman, lecturer study chair
audiovestibular medicine, assiut university
mohamed salama bakr, professor study director
audiovestibular medicine, assiut university
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, 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 3 inclusion and 2 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 19 Apr 2022. 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?
Contact Amira Ali Abdelazeem mohamed, resident (01014123902, amiraalia9220@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early detection of endolymphtic hydrops in hypothyroid patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334771, which also lists 1 linked publication.
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 19 Apr 2022.