Early Detection of Endolymphatic Hydrops in Hypothyroid Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05334771
Collaborator
(none)
50
31

Study Details

Study Description

Brief Summary

Early detection of endolymphatic hydrops in hypothyroid patients Study outcome of medical treatment for hypothyroid patients

Condition or Disease Intervention/Treatment Phase
  • Device: Dual band pure tune audiometer

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

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Early Detection of Endolymphatic Hydrops in Hypothyroid Patients
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Early detection of endolymphtic hydrops in hypothyroid patients [Baseline]

    Cervical vestibular evoked myogenic potential

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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

Exclusion Criteria:

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

.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Enas Mostafa Osman, lecturer, audiovestibular medicine, assiut university
  • Study Director: mohamed salama bakr, professor, audiovestibular medicine, assiut university

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amira Ali Abdelazeem Mohamed, princible invistigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05334771
Other Study ID Numbers:
  • Hypothyroidism
First Posted:
Apr 19, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2022