Serum Levels of Otolin-1 and Vitamin D in Pre- and Post-treatments of BPPV

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

Comparative Study for Serum Levels of Otolin-1 and Vitamin D in pre-and Post-treatments of Patients With Benign Paroxysmal Positional Vertigo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446506
• Other study ID #: ENT-2563-07658
• Status: Completed
• Start date: January 13, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: August 2023
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

BPPV is the most common cause of vertigo. The pathophysiology of BPPV has not been cleared, several studies show that symptoms are caused by the displacement of otoconia from the macula of the utricle into the semicircular canals. These calcium carbonate particles then stimulate non-physiological movement of the endolymph leading to a false sensation of angular acceleration.

Biomarkers represent measurable products of biological processes, thus making an assessment of those processes more practical. Biomarkers in circulation are powerful indicators of normal and pathological biological processes, as well as, responses to pharmacological treatments. The inner ear-inclusive protein that has been published included Otolin-1, Otoconin-90/95, Prestin, Otoancorin, Otogelin, α-tectorin, β-tectorin and Cochlin.

Description:

The posterior canal BPPV is the most common BPPV variant, diagnosed with the Dix-Hallpike test. The lateral canal BPPV is diagnosed with a supine roll test. After treatment of the posterior canal BPPV with a single cycle of the CRP, the rate of negative DHT was 68-80% in the 1st week. Rate of an absence of vertigo and nystagmus on the supine roll test after-treatment of the lateral canal BPPV with the barbecue maneuver plus forced prolonged positioning was 81%.

Biomarkers are often measured in body fluids, they eliminate the need for costly modalities to diagnose and monitor progression. Otolin-1 is a secreted glycoprotein whose messenger RNA (mRNA) expression is restricted to the inner ear, specifically the support cells of the vestibular maculae, semicircular canal cristae, organ of Corti, and marginal cells of the stria vascularis. Otolin-1 blood levels are significantly higher in patients older than 65 years old and increased prevalence of BPPV with age. There were reports of a relationship between vitamin D and otolin-1. Significantly higher serum levels of the otolin-1 protein in patients with BPPV than in healthy controls has been reported. This also confirmed evidence of the otolin-1 as a potential biomarker for BPPV episodes and maybe clinically used to promote better management of BPPV. No data on inner ear biomarkers has been exited in Thailand.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 28, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18 - 80 years

2. History of brief episodes of positioning vertigo

3. Positive positioning test; either Dix-Hallpike test or supine roll test in one or both ears

4. First diagnosis of BPPV or recurrent BPPV

Exclusion Criteria:

1. Clinical symptoms or sign of other central or peripheral vestibular disorder

2. Previous history of balance disorders (for controlled group) or Previous history of balance disorders except BPPV (for BPPV group)

3. Active infection

4. Active cancer disease

5. Conditions that may affect the level of otolin-1 such as previous mastoidectomy

6. Conditions that may affect the level of vitamin D such as cardiovascular disease, diabetes mellitus type2, chronic liver disease, osteoporosis osteomalacia and active symptoms of migraine

7. Major health conditions; except common chronic conditions e.g. hypertension, hypothyroidism, hypercholesterolemia, and reflux

8. Major systemic illness, were undergoing active cancer treatment, took prednisone above 10 mg daily, took other immunosuppressive drugs, took any medications for rheumatoid arthritis other than NSAIDs, or had received antibiotics in the previous 6 months

9. Unable to complete Thai-Dizziness handicap inventory questionnaire

10. Unable to obtain the blood specimen

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Locations

Country	Name	City	State
Thailand	Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (10)

Bhattacharyya N, Gubbels SP, Schwartz SR, Edlow JA, El-Kashlan H, Fife T, Holmberg JM, Mahoney K, Hollingsworth DB, Roberts R, Seidman MD, Prasaad Steiner RW, Tsai Do B, Voelker CC, Waguespack RW, Corrigan MD. Clinical Practice Guideline: Benign Paroxysma — View Citation

Burton MJ, Eby TL, Rosenfeld RM. Extracts from the Cochrane Library: modifications of the Epley (canalith repositioning) maneuver for posterior canal benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 2012 Sep;147(3):407-11. doi: 10.1177/01 — View Citation

Isaradisaikul S, Navacharoen N, Hanprasertpong C, Kangsanarak J, Panyathong R. Causes and time-course of vertigo in an ear, nose, and throat clinic. Eur Arch Otorhinolaryngol. 2010 Dec;267(12):1837-41. doi: 10.1007/s00405-010-1309-9. Epub 2010 Jun 22. — View Citation

Koestner A, Long JF. Ultrastructure of canine distemper virus in explant tissue cultures of canine cerebellum. Lab Invest. 1970 Aug;23(2):196-201. No abstract available. — View Citation

Lynn S, Pool A, Rose D, Brey R, Suman V. Randomized trial of the canalith repositioning procedure. Otolaryngol Head Neck Surg. 1995 Dec;113(6):712-20. doi: 10.1016/S0194-59989570010-2. — View Citation

Mulry E, Parham K. Inner Ear Proteins as Potential Biomarkers. Otol Neurotol. 2020 Feb;41(2):145-152. doi: 10.1097/MAO.0000000000002466. — View Citation

Parham K, Kuchel GA, McElhaney JE, Haynes L. A Relationship Between Blood Levels of Otolin-1 and Vitamin D. Otol Neurotol. 2018 Apr;39(4):e269-e273. doi: 10.1097/MAO.0000000000001747. — View Citation

Parham K, Sacks D, Bixby C, Fall P. Inner ear protein as a biomarker in circulation? Otolaryngol Head Neck Surg. 2014 Dec;151(6):1038-40. doi: 10.1177/0194599814551127. Epub 2014 Sep 22. — View Citation

Sacks D, Parham K. Preliminary Report on the Investigation of the Association Between BPPV and Osteoporosis Using Biomarkers. Otol Neurotol. 2015 Sep;36(9):1532-6. doi: 10.1097/MAO.0000000000000853. — View Citation

Wu Y, Han W, Yan W, Lu X, Zhou M, Li L, Guan Q, Fan Z. Increased Otolin-1 in Serum as a Potential Biomarker for Idiopathic Benign Paroxysmal Positional Vertigo Episodes. Front Neurol. 2020 May 13;11:367. doi: 10.3389/fneur.2020.00367. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of serum otolin-1 and vitamin D	changes of Level of serum otolin-1 and vitamin D before and after treatment of BPPV	Day 0 and 7±3days after treatment
Secondary	Correlation of serum otolin-1 and vitamin D	Correlation of serum otolin-1 and vitamin D before and after treatment period in BPPV patients	Day 0 and 7±3days after treatment