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

NCT05446506 | Completed

• 1 other identifier: ENT-2563-07658
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

otolin-1; vitamin D; biomarker; inner ear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of serum otolin-1 and vitamin D

  Day 0 and 7±3days after treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

BPPV cases in outpatient Ear Nose and Throat (ENT) Clinic at CMU Hospital, Faculty of Medicine, Chiang Mai University during the study period.

You may qualify if:

• Age 18 - 80 years
• History of brief episodes of positioning vertigo
• Positive positioning test; either Dix-Hallpike test or supine roll test in one or both ears
• First diagnosis of BPPV or recurrent BPPV

You may not qualify if:

• Clinical symptoms or sign of other central or peripheral vestibular disorder
• Previous history of balance disorders (for controlled group) or Previous history of balance disorders except BPPV (for BPPV group)
• Active infection
• Active cancer disease
• Conditions that may affect the level of otolin-1 such as previous mastoidectomy
• 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
• Major health conditions; except common chronic conditions e.g. hypertension, hypothyroidism, hypercholesterolemia, and reflux
• 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
• Unable to complete Thai-Dizziness handicap inventory questionnaire
• Unable to obtain the blood specimen

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum

Chiang Mai, 50200, Thailand

Location

Related Publications (10)

• 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.

  PMID: 25245136 RESULT

• 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.

  PMID: 20567978 RESULT

• 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.

  PMID: 7501382 RESULT

• 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: 10.1177/0194599812457134. Epub 2012 Aug 11.

  PMID: 22886077 RESULT

• 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 Paroxysmal Positional Vertigo (Update) Executive Summary. Otolaryngol Head Neck Surg. 2017 Mar;156(3):403-416. doi: 10.1177/0194599816689660.

  PMID: 28248602 RESULT

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

  PMID: 31789810 RESULT

• 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.

  PMID: 26375977 RESULT

• 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.

  PMID: 5464974 RESULT

• 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.

  PMID: 29533337 RESULT

• 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.

  PMID: 32477244 RESULT

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suwicha Kaewsiri, MD

  Department of Otolaryngology , Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Department of Otolaryngology

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: July 6, 2022
• Study Start: January 13, 2021
• Primary Completion: September 30, 2022
• Study Completion: February 28, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)