Benign Paroxysmal Positional VertigoNCT05446506
Serum Levels of Otolin-1 and Vitamin D in Pre- and Post-treatments of BPPV
An observational study of Benign Paroxysmal Positional Vertigo, run by Chiang Mai University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- How many people
- 21 participants
- Where
- 1 siteThailand
- Study dates
- 13 Jan 2021to 28 Feb 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum
Chiang Mai, 50200
About this study
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
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.
Read the detailed 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.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- otolin-1, vitamin D, biomarker, inner ear
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of serum otolin-1 and vitamin D
changes of Level of serum otolin-1 and vitamin D before and after treatment of BPPV
Measured: Day 0 and 7±3days after treatment
Secondary outcomes (1)
Correlation of serum otolin-1 and vitamin D
Correlation of serum otolin-1 and vitamin D before and after treatment period in BPPV patients
Measured: Day 0 and 7±3days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start13 Jan 2021
- Primary completion30 Sep 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwicha Isaradisaikul Kaewsiri, Chiang Mai University
- Investigators
- Suwicha Kaewsiri, MD, Principal investigator, Department of Otolaryngology , Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446506
- Sponsor's protocol ID
- ENT-2563-07658
- Status last verified
- Aug 2023
- First submitted
- 12 Apr 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25245136Isaradisaikul 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.
PubMed 20567978Lynn 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.
PubMed 7501382Burton 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.
PubMed 22886077Bhattacharyya 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.
PubMed 28248602Mulry E, Parham K. Inner Ear Proteins as Potential Biomarkers. Otol Neurotol. 2020 Feb;41(2):145-152. doi: 10.1097/MAO.0000000000002466.
PubMed 31789810Sacks 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.
PubMed 26375977Koestner 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.
PubMed 5464974Parham 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.
PubMed 29533337Wu 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.
PubMed 32477244
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05446506
- Acronym / sponsor ID
- ENT-2563-07658
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- otolin-1, vitamin D, biomarker, inner ear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 6 Jul 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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of serum otolin-1 and vitamin D
Time frame: Day 0 and 7±3days after treatment
changes of Level of serum otolin-1 and vitamin D before and after treatment of BPPV
1 secondary outcome
Correlation of serum otolin-1 and vitamin D
Time frame: Day 0 and 7±3days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Results publication: PubMed 25245136Parham 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.
- Results publication: PubMed 20567978Isaradisaikul 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.
- Results publication: PubMed 7501382Lynn 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.
- Results publication: PubMed 22886077Burton 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.
- Results publication: PubMed 28248602Bhattacharyya 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.
- Results publication: PubMed 31789810Mulry E, Parham K. Inner Ear Proteins as Potential Biomarkers. Otol Neurotol. 2020 Feb;41(2):145-152. doi: 10.1097/MAO.0000000000002466.
- Results publication: PubMed 26375977Sacks 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.
- Results publication: PubMed 5464974Koestner 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.
- Results publication: PubMed 29533337Parham 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.
- Results publication: PubMed 32477244Wu 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.
- Individual participant dataSharing planned: No
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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.
Suwicha Kaewsiri, MD principal investigator
Department of Otolaryngology , Faculty of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Paroxysmal Positional Vertigo, run by Chiang Mai University at 1 site in Thailand.
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 10 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: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Level of serum otolin-1 and vitamin D (time frame: Day 0 and 7±3days after treatment). 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 NCT05446506, which also lists 10 linked publications.
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 31 Aug 2023.