Skip to content

Improving turning exercises to better treat dizziness caused by loose inner ear crystals.

Optimising Particle Reposition Maneuvers to Improve BPPV Treatment (ORBIT-trial) - Optimising Particle Reposition Maneuvers to Improve BPPV Treatment (ORBIT-trial)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58272
Enrollment
400
Registered
2025-11-03
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPPV, Benign Paroxysmal Positional Vertigo, Canalolithiasis, Postional Vertigo Dizziness from loose ear crystals, Positional dizziness

Interventions

Standard treatment (i.e., usual care currently provided outside of the study):Questionnaires: Dizziness Handicap Inventory (DHI), Activities-specific Balance Confidence Scale (ABC-16), Hospital Anxiet
Depression Scale (HADS), Niigata PPPD Questionnaire (NPQ), Nijmegen Hyperventilation Questionnaire (NHV), and Euro Quality of Life (EQ-5D). A comprehensive intake (partly based on the questionnaire re
Intervention related to the study:This is a prospective single-blind randomized controlled trial (RCT). All enrolled participants will receive the standard care that is currently provided in clinical

Sponsors

Albert Schweitzer Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age equal to or above 18 years.At least a basic understanding of the Dutch language (minimum CEFR level B1 — independent user, threshold level) and mentally competent.Diagnosis of BPPD according to the Bárány Society criteria.

Exclusion criteria

Exclusion criteria: Age under 18 years.Severe cognitive impairment that prevents adequate understanding of study participation.Participants must not have any known (peripheral or central) vestibular disorder, except for BPPD, prior to participation in the study.Severe spinal disorders that represent a contraindication for performing the particle repositioning maneuvers.Very poor balance, where the patient is unable to stand independently without support.

Design outcomes

Secondary

MeasureTime frame
Type of affected semicircular canal (anterior, posterior, or horizontal) and variant (apogeotropic versus geotropic, and canalolithiasis versus cupulolithiasis).Comparison of questionnaire outcomes before and after treatment (ABC-16, DHI, EQ-5D, NPQ, NHV, and HADS).Comparison of the VAS scores as a measure of discomfort during the positional test between the two groups (experimental group versus control group).Recurrence of BPPD during follow-up (1 year).Comparison of the number of fall incidents before and after treatment at 1-year follow-up.

Primary

MeasureTime frame
Number of treatments (using particle repositioning maneuvers) required to completely resolve BPPV (experimental treatment group versus standard treatment group). This is defined as a negative positional test (i.e., no detectable nystagmus on VNG) and no increase in subjective dizziness symptoms during the test.Percentage of patients with a successfully completed treatment versus those with an unsuccessful treatment outcome for BPPV.

Countries

Netherlands

Contacts

Public ContactJ. Venhovens

Albert Schweitzer Ziekenhuis

j.venhovens@asz.nl078-6542398

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026