Benign Paroxysmal Positional Vertigo (BPPV)
Conditions
Brief summary
The goal of this clinical trial is to learn which of two head-movement treatments works better for benign paroxysmal positional vertigo (BPPV) of the posterior canal in adults. BPPV is a common cause of short spells of spinning dizziness. It happens when tiny crystals come loose inside the balance organ of the inner ear and drift into one of its canals. Changing head position then brings on a spinning feeling, along with quick jerking movements of the eyes. The main question it aims to answer is: \* Does one treatment reduce these jerking eye movements more than the other, measured before treatment, 30 minutes after treatment, and 3 days after treatment? The study will also look at: * How many participants become free of positional dizziness after treatment * How many days pass before the dizziness stops * Whether repeating the treatment at home more times a day shortens recovery * How often unwanted effects, such as nausea or vomiting, happen with each treatment Researchers will compare the Semont-plus maneuver to the Epley maneuver, the long-standing standard treatment, to see if it clears the crystals out of the canal faster and more completely. Participants will: * Be placed by chance, into the Epley group or the Semont-plus group * Have the jerking movements of the eyes recorded with video goggles while the doctor moves their head into the position that brings on the dizziness * Receive their assigned maneuver at the hospital, followed by a second recording about 30 minutes later * Be taught to carry out the same maneuver on their own at home, as often as they feel able to * Come back after 3 days for another recording of their eye movements * Come back after 1 month to talk with the study team about how their dizziness changed over that time * Keep a short daily diary of their dizziness and of how many times a day they did the maneuver at home
Interventions
PROCEDURESemont-plus
Semont-plus liberatory maneuver for posterior canal BPPV, performed by a trained therapist at the enrolment visit. From the upright seated position the head is turned 45 degrees toward the nonaffected side. The body is then moved 150 degrees toward the affected side, so that the head comes to lie about 60 degrees below the earth horizontal and the otoconia are carried beyond the vertex of the canal. The body is next moved 240 degrees toward the nonaffected side, which drives the otoconia toward the vestibule, and the participant is finally brought 90 degrees back to the upright position. Each position is held for about one minute or until the induced nystagmus stops. The maneuver is repeated within the same session if positional nystagmus persists. Participants are then taught to perform it on their own at home, as often as they are able, and to record each home session in a diary.
PROCEDUREEpley
Epley maneuver for posterior canal BPPV, performed by a trained therapist at the enrolment visit. From the upright seated position the head is rotated 45 degrees toward the affected ear. The body is then moved backward so that the head hangs below the earth horizontal. The head is rotated 90 degrees toward the nonaffected ear, after which the whole body is rotated downward until the participant faces the floor with the affected ear pointing toward the ceiling. The participant returns to sitting with the head still rotated 45 degrees toward the nonaffected ear, and the head is turned back to neutral at the end. Each position is held until the induced nystagmus stops, and for at least 30 seconds. The maneuver is repeated within the same session if positional nystagmus persists. Participants are then taught to perform it on their own at home, as often as they are able, and to record each home session in a diary.
Sponsors
Military Hospital 175
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Posterior semicircular canal benign paroxysmal positional vertigo of the canalolithiasis type, diagnosed according to the Barany Society 2015 diagnostic criteria * Unilateral involvement of a single semicircular canal
Exclusion criteria
* Involvement of more than one semicircular canal * Any condition making the repositioning maneuver unsafe, including severe cervical spine disease with restricted range of motion or instability, previous cervical spine fracture, severe osteoporosis, unstable cardiovascular disease, or respiratory failure * Unable to cooperate with the maneuver * Any ocular or neurologic condition preventing technically adequate videonystagmography recording, such as inability to keep the eyes open, severe ptosis, or interfering spontaneous nystagmus from another cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in average slow-phase velocity of positional nystagmus | Before the maneuver, 30 minutes after the maneuver, and 3 days after the maneuver |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with a successful repositioning maneuver | 30 minutes and 3 days after the first treatment maneuver |
| Number of days until resolution of positional vertigo | From the enrolment visit (day 0) to 1 month |
| Correlation between the number of self-administered maneuvers per day and time to resolution of positional vertigo | From the enrolment visit (day 0) to 1 month |
| Number of participants with adverse events during treatment | From the enrolment visit (day 0) to 1 month |
Countries
Vietnam
Outcome results
None listed