Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo

25 augusti 2026 uppdaterad av: Hoang Tien Trong Nghia, Military Hospital 175

Efficacy of the Epley Versus Semont-plus Maneuver in Patients With Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: A Randomized Controlled Trial Using Quantitative Video-Nystagmography Measurement

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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

160

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Military Hospital 175
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Semont-Plus
Procedur: Semont-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.
Aktiv komparator: Epley
Procedur: Epley
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change in average slow-phase velocity of positional nystagmus
Tidsram: Before the maneuver, 30 minutes after the maneuver, and 3 days after the maneuver
Before the maneuver, 30 minutes after the maneuver, and 3 days after the maneuver

Sekundära resultatmått

Resultatmått
Tidsram
Proportion of participants with a successful repositioning maneuver
Tidsram: 30 minutes and 3 days after the first treatment maneuver
30 minutes and 3 days after the first treatment maneuver
Number of days until resolution of positional vertigo
Tidsram: From the enrolment visit (day 0) to 1 month
From the enrolment visit (day 0) to 1 month
Number of participants with adverse events during treatment
Tidsram: From the enrolment visit (day 0) to 1 month
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
Tidsram: From the enrolment visit (day 0) to 1 month
From the enrolment visit (day 0) to 1 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Military Hospital 175

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

30 oktober 2027

Avslutad studie (Beräknad)

30 november 2027

Studieregistreringsdatum

Först inskickad

22 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

22 augusti 2026

Första postat (Faktisk)

26 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 augusti 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • DTCSHY.24/26/175.A7

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera