- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07787559
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
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
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Ho Chi Minh City, Вьетнам
- Military Hospital 175
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Контакт:
- Chau Van Ha
- Номер телефона: (+84) 0963219277
- Электронная почта: hachau.ht89@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Semont-Plus
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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.
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Активный компаратор: Epley
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Change in average slow-phase velocity of positional nystagmus
Временное ограничение: Before the maneuver, 30 minutes after the maneuver, and 3 days after the maneuver
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Before the maneuver, 30 minutes after the maneuver, and 3 days after the maneuver
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Proportion of participants with a successful repositioning maneuver
Временное ограничение: 30 minutes and 3 days after the first treatment maneuver
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30 minutes and 3 days after the first treatment maneuver
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Number of days until resolution of positional vertigo
Временное ограничение: From the enrolment visit (day 0) to 1 month
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From the enrolment visit (day 0) to 1 month
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Number of participants with adverse events during treatment
Временное ограничение: From the enrolment visit (day 0) to 1 month
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From the enrolment visit (day 0) to 1 month
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Correlation between the number of self-administered maneuvers per day and time to resolution of positional vertigo
Временное ограничение: From the enrolment visit (day 0) to 1 month
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From the enrolment visit (day 0) to 1 month
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- DTCSHY.24/26/175.A7
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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