Идёт набор NCT06627283

Effects of Respiratory Muscle Training on Tongue Muscle Function

Без фазы С лечением Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: IMT, EMT, Sham.
Кому может быть актуально: Состояния в реестре: Healthy. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бельгия, Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Respiratory Muscle Training on Tongue Muscle Function in Healthy Subjects, a Randomized Controlled Trial.

Обзор

This study aims to investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. We hypothesize that respiratory muscle training can improve strength and endurance of the tongue muscles.

Подробное описание

In patient with obstructive sleep apnea, studies have shown that respiratory muscle training improved sleep-related outcomes in patients with obstructive sleep apnea (OSA). On the other hand, a recent study showed that expiratory muscle training improved tongue motor strength in patients with OSA. We hypothesize that respiratory muscle training (either Inspiratory Muscle Training (IMT) or Expiratory Muscle Training (EMT)) may elicit sleep-related improvement in patient with OSA through enhancement on tongue muscle function.

To investigate our hypothesis, we will first address this question in a population of healthy subjects. This study will therefore investigate the effects of respiratory muscle training on tongue muscle function in healthy subjects. The primary hypothesis is that the IMT program with lead to an increase in tongue strength compared to the control group. Other hypothesizes are that EMT, but not sham, will also lead to an increase in tongue strength, compared to the control group.

Вмешательства

Устройство IMT
Description: A pressure threshold loading device will be used: the POWERbreathe Medic (load range 10-90 cmH2O). Participants will be instructed to exhale passively during normal tidal breathing through the training device (until functional residual capacity) and to perform deep inspirations against the external load. The first week, the resistance will be fixed at 30% of the baseline measured maximal inspiratory pressure (MIP). Participants will be instructed to increase the resistance by 10% of
Устройство EMT
A pressure threshold loading device will be used: the POWERbreathe Ex1 EMT Medic (load range 10-90 cmH2O) or POWERbreathe Ex1 EMT MR (load range 35-175 cmH2O) depending on their baseline MEP measurement. Participants will be instructed to inhale quietly during normal tidal breathing through the training device and to perform rapid and deep exhalation against the external load. The first week, the resistance will be fixed at 30% of the baseline measured MEP. Participants will be instructed to inc
Устройство Sham
A pressure threshold loading device will be used: the POWERbreathe Ex1 EMT Medic or MR, but with the resistance mechanism inside removed and replaced by a plastic ball. The same instructions will be given as for the EMT group, except that there will be no or minimal resistance (less than 6 cmH2O). There will be no change in resistance over the weeks.

Первичные конечные точки

Tongue elevation strength [Срок оценки: Measured two times: at baseline and after 8 weeks]

Вторичные конечные точки (10)

Tongue protrustion strength [Срок оценки: Measured two times: at baseline and after 8 weeks]
Tongue elevation endurance [Срок оценки: Measured two times: at baseline and after 8 weeks]
Tongue protrusion endurance [Срок оценки: Measured two times: at baseline and after 8 weeks]
Maximal inspiratory pressure [Срок оценки: Measured two times: at baseline and after 8 weeks]
Maximal expiratory pressure [Срок оценки: Measured two times: at baseline and after 8 weeks]
Snoring intensity [Срок оценки: Measured two times: at baseline and after 8 weeks]
Tongue base thickness [Срок оценки: Measured two times: at baseline and after 8 weeks]
Total sagittal thickness [Срок оценки: Measured two times: at baseline and after 8 weeks]
Lateral pharyngeal wall thickness [Срок оценки: Measured two times: at baseline and after 8 weeks]
Snoring duration [Срок оценки: Measured two times: at baseline and after 8 weeks]

Критерии участия

Критерии включения

Community ambulant adults between 18 to 65 years old as of testing day; able to understand French or Dutch (depending on the study's site of inclusion); BMI ≥ 18 and ≤ 30 kg/m².

Критерии исключения

Any diagnosed neuromuscular or cardiorespiratory disease; diagnosed psychiatric or psychological disorders which could affect adherence to or comprehension of instructions; diagnosed eating disorders; previous or ongoing head and neck cancer; diagnosed OSA; presenting a high-risk of sleep-disordered breathing indicated by a NoSAS score of 8 or higher 32 or a STOP-Bang score of 3 or higher 33,34; resting heart rate (HR) \> 100 beats per minute (bpm) or \< 50 bpm; resting systolic blood pressure (SBP) \> 140 or \< 90 mmHg, diastolic blood pressure (DBP) \> 90 or \< 50 mmHg; oxygen saturation (SpO2) \< 94% at rest on room air. Individuals with abnormal lung function, i.e., forced expiratory volume in 1 second (FEV1) ≤ 80%, forced vital capacity (FVC) ≤ 80%, and FEV1/FVC ≤ 70%, will also be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да