Идёт набор NCT05939934

Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal

Без фазы С лечением Sleep Apnea, Obstructive Endothelial Dysfunction

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: Mandibular advancement device treatment.
Кому может быть актуально: Состояния в реестре: Sleep Apnea, Obstructive, Endothelial Dysfunction. Базовые параметры: 18 лет — 75 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: Франция
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

Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial

Обзор

Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.

Подробное описание

Patients are recruited during sleep consultations in the Angers University Hospital pneumology department among patients followed for severe OSAHS and treated with CPAP. All of the scheduled examinations are carried out in the sleep laboratory of the CHU d'Angers.

Patients meeting the inclusion criteria and not having any non-inclusion criteria are randomized to the "MAD" group or to the "control" group. For patients in the "MAD" group, an appointment with a stomatologist is organized to make and adjust a thermo-molded type MAD.

An initial assessment is carried out for all patients during a day hospitalization specific to the study (study of endothelial function, blood pressure, Osler test, ECG, venous and urinary sampling, and completion of the study questionnaires).

Patients are then asked to stop CPAP treatment for two weeks. Patients in the OAM group use OAM during this period. Patients in the control group do not receive any specific treatment for their OSAHS during this period.

After 2 weeks of stopping CPAP, a second assessment, identical to the initial assessment, is carried out for all patients. This assessment is carried out during one night of hospitalization which also allows a PSG to be carried out under OAM or without treatment.

At the end of this assessment, the study is terminated and the patients resume their usual use of CPAP.

Вмешательства

Устройство Mandibular advancement device treatment
a titratable thermoplastic mandibular advancement device will be proposed to patient in the experimental group during the 2 weeks of CPAP withdrawal.

Первичные конечные точки

Change in subjective sleepiness [Срок оценки: before and two weeks after CPAP withdrawal]

Вторичные конечные точки (11)

Change in objective sleepiness [Срок оценки: before and two weeks after CPAP withdrawal]
Change in subjective sleep quality [Срок оценки: before and two weeks after CPAP withdrawal]
Change in executive function [Срок оценки: before and two weeks after CPAP withdrawal]
Change in 24 hour blood pressure [Срок оценки: before and two weeks after CPAP withdrawal]
Change in endothelial function [Срок оценки: before and two weeks after CPAP withdrawal]
Change in cardiac repolarization [Срок оценки: before and two weeks after CPAP withdrawal]
Change in catecholamines levels [Срок оценки: before and two weeks after CPAP withdrawal]
Change in glucose levels [Срок оценки: before and two weeks after CPAP withdrawal]
Change in Microparticles [Срок оценки: before and two weeks after CPAP withdrawal]
Change in oxydative stress [Срок оценки: before and two weeks after CPAP withdrawal]
Change in inflammation [Срок оценки: before and two weeks after CPAP withdrawal]

Критерии участия

Критерии включения

Patient accepting MAD treatment
Patient with an apnea-hypopnea index (AHI) greater than 15 events per hour on the initial recording
Patient with excessive daytime sleepiness during initial treatment (ESE>10)
Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night