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Набор скоро начнётся NCT07077278

Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome

Фаза IV С лечением Idiopathic Hypersomnia POTS - Postural Orthostatic Tachycardia Syndrome

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: Low sodium oxybate (LXB), Placebo.
Кому может быть актуально
Состояния в реестре: Idiopathic Hypersomnia, POTS - Postural Orthostatic Tachycardia Syndrome. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
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Официальное название

Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome: a Placebo-controlled, Double-blind, Randomized Withdrawal Study

Обзор

The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS). Previous research has shown that patients with IH also report having symptoms associated with POTS. The researchers have observed that in patients with both IH and POTS, when patients' sleep quality improves, so do their POTS symptoms. The goal of this study is to test this in a controlled way by using LXB as a treatment for both IH and POTS in patients that have been diagnosed with both conditions.

Вмешательства

  • Препарат Low sodium oxybate (LXB)
    Participants will continue take low sodium oxybate (LXB) for two weeks after completing an open-label titration and dose optimization period of low sodium oxybate (LXB).
  • Препарат Placebo
    Participants will take placebo for two weeks after completing an open-label titration and dose optimization period of low sodium oxybate (LXB).

Первичные конечные точки

  • Overall COMPASS-31 Score as a measure of direct comparison between the two conditions across the two-week randomized withdrawal period. [Срок оценки: At the end of the two-week randomized withdrawal period]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • English speaking and capable of signing the informed consent form and comply with the protocol requirements
  • Diagnosis of IH based on ICSD-3 criteria
  • Diagnosis of POTS based on the 2011 Consensus Criteria
  • Oxybate naïve. Participants on daytime alerting medications at baseline can remain on these medications for the duration of the study, provided doses remain stable for the duration of the study. This rule also applies to medications prescribed for the treatment of POTS. All medications known to affect cardiovascular function will be held for the appropriate time periods prior to active stand testing so as not to influence results.
  • COMPASS 31 ≥ 40 at the screening visit
  • Agree to use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical trials

Критерии исключения

  • Hypersomnia due to another medical, behavioral, sleep, or psychiatric disorder
  • Evidence of untreated or inadequately treated sleep disordered breathing, defined as AHI ≥ 10
  • History of bipolar or psychotic disorders, major depressive episode, or current suicidal risk
  • Pregnant or lactating or intends to become pregnant during the study
  • History of or currently being treated for clinically significant ongoing cardiac arrythmia, heart failure, myocarditis, pulmonary embolism requiring anticoagulation, pulmonary fibrosis or other pulmonary diagnosis that in the investigator's opinion may contribute to symptoms of POTS
  • Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection or positive SARS-CoV-2 PCR test at screening
  • A medical condition that could confound the results of the study or put the participant at undue risk in the investigator's judgment
  • Intends to have surgery or procedures requiring anesthesia or conscious sedation during the study
  • Currently participating in another interventional clinical study
  • Unwilling to remain on a stable regimen of medications during the study
  • Use of or planned use of intravenous saline infusions during the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07077278 · 75300

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗