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Идёт набор NCT03646214

Improving Sleep Quality During Pregnancy Using an Oral Appliance

Без фазы С лечением Snoring Sleep Fragmentation

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: Midline traction oral appliance.
Кому может быть актуально
Состояния в реестре: Snoring, Sleep Fragmentation. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial

Обзор

Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. It may also impact fetal outcomes negatively. The purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. Sleep quality is evaluated objectively using an un-intrusive home sleep test system.

Подробное описание

As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time points: T0 - Baseline prior to OA use for two consecutive nights; T1- first two consecutive nights wearing the OA; T2 - for two consecutive nights after 4 weeks of appliance use. In addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. All participants will be given the opportunity to use their OAs after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. Participants will get to keep and use their OAs after the study.

Pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. Those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.

Вмешательства

  • Устройство Midline traction oral appliance
    Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.

Первичные конечные точки

  • Ratio of stable to unstable sleep from CPC [Срок оценки: Two nights of sleep recordings at each of 3 time point over 5 weeks.]
Вторичные конечные точки (5)
  • Number of snores per hour of sleep [Срок оценки: At each of 3 time points over 5 weeks]
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: At baseline and after 5 weeks]
  • Insomnia Sleep Questionnaire (ISQ) [Срок оценки: At baseline and after 5 weeks]
  • Hamilton Depression Rating Scale (HDRS) [Срок оценки: At baseline and after 5 weeks]
  • Fatigue Severity Scale (FSS) [Срок оценки: At baseline and after 5 weeks]

Критерии участия

Критерии включения

  • Pregnant adults who snore
  • At least 8 teeth per arch
  • Mallampati score from I to II
  • Palatine tonsils grade 0,1 or 2
  • Capable of giving verbal and written informed consent
  • Able to apply the sleep recorder and the oral appliance.

Критерии исключения

  • Pregnant > 32 weeks
  • Uncontrolled serious health issues
  • Cardiovascular or cardiac rhythm disorders
  • Pharmacological dependency
  • Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
  • Ongoing temporomandibular joint disorders
  • Loose teeth or periodontal disease
  • History of uvulopalatopharyngoplasty (UPPP)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Texas A&M University College of Dentistry — Dallas

Идентификаторы

NCT: NCT03646214 · IRB2018-0048

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗