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Предстои набиране Не е приложимо NCT06972589

The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.

Не е приложима фаза (напр. обсервационно)
Заболявания: COPD (Chronic Obstructive Pulmonary Disease) Obesity Hypoventilation Syndrome (OHS)

Спонсор: Fisher and Paykel Healthcare

Налично на: БГ
Обобщение
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV) delivers positive pressures via an interface such as a face mask and has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. However, poor performance of the NIV mask and poor comfort can make NIV therapy harder to tolerate. This study will assess if a new mask helps to improve the breathing of people on NIV and normalize blood gases.
Описание
Participants are moved to the sleep laboratory for the night where they are provided with beds. * The participants are put on their prescribed airway pressure support with the first randomized mask. * After at least 60 minutes of recording, participants are awakened to switch back to the second mask. They are then allowed to sleep uninterrupted for the rest of the night.
Кой може да участва
Inclusion Criteria: * Age over 18 years * Prescribed nocturnal NIV for COPD or OHS * Able to complete an overnight sleep study * Comfortable to sleep on a standard double bed * Capacity to complete informed consent Exclusion Criteria: * Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data) * Prescribed IPAP above 25 cmH2O * Allergic to adhesive of the sensors * Self-reported cold/flu symptoms
Места на провеждане 1
New Zealand (1)
Fisher and Paykel Healthcare Sleep Laboratory
Auckland
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.05.2025
Крайна дата
01.04.2026
Регистрационен номер
NCT06972589
Източник
anzctr
Запитване за медицински туризъм

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