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Идёт набор NCT06524856

The Increase of Lung Capacity Using the Lung Master (Pulmonary Exerciser)

Без фазы С лечением Dyspnea Chronic Obstructive Pulmonary Disease Asthma

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: Lung Master (Pulmonary Exerciser).
Кому может быть актуально
Состояния в реестре: Dyspnea, Chronic Obstructive Pulmonary Disease, Asthma. Базовые параметры: от 19 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
США
Следующий шаг
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Обзор

Investigators are studying how a device called The Lung Master device can help people breathe better. The investigational device increases the amount of air our lungs can hold, which is important for overall lung health. The Lung Master is not approved by the FDA. The study has two visits approximately one month apart. In the first visit participants will take a spirometry test, particularly forced vital capacity (FVC), to measure volume change in the lungs. Participants will take the investigational device home to use daily, either in the morning or evening. Use will be recorded in a diary. After one month, participants will return for another spirometry test. Each study visit will take about one to two hours to complete.

Подробное описание

Shortness of breath,or dyspnea, occurs when the lungs do not receive enough oxygen leading to discomfort when breathing. This occurs in a quarter of individuals seen in an outpatient setting. Several factors can relate to breathlessness, including lung disorders, heart conditions, or stress. Patients with breathlessness often experience physical limitations in their daily activities. Various treatments for dyspnea are available, however, chronic breathlessness syndrome, such as asthma or chronic obstructive pulmonary disease (COPD), still can persist even when treatment is available.

The Lung Master (Pulmonary Exerciser) is a breathing device used for the respiratory treatment and rehabilitation of chronic breathlessness syndrome. The Lung Master increases resistance during inhalation and exhalation, which works to strengthen the respiratory muscle and improve overall lung function. Therefore, this study will focus on determining how the Lung Master increases lung capacity in healthy individuals. The device is considered investigational and has not been approved by the FDA.

Two groups of healthy participants will be sought for the study: ages 19 to 35 and ages 65 and above. Each participant will have two in-office study visits approximately one month apart. Each visit will take around one to two hours to complete. At the visits, a breathing test called a spirometry test will be done. During the one month interim, the study device will be used at home and the use recorded in a diary. The device must be used least once every day, either in the morning or in the evening for 5 to 20 minutes. You will be contacted after two weeks, and then return the device at the second study visit.

Вмешательства

  • Устройство Lung Master (Pulmonary Exerciser)
    During the one-month using the Lung Master at their house, the participant will be using it at least one time every day, either in the morning or in the evening before going to sleep. During the session, the participants will sit upright and try to prolong the inhalation and exhalation breaths through the Lung Master device for at least three seconds. For each session, the participants will try to concentrate on 35-50 breaths in and breaths out which is about 2-5 minutes. Every session can invol

Первичные конечные точки

  • Inspiratory Capacity [Срок оценки: baseline and after one month of device use]
  • Tidal Volume [Срок оценки: baseline and after one month of device use]

Критерии участия

Критерии включения

  • able to complete the at home portion of the study daily
  • fall within the age ranges: 19-35 and above 65 years old

Критерии исключения

  • any respiratory or chronic conditions

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Biomechanics Research Building — Omaha

Публикации

  • Berliner D, Schneider N, Welte T, Bauersachs J. The Differential Diagnosis of Dyspnea. Dtsch Arztebl Int. 2016 Dec 9;113(49):834-845. doi: 10.3238/arztebl.2016.0834. PMID 28098068
  • Sandberg J, Olsson M, Ekstrom M. Underlying conditions contributing to breathlessness in the population. Curr Opin Support Palliat Care. 2021 Dec 1;15(4):219-225. doi: 10.1097/SPC.0000000000000568. PMID 34610625
  • David S, Goldin J, Edwards CW. Forced Expiratory Volume. 2024 Oct 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540970/ PMID 31082014
  • Nguyen JD, Duong H. Pursed-lip Breathing. 2025 Jan 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545289/ PMID 31424873

Идентификаторы

NCT: NCT06524856 · 0108-24-EP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗