Набор скоро начнётся NCT06818604

Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries

Без фазы С лечением Spinal Cord Injuries (SCI) Sleep Disordered Breathing (SDB) Sleep Apnea Cervical Spinal Cord Injruy

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: CPAP, BiPAP.
Кому может быть актуально: Состояния в реестре: Spinal Cord Injuries (SCI), Sleep Disordered Breathing (SDB), Sleep Apnea, Cervical Spinal Cord Injruy. 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: Канада
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

Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study

Обзор

Sleep-disordered breathing (SDB) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. The condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. Positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (CPAP), which applies the same pressure during inhalation and exhalation, difficult to use. Bilevel positive airway pressure (BiPAP) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. However, limited evidence compares CPAP and BiPAP in individuals with cervical spinal cord injuries. This pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe SDB (defined as an AHI of 15 events/hour or greater). Participants will be randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. The investigators aim to determine whether BiPAP improves adherence and symptoms compared to CPAP in this patient population.

Вмешательства

Устройство CPAP
Participants randomized to this group will receive auto-CPAP therapy. The device will be initiated by a respiratory therapist at GF Strong Rehabilitation Centre. Settings will be adjusted to achieve a device efficacy index \< 5 events per hour.
Устройство BiPAP
Participants will receive BiPAP S mode therapy for 4 weeks. The device will be initiated by a respiratory therapist at GF Strong Rehabilitation Centre with initial settings of IPAP 8 cmH2O and EPAP 3 cmH2O. Settings will be modified to a maximum tolerated level to achieve a tidal volume of 8 mL/kg ideal body weight and SpO2 \> 95%. Overnight oximetry will be performed to ensure at least 4 hours of device use, and settings will be adjusted to achieve a DEI \< 5 events per hour.

Первичные конечные точки

Adherence to PAP Therapy [Срок оценки: 4 weeks]

Вторичные конечные точки (5)

Daytime Sleepiness [Срок оценки: 4 weeks]
Sleep Quality [Срок оценки: 4 weeks]
Fatigue [Срок оценки: 4 weeks]
PAP side effects [Срок оценки: 4 weeks]
Recruitment Rate [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

Age >= 19 years
Cervical spinal cord injury (ASIA A, B, or C). This will include patients with upper (C1-C4) and lower (C5-C7) spinal cord injuries
Presence of sleep disordered breathing, defined as AHI > =15 events/hour by home sleep apnea test (HSAT)