Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Adherence to PAP Therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •On CPAP or BiPAP prior to spinal cord injury
- •Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2>50 mm Hg)
研究组 & 干预措施
CPAP Therapy
干预措施: CPAP (Device)
BiPAP Therapy
干预措施: BiPAP (Device)
结局指标
主要结局
Adherence to PAP Therapy
时间窗: 4 weeks
Median hours of PAP device use per night, objectively measured via device download. Additional metrics include: % days used \>4 hrs/night, total # of days used, total # of hours used.
次要结局
- Fatigue(4 weeks)
- PAP side effects(4 weeks)
- Sleep Quality(4 weeks)
- Daytime Sleepiness(4 weeks)
- Recruitment Rate(4 weeks)
研究者
Najib Ayas
Principal Investigator
University of British Columbia
