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临床试验/NCT06818604
NCT06818604尚未招募不适用

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

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

Experimental

干预措施: CPAP (Device)

BiPAP Therapy

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Najib Ayas

Principal Investigator

University of British Columbia

研究点 (1)

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