Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT06818604
Brief Summary:
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.
Study:
NCT06818604
Study Brief:
Protocol Section:
NCT06818604