Stroke and CPAP Outcome Study 2 "SCOUTS2"

Recruiting

Phase 2 Results N/A

Trial Description

Obstructive sleep apnea (OSA) is associated with impaired stroke recovery. Treatment with continuous positive airway pressure (CPAP) may prevent this but is limited by poor adherence. In this study, the investigators will enroll eligible stroke patients undergoing inpatient rehabilitation into an intensive CPAP adherence protocol (iCAP) with an aim to increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP will include patient education and encouragement, device adjustments, close monitoring of adherence and a 3-night run-in period of APAP to identify those patients who 1. have OSA and 2. have APAP tolerance. If both criteria are met, APAP treatment with iCAP will continue during the rehabilitation stay and over a 3-month period. The goal of the intervention is to achieve 50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period. The investigators will evaluate if demographic, co-morbid or stroke-specific factors predict APAP adherence and assess the relationship between APAP adherence and neurological recovery. Successful completion of the project will establish the feasibility of a definitive trial assessing the ability of APAP to improve stroke recovery in the short-term and reduce the risk of recurrent stroke in the long-term.

Conditions

Interventions

  • Continuous positive airway pressure Device
    Intervention Desc: Auto-titrating Continuous Positive Airway Pressure (APAP) among patients admitted to a rehabilitation unit after ischemic or hemorrhagic stroke for 3 month treatment period.
    ARM 1: Kind: Experimental
    Label: CPAP intervention
    Description: Participants will receive 3 nights of auto-CPAP in order to identify those with OSA using flow resistance detected by the device. After 3 nights, those without apparent OSA or with central apnea, and those who simply do not tolerate CPAP will be excluded from the study. An intensive CPAP adherence protocol (iCAP) will be initiated, including collaborative care with rehabilitation nurses, the study's sleep technologist and overnight respiratory therapists. After the run-in period, the sleep technologist will meet at least twice weekly with CPAP-tolerant participants during their rehabilitation stay for further OSA education and encouragement with a target adherence of 4 hours per night. Participants diagnosed with OSA by the device and tolerant will continue CPAP therapy during rehabilitation and at home for a treatment period of 3 months. Adherence will be downloaded remotely from participant's machines to encourage adherence to treatment and troubleshoot any problems with the device.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants who continue APAP after the run-in period who have acceptable adherence at 3 months, using APAP for an average of at least 4 hours a night. 3 months No
Secondary Number of participants who continue APAP after the run-in period who are willing to continue APAP treatment at discharge from the rehabilitation unit. Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation No
Secondary Functional Independence Measure (FIM) efficiency Between admission to rehabilitation unit and discharge from rehabilitation unit (typically 2-3 weeks) No

Sponsors