Stroke and CPAP Outcome Study 2

NCT ID: NCT02809430

Last Updated: 2020-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-07-31

Brief Summary

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 enrolled eligible stroke patients undergoing inpatient rehabilitation (IPR) into an intensive CPAP adherence protocol (iCAP) with an aim to increase tolerance and adherence to auto-titrating CPAP (APAP).

Detailed Description

The SCOUTS (Stroke and CPAP Outcome Study 2) was a single-arm, open-label study performed at 2 IPR units of the University of Washington. Eligible stroke patients undergoing IPR were provided an intensive CPAP adherence protocol (iCAP) to increase tolerance and adherence to auto-titrating CPAP (APAP). The iCAP included 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-- defined as participant willingness to continue APAP during IPR and over the 3-month treatment period. If both criteria were met, APAP treatment with iCAP continued during the rehabilitation stay and over a 3-month period. The goal of the intervention was to achieve 50% of subjects meeting APAP adherence (an average ≥ 4 hours per night) over the 3-month treatment period. The investigators evaluated if demographic, co-morbid or stroke-specific factors predicted APAP adherence and assessed the relationship between APAP adherence and neurological recovery from stroke.

Conditions

Sleep Apnea, Obstructive; Stroke; Patient Adherence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP intervention

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.

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure

Intervention Type: DEVICE

Auto-titrating Continuous Positive Airway Pressure (APAP) among patients admitted to a rehabilitation unit after ischemic or hemorrhagic stroke for 3 month treatment period.

Interventions

Continuous Positive Airway Pressure

Auto-titrating Continuous Positive Airway Pressure (APAP) among patients admitted to a rehabilitation unit after ischemic or hemorrhagic stroke for 3 month treatment period.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients admitted after acute ischemic or hemorrhagic stroke to one of two inpatient rehabilitation units

Exclusion Criteria

• The investigators will exclude participants if: their stroke was a subarachnoid hemorrhage or due to a secondary cause (vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding); they have active CPAP use, advanced chronic lung disease requiring supplemental oxygen, heart failure (NYHA class III or IV); or they needed a nasogastric feeding tube.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Sandeep Khot

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandeep Khot, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

Khot S, Barnett H, Davis A, Siv J, Crane D, Kunze A, Li Lue D, Bunnell A, McCann B, Bombardier C, Longstreth WT Jr, Watson N, Billings M. Intensive Continuous Positive Airway Pressure Adherence Program During Stroke Rehabilitation. Stroke. 2019 Jul;50(7):1895-1897. doi: 10.1161/STROKEAHA.119.024795. Epub 2019 May 20.

Reference Type: RESULT

PMID: 31104619 (View on PubMed)

Khot SP, Barnett HM, Davis AP, Byun E, McCann BS, Bombardier CH, Rappisi K, Longstreth WT Jr, Billings ME, Brown DL, Garrison MM. Novel and modifiable factors associated with adherence to continuous positive airway pressure therapy initiated during stroke rehabilitation: An exploratory analysis of a prospective cohort study. Sleep Med. 2022 Sep;97:43-46. doi: 10.1016/j.sleep.2022.05.013. Epub 2022 May 26.

Reference Type: DERIVED

PMID: 35716543 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

43428A

Identifier Type: -

Identifier Source: org_study_id