Stroke and CPAP Outcome Study 2

NCT02809430 | Completed Results

• 1 other identifier: 43428A
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Apnea, Obstructive; Stroke; Patient Adherence

Outcome Measures

Primary Outcomes (1)

• 3-month CPAP Adherence

  Number of participants who continue CPAP after the run-in period who have acceptable adherence at 3 months, defined as using CPAP for an average of at least 4 hours a night on at least 70% of nights.

  3 months

Secondary Outcomes (4)

• CPAP Tolerance

  Upon discharge from rehabilitation unit, typically at 14-21 days from CPAP initiation

• Change in the Cognitive Functional Independence Measure (FIM) Subscore

  Between admission to rehabilitation unit and between 3-4 months following enrollment

• Change in the Motor Functional Independence Measure (FIM) Subscore

  Between admission to rehabilitation unit and between 3-4 months following enrollment

• Change in NIH Stroke Scale

  NIHSS scores were obtained in-person on enrollment and at 90 ± 7 days from enrollment.

Study Arms (1)

CPAP intervention

EXPERIMENTAL

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.

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure 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.

CPAP intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195-9470, United States

Location

Related Publications (2)

• 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.

  PMID: 31104619 RESULT

• 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.

  PMID: 35716543 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Stroke; Patient Compliance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Sandeep Khot
• Organization: University of Washington

skhot@uw.edu

206-744-3251

Study Officials

• Sandeep Khot, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 22, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 23, 2020
• Results First Posted: December 23, 2020

Record last verified: 2020-11

Locations

US (1)