Your session is about to expire
← Back to Search
Sleep Apnea Intervention for Stroke (ASAP Trial)
N/A
Waitlist Available
Led By Jason Sico, MD MHS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured throughout active implementation and sustainability periods
Awards & highlights
ASAP Trial Summary
This trial will improve rates of testing and treating for obstructive sleep apnea (OSA) in stroke and TIA patients, which will in turn improve patient outcomes and reduce hospital readmissions.
Who is the study for?
This trial is for patients who've had a stroke or TIA (mini-stroke) and haven't been diagnosed with sleep apnea. Participating facilities must admit over 50 such cases yearly and have dedicated staff for system redesign. Patients in palliative care, unable to use PAP therapy, or with contraindications to PAP are excluded.Check my eligibility
What is being tested?
The ASAP study tests a Quality Improvement Protocol aimed at increasing the diagnosis and treatment of obstructive sleep apnea (OSA) in stroke/TIA survivors across six VA Medical Centers, evaluating its effect on OSA management and recurrence of vascular events.See study design
What are the potential side effects?
Since this trial focuses on improving healthcare practices rather than testing drugs, it does not directly involve medication side effects. However, any interventions as part of quality improvement may carry risks which will be monitored by the healthcare team.
ASAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured throughout active implementation and sustainability periods
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured throughout active implementation and sustainability periods
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Facility-level OSA diagnostic rate
Secondary outcome measures
Facility-level all-cause readmission rate
Facility-level recurrent vascular event rate
Facility-level treatment rate
+1 moreOther outcome measures
Audit and Feedback
External Facilitation
Implementation Outcome - Adaptation
+2 moreASAP Trial Design
3Treatment groups
Experimental Treatment
Group I: Active implementation - Wave 3 (Fifth and Sixth Sites)Experimental Treatment1 Intervention
This four-year stepped-wedge evaluation includes a total of 6 sites. Active implementation is initiated in 3 waves, each of which includes 2 sites. The project involves two phases at each of the 6 sites: a variable number of 7-month data periods during baseline period (three 7-month periods for Wave 1 sites, four 7-month data periods for Wave 2 sites, five 7-month data periods for Wave 3 sites), three 7-month data periods in active implementation phase for each wave. Wave 1 and Wave 2 sites will also each have one 7-month period of sustainability. The stepped-wedge design allows for 6 mutually exclusive, 7-month data periods. The baseline data period is the time prior to the date of the baseline site visit. The active implementation data period extends 21 months after the site visit. The stepped-wedge design allows site-level estimates of proportions on six different cross-sectional samples. Investigators will have repeated information on each site. "Arm" 3 corresponds to Wave 3.
Group II: Active implementation - Wave 2 (Third and Fourth Sites)Experimental Treatment1 Intervention
This four-year stepped-wedge evaluation includes a total of 6 sites. Active implementation is initiated in 3 waves, each of which includes 2 sites. The project involves two phases at each of the 6 sites: a variable number of 7-month data periods during baseline period (three 7-month periods for Wave 1 sites, four 7-month data periods for Wave 2 sites, five 7-month data periods for Wave 3 sites), three 7-month data periods in active implementation phase for each wave. Wave 1 and Wave 2 sites will also each have one 7-month period of sustainability. The stepped-wedge design allows for 6 mutually exclusive, 7-month data periods. The baseline data period is the time prior to the date of the baseline site visit. The active implementation data period extends 21 months after the site visit. The stepped-wedge design allows site-level estimates of proportions on six different cross-sectional samples. Investigators will have repeated information on each site. "Arm" 2 corresponds to Wave 2.
Group III: Active implementation - Wave 1 (First and Second Sites)Experimental Treatment1 Intervention
This four-year stepped-wedge evaluation includes a total of 6 sites. Active implementation is initiated in 3 waves, each of which includes 2 sites. The project involves two phases at each of the 6 sites: a variable number of 7-month data periods during baseline period (three 7-month periods for Wave 1 sites, four 7-month data periods for Wave 2 sites, five 7-month data periods for Wave 3 sites), three 7-month data periods in active implementation phase for each wave. Wave 1 and Wave 2 sites will also each have one 7-month period of sustainability. The stepped-wedge design allows for 6 mutually exclusive, 7-month data periods. The baseline data period is the time prior to the date of the baseline site visit. The active implementation data period extends 21 months after the site visit. The stepped-wedge design allows site-level estimates of proportions on six different cross-sectional samples. Investigators will have repeated information on each site. "Arm" 1 corresponds to Wave 1.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,597 Total Patients Enrolled
1 Trials studying Ischemic Stroke
174 Patients Enrolled for Ischemic Stroke
Jason Sico, MD MHSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
Jason Jonathon Sico, MD MHSPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My care facility admits over 50 stroke/TIA patients yearly and has staff for system redesign.My care facility admits fewer than 50 stroke/TIA patients yearly and lacks dedicated staff for system redesign.I have had a stroke or TIA and have not been diagnosed with sleep apnea.I am not in hospice care and can use PAP therapy without issues like facial injuries or trouble clearing secretions.
Research Study Groups:
This trial has the following groups:- Group 1: Active implementation - Wave 2 (Third and Fourth Sites)
- Group 2: Active implementation - Wave 3 (Fifth and Sixth Sites)
- Group 3: Active implementation - Wave 1 (First and Second Sites)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment ongoing for this clinical investigation?
"The data on clinicaltrials.gov reveals that this medical study is no longer actively recruiting patients, having first been posted on April 2nd 2020 and last updated June 29th 2022. While participation in the trial has closed, there are currently 1601 other trials accepting participants."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger