Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT04130503
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Recovery in Stroke Using PAP Study
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
The Recovery in Stroke Using PAP Study
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE-UP
Brief Summary:
The proposed study is a randomized controlled trial among an anicipated 180 participants with acute ischemic stroke and mod/severe OSA diagnosed by ambulatory polysomnography (PSG) comparing PAP treatment with usual care concerning the primary outcome of functional recovery.
Detailed Description:
This study has 4 aims: 3 main aims and an additional exploratory aim.
Specific aim 1 or Aim A: Test whether PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke symptoms, post-stroke functional recovery (primary outcome), and quality of life.
Specific aim 2 or Aim D: Determine whether acute vs. subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life).
Specific Aim 3 or Aim B: Conduct in-depth qualitative interviews with 25-30 stroke patients, family members, and acute care providers to elicit their experience with PAP use, including factors that influence adherence.
Exploratory aim or Aim C: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.
With regard to projected recruitment scenarios, investigators will use an appropriate Aim scenario as described below:
In case of low post-randomization losses with symmetrical distribution between mild and no OSA/SAS (sleep apnea syndrome) and more severe OSA/SAS - Aims labeled with numbers will be used.
In case of high post randomization losses with asymmetrical distribution between mild and no OSA/SAS (sleep apnea syndrome) and more severe OSA/SAS - the same Aims labeled with letters will be used.
Specific aim 1 or Aim A: Test whether PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke symptoms, post-stroke functional recovery (primary outcome), and quality of life.
Specific aim 2 or Aim D: Determine whether acute vs. subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life).
Specific Aim 3 or Aim B: Conduct in-depth qualitative interviews with 25-30 stroke patients, family members, and acute care providers to elicit their experience with PAP use, including factors that influence adherence.
Exploratory aim or Aim C: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.
With regard to projected recruitment scenarios, investigators will use an appropriate Aim scenario as described below:
In case of low post-randomization losses with symmetrical distribution between mild and no OSA/SAS (sleep apnea syndrome) and more severe OSA/SAS - Aims labeled with numbers will be used.
In case of high post randomization losses with asymmetrical distribution between mild and no OSA/SAS (sleep apnea syndrome) and more severe OSA/SAS - the same Aims labeled with letters will be used.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01NR018335-01 | NIH | None | https://reporter.nih.gov/quic… | View |