The Recovery in Stroke Using PAP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset;
- •Being within 5 days of neurologic symptoms onset;
- •Moderate (15 =< overall AHI < 30) /severe (overall AHI >= 30) OSA, thus with an obstructive apnea-hypopnea index AHI >= 15.
排除标准
- •Past use of prescribed PAP for OSA;
- •Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory);
- •Life expectancy is less than 6 months (e.g., hospice patients);
- •Patients who require mechanical ventilation (because such patients could not participate in the intervention protocol);
- •Non-English language patients (because the intervention strategy involves forming a relationship between the patient and research staff);
- •Central sleep apnea with > 50% of respiratory events classified as central apnea;
- •Resting oxygen saturation < 90%.
- •Inability to provide their own informed consent. To enhance the generalizability of our study, all stroke severity will be included. However, we will exclude patients who cannot provide their own consent. This is because patients will need to participate actively in the protocol with a behavioral intervention. An assessment of the patient's competence to provide consent will be made based on published recommendations.
研究组 & 干预措施
PAP treatment- Acute
Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
干预措施: PAP (Device)
PAP treatment- Acute
Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
干预措施: HLE (Behavioral)
Usual Care (HLE)
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
干预措施: HLE (Behavioral)
PAP treatment- Subacute
Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
干预措施: PAP (Device)
PAP treatment- Subacute
Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support.
All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.
干预措施: HLE (Behavioral)
Exploratory arm
Non-randomized comparison/exploratory group of subjects with ischemic stroke and Apnea-Hypopnea Index (AHI) <15 (approximately 120 participants) and approximately 60 subjects with ICH (who do not need legally authorized representative for consent - most likely mild form of ICH) and any level of AHI.
干预措施: HLE (Behavioral)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 6 months
The Modified Rankin Scale is a widely used measure of functional status and is sensitive to the full range of impairment from mild to severe. This objective examination scale with be video recorded by field staff and subsequently scored by the study neurologist blinded to randomization arm. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. The higher the score, the more severe the disability. A score of 6 indicates the patient has expired (during the hospital stay or after discharge from the hospital).
Change in Katz Scale
时间窗: Randomization date, 3 months, 6 months
The Katz Index of Independence in Activities of Daily Living (KatzADL), is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform Activities of Daily Living independently. The Index ranks adequacy of performance in the 6 functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the 6 functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment
次要结局
- Medical Outcomes Survey-Short Form 36 (MOS-SF36)(6 months)
- Patient Health Questionnaire-8 (PHQ-8)(6 months)
- Montreal Cognitive Assessment (MoCA)(6 months)
- NIH Stroke Scale (NIHSS)(3 months)
- Epworth Sleepiness Scale (ESS)(6 months)
- Stroke Specific Quality of Life (SS-QOL)(6 months)
- The Calgary Sleep Apnea Quality of Life Index (SAQLI)(6 months)
- Formative Adherence Evaluation(3 months)
- Change in Berg Balance Scale(3 and 6 months)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Randomization date, 3 months, 6 months)
- Change in Insomnia Severity Index (ISI) Severity Index(Randomization date, 3 months, 6 months)
- Change in PROMIS Pain Interference - Short Form 6b V1.0(Randomization date, 3 months, 6 months)
- Change in PROMIS Pain Intensity - Short Form 3a V1.0(Randomization date, 3 months, 6 months)
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8a(day 7)
- Change in PROMIS Short Form v1.0 Sleep-Related Impairment 8a(day 7)
- NIH Stroke Scale (NIHSS)(3 months)
- Epworth Sleepiness Scale (ESS)(6 months)
- Medical Outcomes Survey-Short Form 36 (MOS-SF36)(6 months)
- Patient Health Questionnaire-8 (PHQ-8)(6 months)
- Montreal Cognitive Assessment (MoCA)(6 months)
- Stroke Specific Quality of Life (SS-QOL)(6 months)
- The Calgary Sleep Apnea Quality of Life Index (SAQLI)(6 months)
- Formative Adherence Evaluation(3 months)
- Change in Berg Balance Scale(3 and 6 months)
- Fall Events(Up to 6 months)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Randomization date, 3 months, 6 months)
- Change in Insomnia Severity Index (ISI) Severity Index(Randomization date, 3 months, 6 months)
- Change in PROMIS Pain Interference - Short Form 6b V1.0(Randomization date, 3 months, 6 months)
- Change in PROMIS Pain Intensity - Short Form 3a V1.0(Randomization date, 3 months, 6 months)
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8a(day 7)
- Change in PROMIS Short Form v1.0 Sleep-Related Impairment 8a(day 7)
- NIH Stroke Scale (NIHSS)(1 month)