Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients

April 17, 2018 updated by: Gal Ifergane MD, Soroka University Medical Center

This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation.

The study will enroll 140 subjects which will be randomized into one of two arms:

  • Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge.
  • Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients eligible to be enrolled in this study are patients admitted to the Department of Neurology due to acute ischemic stroke up to 72 hours from the start of the stroke symptoms.

After receiving written informed consent from the patient, patients will be randomized into the intervention and control groups (1:1). The intervention group will be tested for sleep apnea and C-PAP treatment will be initiated during the initial hospitalization. The control group will receive standard medical care. Control group patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.

All subjects:

  • At the baseline, physical examination MRS and NIHSS will be performed by the neurologist.
  • Sleep testing at the baseline with mobile sleep lab device (Watch PAT)
  • Four questionnaires will be administered for all patients: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), quality of life (SF36), depression scale (Beck).
  • Blood sample will be taken for CRP, TNF-alpha, IL-6 and IL1 beta, VEGF, HBA1C, LDL and markers of endothelial dysfunction. These blood tests will be repeated at 3 and 6 months.
  • At discharge from the Neurology Department, 3 months and 6 months all patients will undergo NIHSS assessment.
  • Patients will be referred to the Soroka stroke clinic with rehabilitation program.
  • All patients will undergo 3 brain MRI scans, at baseline hospitalization, 3 and 6 months after.

Intervention group:

  • In the intervention group, the mobile sleep lab device (Watch PAT) will be used to identify patients with sleep apnea.
  • Treatment phase: Patients with (apnea hypopnea index) AHI≥15 will receive an in-hospital treatment with CPAP and continue CPAP treatment following discharge. The CPAP parameters will be titrated during the hospital stay.

Control group:

  • Patients will receive standard medical care. At three months, patients will undergo home sleep test with Watch-PAT device.
  • Patients with (apnea hypopnea index) AHI≥15 will receive CPAP treatment with titration at home.

TRIAL PROCEDURES 1. Patients eligible to be enrolled in this study are patients admitted to the Neurology Department due to stroke up to 72 hours after the showing of stroke symptoms.

2. At the baseline, physical examination, MRS and NIHSS will be performed by one of the Neurology Department doctors.

3. After receiving written informed consent from the patient, patients will be divided into 2 groups. Study group will have detection and treatment in 72 hours after stroke. Control group will have detection and treatment 3 months after stroke.

STUDY AND CONTROL GROUP

  1. The patient will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
  2. Next, the mobile sleep lab device (Watch PAT) will be placed on the patient's finger which will provide the apnea-hypopnea Index (AHI) and respiratory disturbance index (RDI).
  3. Blood samples for circulating inflammatory biomarkers and endothelial dysfunction will be performed in the morning. Four tubes of peripheral venous blood will be drawn. Every study patient will be tested for the presence of pro-inflammatory state. Specifically, the investigators will measure the presence of high sensitive C Reactive Protein (CRP) and centrifuged sera will be tested (by ultra- sensitive ELISA), for levels of circulating TNF-alpha, IL-6 and IL1 beta. Sera will also be tested for vascular endothelial growth factor (VEGF) and markers of endothelial dysfunction; P-selectin. LDL, HBA1C.
  4. At discharge from the Neurology Department, the patient will undergo NIHSS assessment.
  5. Half of patients randomly chosen will be asked to join an "early treatment" group for 6 months of C-PAP treatment. Patients from the other half will be asked for C-PAP treatment at 3 months (late intervention).
  6. All four questionnaires will be completed by all patients at the end of the follow up period.
  7. MRI scan will be done at three points: CVA admission, 3 and 6 months after.
  8. Six months after baseline hospitalization, patients from both groups will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients over the age of 18.
  2. Admitted to the Neurology Department due to acute ischemic stroke.
  3. Able to sign informed consent.
  4. Admission NIHSS 6-12.

Exclusion Criteria:

  1. Stroke symptom onset more than 72 hours prior to the enrollment
  2. Transient Ischemic Attack.
  3. Chronic pulmonary disease requiring home oxygen treatment.
  4. History of C-PAP treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Investigatory 1
The sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months.
Device: Watchpat
WatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea.
Device: CPAP
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own.
Experimental: Investigatory 2
The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months.
Device: Watchpat
WatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea.
Device: CPAP
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NIHSS change from the baseline to 3 months
Time Frame: 3 months
Change in the NIHSS score from admission to three months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
NIHSS change score from admission to discharge from the Neurology Department.
Time Frame: 3 months
3 months
NIHSS score change from admission to 6 months following hospitalization
Time Frame: 6 months
6 months
NIHSS score change from three to six months following hospitalization
Time Frame: 6 month
6 month
Prevent recurrent strokes at 6 months
Time Frame: 6 months
6 months
Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)
Time Frame: 6 months
6 months
Evaluate new MRI ischemic lesions between 3 MRI scans.
Time Frame: 6 months
6 months
Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline
Time Frame: 6 months
6 months
Change quality of life (SF36) at 3 and 6 months from the baseline
Time Frame: 6 months
6 months
Change depression scale (Beck) at 3 and 6 months from the baseline
Time Frame: 6 months
6 months
Change number of severe adverse events (SAE) at 3 months
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOR-0305-14-ctil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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