Sleep for Stroke Management and Recovery Trial (Sleep SMART)

March 29, 2024 updated by: Devin L. Brown, MD, University of Michigan
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Study Type

Interventional

Enrollment (Estimated)

3062

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Hospital
        • Contact:
        • Principal Investigator:
          • Soo Young Kwon, MD
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center Phoenix
        • Principal Investigator:
          • Joyce Lee Lannotti, MD
        • Contact:
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Dignity Health - St. Joseph's Hospital and Medical Center
        • Principal Investigator:
          • Supreet Kaur, MD
        • Contact:
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • TMC HealthCare
        • Principal Investigator:
          • David Teeple, MD
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner- University Medical Center Tucson
        • Contact:
        • Principal Investigator:
          • Firas Kaddouh, MD
    • California
      • Carmichael, California, United States, 95608
      • Downey, California, United States, 90242
        • Recruiting
        • Rancho Los Amigos National Rehabilitation Center
        • Contact:
        • Principal Investigator:
          • Susan Shaw, MD
      • La Jolla, California, United States, 92103
        • Recruiting
        • UCSD Health La Jolla
        • Contact:
        • Principal Investigator:
          • Dawn Meyer, PhD
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Konrad Schlick, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Principal Investigator:
          • Alon Avidan, MD
        • Contact:
      • Los Angeles, California, United States, 94612
        • Recruiting
        • Kaiser Permanente Los Angeles
        • Contact:
        • Principal Investigator:
          • Prasanth Manthena, MD
      • Modesto, California, United States, 95355
      • Ontario, California, United States, 91761
        • Recruiting
        • UCLA Kaiser Fontana
        • Principal Investigator:
          • Conrad Liang, MD
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine
        • Contact:
        • Principal Investigator:
          • Masaki Nagamine, MD
      • Pomona, California, United States, 91767
        • Recruiting
        • Casa Colina
        • Principal Investigator:
          • Caroline Schnakers, PhD
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
        • Principal Investigator:
          • Kwan Ng, MD
        • Contact:
      • San Diego, California, United States, 92103
        • Recruiting
        • UCSD Medical Center - Hillcrest Hospital
        • Contact:
        • Principal Investigator:
          • Dawn Meyer, PhD
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Helen Diller Medical Center at Parnassus Heights
        • Principal Investigator:
          • Wade Smith, MD, PhD
        • Contact:
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Orange County Global Medical Center
        • Contact:
        • Principal Investigator:
          • John Chen, MD
      • Sylmar, California, United States, 91342
        • Not yet recruiting
        • Olive View- UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Neal Rao, MD
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • John Muir Medical Center- Walnut Creek Campus
        • Contact:
        • Principal Investigator:
          • Ok-Kyung Kim, MD
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • St. Mary's Hospital and Medical Center
        • Principal Investigator:
          • Logan Mcdaneld, MD
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital
        • Contact:
        • Principal Investigator:
          • Klar Yaggi, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University Hospital
        • Contact:
        • Principal Investigator:
          • Fernando Mayor Basto, MD
    • Florida
      • Gainesville, Florida, United States, 32611
      • Jacksonville, Florida, United States, 32216
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jose Romano, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Hospital of Miami
        • Contact:
        • Principal Investigator:
          • Felipe De Los Rios La Rosa, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital
        • Contact:
        • Principal Investigator:
          • Jose Romano, MD
      • Sarasota, Florida, United States, 34239
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Contact:
        • Principal Investigator:
          • William Scott Burgin, MD
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Not yet recruiting
        • Grady Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Mark Hinrichs, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Laurel Cherian, MD
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
        • Principal Investigator:
          • Kenneth Lee, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Hospital and Health Sciences System
        • Contact:
        • Principal Investigator:
          • Gabriela Trifan, MD
      • Peoria, Illinois, United States, 61603
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Memorial Medical Center
        • Contact:
        • Principal Investigator:
          • Hesham Allam, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Mark Dyken, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40218
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center - Main Campus
        • Principal Investigator:
          • Richard Zweifler, MD
        • Contact:
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • University Health Shreveport
        • Principal Investigator:
          • Oleg Chernyshev, MD, PhD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Seemant Chaturvedi, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Milena Pavlova, MD
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Aneesh Singhal, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Jennifer Dearborn-Tomazos, MD
      • Boston, Massachusetts, United States, 02111
      • Springfield, Massachusetts, United States, 01199
      • Worcester, Massachusetts, United States, 01655
        • Not yet recruiting
        • UMass Memorial Medical Center,
        • Principal Investigator:
          • Brian Silver, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Principal Investigator:
          • Angelos Katramados, MD
        • Contact:
      • Flint, Michigan, United States, 48532
        • Recruiting
        • McLaren Flint
        • Principal Investigator:
          • Mahmoud Rayes, MD
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
      • Kalamazoo, Michigan, United States, 49008
        • Recruiting
        • Bronson Methodist Hospital
        • Principal Investigator:
          • Mark Goetting, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Saint Marys Campus
        • Principal Investigator:
          • Eugene Scharf, MD
        • Contact:
      • Saint Cloud, Minnesota, United States, 56303
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Kunal Bhatia, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:
        • Principal Investigator:
          • Karin Olds, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-jewish Hospital
        • Principal Investigator:
          • Eric Landsness, MD
        • Contact:
      • Springfield, Missouri, United States, 65807
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Pierre Fayad, MD
        • Contact:
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Not yet recruiting
        • JFK Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • Divya Gupta, MD
      • Neptune, New Jersey, United States, 07753
        • Not yet recruiting
        • Hackensack Meridian Jersey Shore University Medical Center
        • Principal Investigator:
          • Sanskriti Mishra, MD
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Hospital
        • Contact:
        • Principal Investigator:
          • Omar Hussein, MD
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Kathryn Kirchoff-Torres, MD
        • Contact:
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Medical Center
        • Contact:
        • Principal Investigator:
          • Qingliang Wang, MD
      • Brooklyn, New York, United States, 11220
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Medical Center
        • Contact:
        • Principal Investigator:
          • Amit Kandal, MD
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Contact:
        • Principal Investigator:
          • Rohan Arora, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone -Tish Hospital Medical Center
        • Principal Investigator:
          • Koto Ishida, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • NYP Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Joshua Willey, MD, MS
      • Rochester, New York, United States, 14642
      • Staten Island, New York, United States, 10305
        • Recruiting
        • Staten Island University Hospital
        • Principal Investigator:
          • Umran Ugur, MD
        • Contact:
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
        • Principal Investigator:
          • Julius Gene Latorre, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center Atrium Health
        • Principal Investigator:
          • Rahul Karamchandani, MD
        • Contact:
      • Concord, North Carolina, United States, 28025
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Guilford Neurologic Associates, Inc
        • Principal Investigator:
          • Pramod Sethi, MD
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • Cheryl Bushnell, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Principal Investigator:
          • Natalie Kreitzer, MD
        • Contact:
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Christ Hospital
        • Principal Investigator:
          • Karthik Kanagarajan, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Zeshaun Khawaja, MD
        • Contact:
      • Cleveland, Ohio, United States, 11100
        • Recruiting
        • UH Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Sophia Sundararajan, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • OSU Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Sushil Lakhani, MD
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • West Chester Hospital
        • Principal Investigator:
          • Natalie Kreitzer, MD
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • St. John Health System
        • Principal Investigator:
          • Rahul Rahangdale, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Principal Investigator:
          • Biggya Sapkota, MD
        • Contact:
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Hospital Bethlehem Campus
        • Principal Investigator:
          • Daniel Ackerman, MD
        • Contact:
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Clinic
        • Principal Investigator:
          • Clemens Schirmer, MD
        • Contact:
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Steven Messe, MD
      • Philadelphia, Pennsylvania, United States, 19122
        • Recruiting
        • Temple University Hospital
        • Contact:
        • Principal Investigator:
          • Michael Mullen, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian Hospital
        • Principal Investigator:
          • Sarah Wondisford, MD
        • Contact:
    • South Carolina
      • Columbia, South Carolina, United States, 29203
      • Greenville, South Carolina, United States, 29605
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Avera Research Institute
        • Contact:
        • Principal Investigator:
          • William Rossing, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • Methodist University
        • Contact:
        • Principal Investigator:
          • Balaji Krishnaiah, MD
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Institute of Rehabilitation
        • Principal Investigator:
          • Chad Swank, MD
        • Contact:
      • Houston, Texas, United States, 77030
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Paul Johnson, MD
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Healthcare
        • Contact:
        • Principal Investigator:
          • Jana Wold, MD
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • The University of Vermont Medical Center Main Campus
        • Principal Investigator:
          • Christopher Commichau, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • UVA Medical Center
        • Principal Investigator:
          • Nina Solenski, MD
        • Contact:
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax
        • Contact:
        • Principal Investigator:
          • Saqib Chaudhry, MD
    • Washington
      • Seattle, Washington, United States, 98101
      • Seattle, Washington, United States, 98195
        • Recruiting
        • Harborview Medical Center
        • Contact:
        • Principal Investigator:
          • Sandeep Khot, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • Ruby Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Mouhannad Azzouz, MD
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Foundation
        • Contact:
        • Principal Investigator:
          • Mark Domroese, MD
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • University of Wisconsin University Hospital
        • Contact:
        • Principal Investigator:
          • Robert Dempsey, MD

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. TIA with ABCD2 ≥4 or ischemic stroke, within the prior 14 days.

Exclusion Criteria:

  1. pre-event inability to perform all of own basic ADLs
  2. unable to obtain informed consent from subject or legally authorized representative
  3. incarcerated
  4. known pregnancy
  5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy
  6. current use of positive airway pressure, or use within one month prior to stroke
  7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
  8. severe bullous lung disease
  9. history of prior spontaneous pneumothorax or current pneumothorax
  10. hypotension requiring current treatment with pressors (can enroll later if this resolves)
  11. other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
  12. massive epistaxis or previous history of massive epistaxis
  13. cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
  14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
  15. current receipt of oxygen supplementation >4 liters per minute
  16. current contact, droplet, respiratory/airborne precautions

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm: CPAP with Usual Care.
6 months of CPAP plus usual medical therapy.
Device: CPAP
Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
No Intervention: Control Arm: Usual Care.
6 months of usual medical therapy alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Event Combined Outcome: new ischemic stroke, acute coronary syndrome, or all-cause mortality
Time Frame: 6 months post randomization
The primary outcome is a time-to-event outcome defined as a participant having at least one of the following events within 6-months from randomization: new ischemic stroke, acute coronary syndrome or all-cause mortality
6 months post randomization
Modified Rankin Scale Score
Time Frame: 3 months post randomization
Functional outcome as measured by the 9 question modified Rankin Scale (mRS-9Q). The mRS-9Q has 9 questions related to level of function. Outcomes range from 0 (no symptoms) to 6 (death).
3 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIH Stroke Score (NIHSS)
Time Frame: 3 months post randomization
Neurological outcome is measured by the NIHSS. The NIHSS scale ranges from 0 (no deficits) to 42.
3 months post randomization
Short Montreal Cognitive Assessment (MoCA) Score
Time Frame: 3 months post randomization
Cognitive outcome is measured by the Short MoCA. The short MoCA is a 5 minute short version of the Montreal Cognitive Assessment (MoCA). This instrument tests phonemic verbal fluency (1 point), delayed recall (5 points), and orientation (6 points) with a score ranging from 0-12.
3 months post randomization
Quality of Life outcome
Time Frame: 3 months post randomization
Quality of life outcome is measured by the shortened Stroke Specific Quality of Life Scale (SS-QOL). The short SS-QOL has 7 domains that include physical function, language, vision, thinking, energy, mood, and role function. There is 1 question from each domain. The 12 item SS-QOL is calculated by averaging the scores of these 12 questions.
3 months post randomization

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

Medical University of South Carolina
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
FusionHealth LLC

Investigators

  • Principal Investigator: Devin Brown, MD, MS, University of Michigan
  • Principal Investigator: Ronald Chervin, MD, MS, University of Michigan

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 (Actual)

May 9, 2019

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00147316
  • 1U01NS099043-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will comply with the NIH Data Sharing Policy, Policy on the Dissemination of NIH-Funded Clinical Trial Information, the Clinical Trials Registration and Results Information Submission rule, and StrokeNet SOP on Network Data Sharing Policy. NDMC statisticians will generate data files from each data table and in compliance with HIPAA regulations each table will be de-identified. A minimum number of derived variables necessary to reproduce the primary analysis will be created. Within a year from acceptance of the primary manuscript or no later than two years from database lock, the public-use data sets will be submitted to the NINDS data repository along with final version of the study protocol, data dictionary and a user guide. Data along with signals from sleep apnea recordings will be submitted to the NHLBI National Sleep Research Resource.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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