• CLEVELAND, OHIO
  • 1-866-UH4-CARE
  • |
  • Search UH Online
Patients and Visitors Clinical Trials Listing
Print this pageEmail this pageBookmark Page

In This Section
For information or to register for screening in a selected trial, call HealthMatch (216) 844-5000

How to enroll

Search the listing of clinical trials below. When you find one which is appropriate for you click more information and you can apply by contacting us directly by phone or by online application form.
Clinical Trials

A Clinical Trial is a research study to answer specific questions about new therapies or new ways of using established treatments. Clinical Trials are used to determine whether new drugs or treatments are both safe and effective. Most current drug therapies were initially developed in past Clinical Trials.

Participants include men, women and children of all ages, races, religions and ethnic backgrounds, depending on the study guidelines. Protection of the rights, safety and welfare of our research participants is always our primary concern. Clinical Trial participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Each Clinical Trial is approved by the Institutional Review Board consisting of healthcare professionals as well as lay people from the community to ensure that risks are monitored and federal regulations are followed.

What follows is a brochure of some of the hundreds of Clinical Trials at University Hospitals of Cleveland that are actively recruiting participants. If you would like to participate, please note that each trial is listed with study-specific contact information. You may also enroll online by selecting the "Enroll in Clinical Trials" link at the left of this screen.

We hope you find this brochure useful, and that you will share it with friends and family who may benefit from one of the studies.

Nathan Levitan, MD
Chief Medical Officer
University Hospitals of Cleveland
Find a Clinical Trial

Trial Name:

HomePAP Study
Intro:

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches [home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management.
Condition:
Description:

Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches [home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.

Start Date - February 2008
End Date- December 2009
Criteria:

Intermediate to high probability of having OSA based on an adjusted neck circumference > 43 cm (17 inches) which will be determined by a Sleep Medicine Specialists during sleep consultation and the presence of excessive daytime sleepiness (Epworth sleepiness scale 12)

Exclusion Criteria:

  • Severe chronic insomnia, other condition with < 4 hrs of sleep per night
  • Unstable medical conditions
  • Major psychiatric diagnosis
  • Unable to undergo home testing
  • Concerns about unsafe driving
  • Severe COPD or restrictive lung disease
  • Chronic narcotic use
  • Alcohol abuse
  • History of cataplexy
  • Moderate to severe restless legs syndrome symptoms
  • Pre-existing diagnosis of sleep apnea
  • Prior experience with positive airway pressure treatment of sleep apnea
  • Anticipated upper airway surgery or gastric bypass surgery in 4 months
  • Decisional impairment for consenting
  • Hypoventilation syndrome, identified in the medical record
  • Waking oxygen saturation < 92%
Contact: For More Information, please contact Carol L. Rosen, MD at (216) 844-3267 - carol.rosen@case.edu or Rawan Salem at (216) 844-6278 - rawan.nawabit@case.edu

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

Fill out the form below to request more information about this clinical trial:

First Name:
Middle Name:
Last Name:
Address 1:
Address 2:
City:
State:
Zip / Postal Code:
Country:
Daytime Phone:
Evening Phone:
Email Address:
Back