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Is your CPAP Therapy a Problem? If so, you may be eligible to participate in this research study on oral appliances to treat obstructive sleep apnea (OSA) & snoring. Texas A&M University College of Dentistry researchers are conducting a study to compare two of the leading oral appliance designs in improving sleep quality, airway function & snoring. Why are we doing this research? This research study is being conducted to identify which oral appliance is best accepted by patients & is highly effective in OSA management. OSA can be a serious health problem beyond the snoring that disturbs your bed partner. It can contribute to daytime sleepiness, unsafe driving, high blood pressure, heart disease & other chronic health conditions. Eligibility: If you at least 18 years old, diagnosed with moderate or severe OSA, have a recent overnight sleep study, use continuous positive airway pressure (CPAP), but are dissatisfied with your CPAP therapy, you may qualify to participate in this study. Requirements: The study is 9-weeks long and requires regular visits to the TAMU College of Dentistry, 3302 Gaston Avenue, Dallas, TX. The study involves doing home sleep tests for at least 4 nights, & wearing an oral appliance at night for 8 weeks. Benefits, Risks & Compensation: Potential benefits include reduction of OSA & snoring; improved sleep quality. Potential risks & discomforts are minimal. No financial compensation will be provided to you, but you will be able to keep the two custom- made oral appliances at the completion of the study. There is no cost to you to participate. Study Title: Midline traction versus bilateral thrust oral appliances: A randomized controlled trial to determine superiority for improving upper airway function and sleep quality. Principal Investigators: Dr. Emet Schneiderman, Dept. of Biomedical Sciences [email protected], Dr. Steven Bender, DDS, Director, Facial Pain & Sleep Clinic, [email protected] Funded by: The Baylor Oral Health Foundation and Airway management Inc. Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] Study coordinator 214-828-8291 [email protected] For more information, contact the Study Coordinator, Ms. Zohre German at 214-828-8291 or [email protected] IRB NUMBER: 2017-0390-CD-FB IRB APPROVAL DATE: 01/25/2018 IRB EXPIRATION DATE: 08/15/2018

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Page 1: Is your CPAP Therapy a Problem? appliances to … › clinical-affairs › clinical...OSA can be a serious health problem beyond the snoring that disturbs your bed partner. It can

Is your CPAP Therapy a Problem?If so, you may be eligible to participate in this research study on oral appliances to treat obstructive sleep apnea (OSA) & snoring.

Texas A&M University College of Dentistry researchers are conducting a study to compare two of the leading oral appliance designs in improving sleep quality, airway function & snoring.

Why are we doing this research? This research study is being conducted to identify which oral appliance is best accepted by patients & is highly effective in OSA management.

OSA can be a serious health problem beyond the snoring that disturbs your bed partner. It can contribute to daytime sleepiness, unsafe driving, high blood pressure, heart disease & other chronic health conditions.

Eligibility: If you at least 18 years old, diagnosed with moderate or severe OSA, have a recent overnight sleep study, use continuous positive airway pressure (CPAP), but are dissatisfied with your CPAP therapy, you may qualify to participate in this study.

Requirements: The study is 9-weeks long and requires regular visits to the TAMU College of Dentistry, 3302 Gaston Avenue, Dallas, TX. The study involves doing home sleep tests for at least 4 nights, & wearing an oral appliance at night for 8 weeks.

Benefits, Risks & Compensation: Potential benefits include reduction of OSA & snoring; improved sleep quality. Potential risks & discomforts are minimal. No financial compensation will be provided to you, but you will be able to keep the two custom-made oral appliances at the completion of the study. There is no cost to you to participate.

Study Title: Midline traction versus bilateral thrust oral appliances: A randomized controlled trial to determine superiority for improving upper airway function and sleep quality.

Principal Investigators: Dr. Emet Schneiderman, Dept. of Biomedical Sciences [email protected], Dr. Steven Bender, DDS, Director, Facial Pain & Sleep Clinic, [email protected]

Funded by: The Baylor Oral Health Foundation and Airway management Inc.

TAMU DATE-STAMP GOES HERE

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

Study coordinator 214-828-8291germ

an@tam

hsc.edu

For more information, contact the Study Coordinator, Ms. Zohre German at 214-828-8291 or [email protected]

IRB NUMBER: 2017-0390-CD-FBIRB APPROVAL DATE: 01/25/2018IRB EXPIRATION DATE: 08/15/2018