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Prospective Study to Evaluate Outcomes From Trans-oral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Kirk P. Withrow, MD, University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Kirk P. Withrow, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01107795
First received: April 8, 2010
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
This is a prospective observational study that will collect outcome data for patients who choose to undergo transoral tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)as part of their standard of care treatment. This is a data collection study only and does not provide for evaluations or treatment of OSAHS.

Condition Intervention
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Procedure: Transoral Robotic Surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study to Evaluate Outcomes From Trans-oral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome

Resource links provided by NLM:


Further study details as provided by Kirk P. Withrow, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • Base of tongue resection with transoral robotic-assisted surgery yields improvements in OSAHS. [ Time Frame: After accrual objectives are met ]

Secondary Outcome Measures:
  • Post-operative pain. [ Time Frame: 2- 4 weeks, 3 months and 6 months post surgery ]
  • Post-operative complications. [ Time Frame: Reviewed monthly ]
  • Difficulty swallowing. [ Time Frame: 2-4 weeks, 3 months and 6 months post surgery ]

Estimated Enrollment: 75
Study Start Date: March 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transoral Robotic Surgery
    Base of tongue resection with transoral robotic-assisted surgery (TORS).
  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who choose to undergo transoral robotic assisted tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).
Criteria

Inclusion Criteria:

  1. Any patient with documented OSAHS who is scheduled for tongue base resection at UAB
  2. Age > 19
  3. Patients must sign informed consent

Exclusion Criteria:

  1. Psychological condition that renders the patient unable to understand the informed consent
  2. Any situation or condition that will interfere with adherence to study activities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107795

Contacts
Contact: Lisa Clemons, RN, MSN lclemons@uab.edu

Locations
United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Kirk Withrow, MD University of Alabama at Birmingham
  More Information

Responsible Party: Kirk P. Withrow, MD, Assistant Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01107795     History of Changes
Other Study ID Numbers: F091104002
Study First Received: April 8, 2010
Last Updated: August 29, 2016

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 25, 2017