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

This study is currently recruiting participants.
Verified March 2014 by 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: March 31, 2014
Last verified: March 2014
  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 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 75
Study Start Date: March 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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
Genders Eligible for Study:   Both
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
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

No publications provided

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: March 31, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014