Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS

NCT01107795 | Terminated Results

• 1 other identifier: F091104002
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Outcome Measures

Primary Outcomes (1)

• Improvement in Apnea Hypopnea Index (AHI) Score

  Improvement in Apnea Hypopnea Index (AHI) score, as measured by a polysomnogram sleep study. The AHI score is the number of apnea events per hour, with a lower score indicating mild sleep apnea and a higher score indicating severe sleep apnea. An improved AHI score would be a lower score at 6 months than at 3 months and baseline.

  Baseline, 3 months, 6 months

Interventions

Transoral Robotic Surgery PROCEDURE

Base of tongue resection with transoral robotic-assisted surgery (TORS).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Any patient with documented OSAHS who is scheduled for tongue base resection at UAB
• Age \> 18
• Patients must sign informed consent

You may not qualify if:

• Psychological condition that renders the patient unable to understand the informed consent
• Any situation or condition that will interfere with adherence to study activities

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Results Point of Contact

• Title: Dr. Kirk Withrow
• Organization: University of Alabama at Birmingham

kwithrow@uabmc.edu

(205) 801-7874

Study Officials

• Kirk Withrow, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 21, 2010
• Study Start: March 4, 2010
• Primary Completion: May 28, 2019
• Study Completion: July 26, 2019
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Locations

US (1)