Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Conditions
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.
Detailed description
Obstructive sleep apnea hypopnea syndrome (OSAHS) is a major public health problem, and studies suggest that the incidence of OSAHS may be even higher than estimated. Transoral base of tongue resections are commonly preformed to improve symptoms in OSAHS, but among surgeons there is not yet consensus as to the best tongue base operation. The difficulty in treating the tongue base is illustrated by the abundance of available procedures - including genioglossus advancement, hyoid advancement, tongue base suspension, radiofrequency treatment, transoral midline glossesctomy, submucosal coblation-assisted tongue base resection and recently; transoral robotic-assisted surgery (TORS) for base of tongue (BOT) resection. We will evaluate TORS BOT resection for use in OSAHS by assessing pre- and post-operative OSAHS scores and comparing them to historical data for alternative BOT operations. Though routine, BOT resection may result in significant post-operative pain leading to dysphagia. In certain patients, major complications such as aspiration pneumonia, malnutrition and dehydration can occur as a result. Thus, reducing post-operative dysphagia is critical to improving patient outcomes and limiting complication-associated hospital admissions. Several studies have addressed the management of post-operative dysphagia, but none have evaluated TORS BOT resections in OSAHS. Additionally, TORS BOT resections for malignant neoplasms have been previously shownto be safe and feasible. An outcome analysis of TORS BOT resections for OSAHS may therefore yield recommendations for reducing patient morbidity and mortality.
Interventions
PROCEDURETransoral Robotic Surgery
Base of tongue resection with transoral robotic-assisted surgery (TORS).
Sponsors
University of Alabama at Birmingham
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Any patient with documented OSAHS who is scheduled for tongue base resection at UAB 2. Age \> 18 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Apnea Hypopnea Index (AHI) Score | Baseline, 3 months, 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transoral BOT Participants who received transoral base of tongue surgery as treatment for OASHS. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Transoral BOT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Number of Participants Stratified by Apnea Hypopnea Index (AHI) score Mild apnea (AHI score of 0 to 14.99) | 8 participants |
| Number of Participants Stratified by Apnea Hypopnea Index (AHI) score Moderate apnea (AHI score of 15 to 29.99) | 5 participants |
| Number of Participants Stratified by Apnea Hypopnea Index (AHI) score no recorded AHI score available | 11 participants |
| Number of Participants Stratified by Apnea Hypopnea Index (AHI) score Severe apnea (AHI score of 30 or higher) | 17 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 4 / 41 |
| serious Total, serious adverse events | 2 / 41 |
Outcome results
Primary
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.
Time frame: Baseline, 3 months, 6 months
Population: Participant attrition rate was very high; no data were collected.