Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)NCT01107795
Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS
An observational study of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS), run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
- What is being tested?
- Transoral Robotic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2010to 26 Jul 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who choose to undergo transoral robotic assisted tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).
Who may be able to join
- Any patient with documented OSAHS who is scheduled for tongue base resection at UAB
- Age > 18
- Patients must sign informed consent
Who cannot join
- Psychological condition that renders the patient unable to understand the informed consent
- Any situation or condition that will interfere with adherence to study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Prospective Study to Evaluate Outcomes From Transoral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome
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.
Read the 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.
- Being tested
- Transoral Robotic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Robotic SurgeryProcedure or surgery
Base of tongue resection with transoral robotic-assisted surgery (TORS).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study start4 Mar 2010
- Primary completion28 May 2019
- Study completion26 Jul 2019
Why it stopped: Participant attrition before final follow-up visit was greater than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirk P. Withrow, MD, University of Alabama at Birmingham
- Investigators
- Kirk Withrow, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107795
- Sponsor's protocol ID
- F091104002
- Status last verified
- Dec 2019
- First submitted
- 8 Apr 2010
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate Outcomes From Transoral Base of Tongue Resection for Obstructive Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT01107795
- Acronym / sponsor ID
- F091104002
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Participant attrition before final follow-up visit was greater than anticipated.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 4 Mar 2010 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who choose to undergo transoral robotic assisted tongue base operations for Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS).
Key inclusion criteria (3 listed)
- Any patient with documented OSAHS who is scheduled for tongue base resection at UAB
- Age > 18
- Patients must sign informed consent
Key exclusion criteria (2 listed)
- Psychological condition that renders the patient unable to understand the informed consent
- Any situation or condition that will interfere with adherence to study activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral Robotic SurgeryBase of tongue resection with transoral robotic-assisted surgery (TORS). | Procedure or surgery | – |
Primary outcome
Improvement in Apnea Hypopnea Index (AHI) Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk Withrow, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS), run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Apnea Hypopnea Index (AHI) Score (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.