Obstructive Sleep ApneaNCT00205543
Study of Effects of Sutures on Results of Palate Surgery for Obstructive Sleep Apnea
A study testing uvulopalatopharyngoplasty with or without sutures in people with Obstructive Sleep Apnea, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- uvulopalatopharyngoplasty with or without sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sleep-study documented obstructive sleep apnea
- sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
- age > 21
Who cannot join
- previous palate surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Otolaryngology - Head & Neck Surgery, Virginia Commonwealth University
Richmond, Virginia, 23298-0146
About this study
Official title: Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes
In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.
Read the detailed description
Uvulopalatopharyngoplasty, or UPPP, is the most common surgical procedure performed for the treatment of obstructive sleep apnea. The procedure involves removal of redundant tissue from the lower palate (roof of mouth), including the uvula, and then suturing the cut edges of the remaining tissue together. However it is frequently noted by surgeons that sutures placed in the roof of the mouth do not stay intact. Also, in standard tonsillectomy, which involves removal of the tonsils and thus creation of a wound near the palate, no suturing is used, which does not seem to affect how the area heals. Previous studies have shown no significant differences in complication rates, post-operative pain, or symptom outcomes in patients undergoing tonsillectomy either with or without suture repair of the tonsillectomy wound. In this study we will examine whether suture repair following UPPP has any effect on post-operative pain, healing, or treatment success in terms of symptom resolution or post-operative sleep study results.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- uvulopalatopharyngoplasty with or without sutures
- Keywords
- obstructive sleep apnea, airway obstruction, sleep-disordered breathing
- Medical subject headings
- Sleep Apnea, Obstructive, Airway Obstruction, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uvulopalatopharyngoplasty with or without suturesProcedure or surgery
standard UPPP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | suture palate after resection Receives: Procedure: uvulopalatopharyngoplasty with or without sutures |
| 2 | Experimental | suture one side of palate afer resection Receives: Procedure: uvulopalatopharyngoplasty with or without sutures |
| 3 | Experimental | no sutures in palate after resection Receives: Procedure: uvulopalatopharyngoplasty with or without sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months
Measured: 6-12mo
Secondary outcomes (2)
Operative time
Measured: immediate
Procedure cost
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan R Reiter, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205543
- Sponsor's protocol ID
- 03802
- Status last verified
- Jun 2012
- First submitted
- 15 Sep 2005
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes
- ClinicalTrials.gov ID
- NCT00205543
- Acronym / sponsor ID
- 03802
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, airway obstruction, sleep-disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.
Detailed description
Uvulopalatopharyngoplasty, or UPPP, is the most common surgical procedure performed for the treatment of obstructive sleep apnea. The procedure involves removal of redundant tissue from the lower palate (roof of mouth), including the uvula, and then suturing the cut edges of the remaining tissue together. However it is frequently noted by surgeons that sutures placed in the roof of the mouth do not stay intact. Also, in standard tonsillectomy, which involves removal of the tonsils and thus creation of a wound near the palate, no suturing is used, which does not seem to affect how the area heals. Previous studies have shown no significant differences in complication rates, post-operative pain, or symptom outcomes in patients undergoing tonsillectomy either with or without suture repair of the tonsillectomy wound. In this study we will examine whether suture repair following UPPP has any effect on post-operative pain, healing, or treatment success in terms of symptom resolution or post-operative sleep study results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: uvulopalatopharyngoplasty with or without suturessuture palate after resection |
| 2 | Experimental | Procedure: uvulopalatopharyngoplasty with or without suturessuture one side of palate afer resection |
| 3 | Experimental | Procedure: uvulopalatopharyngoplasty with or without suturesno sutures in palate after resection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sleep-study documented obstructive sleep apnea
- sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
- age > 21
Key exclusion criteria (1 listed)
- previous palate surgery
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 |
|---|---|---|
| uvulopalatopharyngoplasty with or without suturesstandard UPPP | Procedure or surgery | 1, 2, 3 |
Primary outcome
sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months
Time frame: 6-12mo
2 secondary outcomes
Operative time
Time frame: immediate
Procedure cost
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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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.
Evan R Reiter, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uvulopalatopharyngoplasty with or without sutures in people with Obstructive Sleep Apnea, run by Virginia Commonwealth University 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 1 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: finished, as of the sponsor's last update on 21 Jun 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months (time frame: 6-12mo). 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 21 Jun 2012.