Sleep Apnea, ObstructivePhase 4NCT00380458
Study to Evaluate Recovery From Postoperative Pain After Sleep Apnea Surgery
A Phase 4 study testing Coblation (radiofrequency-based device) in people with Sleep Apnea, Obstructive, run by ArthroCare Corporation at 1 site in United States.
Trial summary
The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Coblation (radiofrequency-based device)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > or = 18 years of age
- Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
- Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
- Subject signs IRB-approved informed consent form
- Subject is willing and able to complete required follow-up.
Who cannot join
- Subject has had a previous tonsillectomy
- Subject's RDI >40
- Subject has a history of chronic use of narcotic pain medications
- Subject is unable to take liquid opioid analgesics
- Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Controlled Clinical Trial to Evaluate Recovery From Post-operative Pain in Adults After Sleep Apnea Surgery Using a Coblation Device Compared to Electrocautery
The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection.
Read the detailed description
This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using the study device to treat OSA symptoms in an adult population is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. The amount of post-operative pain will be assessed daily over the 21-day post-operative recovery period using two general measures: 1) self-reported pain intensity and 2) self-reported pain medication administration, including frequency of use and dose. Further, timing of self-medication will be analyzed separately.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Coblation (radiofrequency-based device)
- Keywords
- Obstructive, Sleep, Apnea, Pain, UPPP, Tonsillectomy, Narcotics
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coblation (radiofrequency-based device)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
Secondary outcomes (3)
Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
Analysis of timing of self-administration of medication during the 21-day post-treatment period
Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
Why it stopped: No patients enrolled. Study did not start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Investigators
- John Bitner, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380458
- Sponsor's protocol ID
- E-0406JM
- Status last verified
- Aug 2015
- First submitted
- 22 Sep 2006
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Troell RJ, Powell NB, Riley RW, Li KK, Guilleminault C. Comparison of postoperative pain between laser-assisted uvulopalatoplasty, uvulopalatopharyngoplasty, and radiofrequency volumetric tissue reduction of the palate. Otolaryngol Head Neck Surg. 2000 Mar;122(3):402-9. doi: 10.1016/S0194-5998(00)70056-8.
PubMed 10699818Quinn SJ, Daly N, Ellis PD. Observation of the mechanism of snoring using sleep nasendoscopy. Clin Otolaryngol Allied Sci. 1995 Aug;20(4):360-4. doi: 10.1111/j.1365-2273.1995.tb00061.x.
PubMed 8548973Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. doi: 10.1093/sleep/19.2.156.
PubMed 8855039Sher AE. An overview of sleep disordered breathing for the otolaryngologist. Ear Nose Throat J. 1999 Sep;78(9):694-5, 698-700, 703-6 passim.
PubMed 10502892
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Controlled Clinical Trial to Evaluate Recovery From Post-operative Pain in Adults After Sleep Apnea Surgery Using a Coblation Device Compared to Electrocautery
- ClinicalTrials.gov ID
- NCT00380458
- Acronym / sponsor ID
- E-0406JM
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive, Sleep, Apnea, Pain, UPPP, Tonsillectomy, Narcotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled. Study did not start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Collaborators
- Mayo Clinic
- First posted
- 26 Sep 2006 (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.
The purpose of this study is to assess whether tonsillectomy and UPPP performed using the study device to treat Obstructive Sleep Apnea (OSA) symptoms in adults is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection.
Detailed description
This prospective clinical study is designed to assess whether tonsillectomy and UPPP performed using the study device to treat OSA symptoms in an adult population is associated with less postoperative pain during the 21-day postoperative recovery period compared to electrocautery dissection. The amount of post-operative pain will be assessed daily over the 21-day post-operative recovery period using two general measures: 1) self-reported pain intensity and 2) self-reported pain medication administration, including frequency of use and dose. Further, timing of self-medication will be analyzed separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is > or = 18 years of age
- Subject has positive diagnosis of Obstructive Sleep Apnea confirmed by polysomnographic study
- Subject is a surgical candidate for UPPP and tonsillectomy with or without tongue base somnoplasty
- Subject signs IRB-approved informed consent form
- Subject is willing and able to complete required follow-up.
Key exclusion criteria (5 listed)
- Subject has had a previous tonsillectomy
- Subject's RDI >40
- Subject has a history of chronic use of narcotic pain medications
- Subject is unable to take liquid opioid analgesics
- Subject requires additional surgical procedures (such as nasal septoplasty or FESS) within 28 days of enrollment
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 |
|---|---|---|
| Coblation (radiofrequency-based device) | Device | – |
Primary outcome
Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.
3 secondary outcomes
Number of days to pain resolution as measured using a visual analogue scale during the 21-day post-treatment period.
Analysis of timing of self-administration of medication during the 21-day post-treatment period
Analysis of daily pain intensity using a visual analogue scale during the 21-day post-treatment period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 10699818Troell RJ, Powell NB, Riley RW, Li KK, Guilleminault C. Comparison of postoperative pain between laser-assisted uvulopalatoplasty, uvulopalatopharyngoplasty, and radiofrequency volumetric tissue reduction of the palate. Otolaryngol Head Neck Surg. 2000 Mar;122(3):402-9. doi: 10.1016/S0194-5998(00)70056-8.
- Background: PubMed 8548973Quinn SJ, Daly N, Ellis PD. Observation of the mechanism of snoring using sleep nasendoscopy. Clin Otolaryngol Allied Sci. 1995 Aug;20(4):360-4. doi: 10.1111/j.1365-2273.1995.tb00061.x.
- Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Background: PubMed 8855039Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. doi: 10.1093/sleep/19.2.156.
- Background: PubMed 10502892Sher AE. An overview of sleep disordered breathing for the otolaryngologist. Ear Nose Throat J. 1999 Sep;78(9):694-5, 698-700, 703-6 passim.
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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.
John Bitner, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coblation (radiofrequency-based device) in people with Sleep Apnea, Obstructive, run by ArthroCare Corporation 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Aug 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of days to cessation of narcotic pain medication use during the 21-day post-treatment period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00380458, which also lists 5 linked publications.
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 26 Aug 2015.