Obstructive Sleep ApneaNCT00694772
Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children
A study testing Electrocautery-tonsillectomy and Coblation-tonsillotomy in people with Obstructive Sleep Apnea, run by University of Calgary at 1 site in Canada.
Trial summary
Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Electrocautery-tonsillectomy and Coblation-tonsillotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Jun 2013
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Moderate or severe OSA on PSG (AHI ≥ 5.0)
- Pronounced tonsillar hyperplasia on physical exam
- No previous tonsil or adenoid surgery
- No history of recurrent tonsillitis
- Participants and their families must be willing to comply with follow-up
- Parents/caregivers fluent in English
Who cannot join
- Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Derek S Drummond, MD, MPH, (403) 955-2218, dsdrummond@shaw.ca
Derek S Drummond, MD, MPH
About this study
Official title: Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study
Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Electrocautery-tonsillectomy, Coblation-tonsillotomy
- Keywords
- Obstructive sleep apnea, OSA, Apnea hypopnea index, AHI, Coblation, Electrocautery, Tonsillectomy, Tonsillotomy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocautery-tonsillectomyProcedure or surgery
standard of care electrocautery tonsillectomy
Coblation-tonsillotomyProcedure or surgery
Also called alternative procedure name: subcapsular tonsillectomy
use of Arthrocare Coblation Technology to perform tonsillotomy
| Study group | Role | What they receive |
|---|---|---|
| Electrocautery | Active comparator | Not described Receives: Procedure: Electrocautery-tonsillectomy |
| Coblation | Experimental | Not described Receives: Procedure: Coblation-tonsillotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare coblation-tonsillotomy to electrocautery-tonsillectomy as a treatment of obstructive sleep apnea (OSA), as assessed by apnea-hypopnea index (AHI) measured on polysomnography (PSG)
Measured: 6 months and 2 years post-op
Secondary outcomes (2)
Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy
Measured: 1 week post-op
Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA
Measured: 6-8 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
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 University of CalgaryThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- ArthroCare Corporation, Calgary Health Region
- Investigators
- Derek S Drummond, MD, MPH, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694772
- Sponsor's protocol ID
- E-21417
- Status last verified
- Jun 2008
- First submitted
- 6 Jun 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study
- ClinicalTrials.gov ID
- NCT00694772
- Acronym / sponsor ID
- E-21417
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, OSA, Apnea hypopnea index, AHI, Coblation, Electrocautery, Tonsillectomy, Tonsillotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- ArthroCare Corporation, Calgary Health Region
- Study start
- Jun 2008
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 10 Jun 2008 (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.
Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrocautery | Active comparator | Procedure: Electrocautery-tonsillectomy |
| Coblation | Experimental | Procedure: Coblation-tonsillotomy |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Moderate or severe OSA on PSG (AHI ≥ 5.0)
- Pronounced tonsillar hyperplasia on physical exam
- No previous tonsil or adenoid surgery
- No history of recurrent tonsillitis
- Participants and their families must be willing to comply with follow-up
Key exclusion criteria (1 listed)
- Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay
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 |
|---|---|---|
| Electrocautery-tonsillectomystandard of care electrocautery tonsillectomy | Procedure or surgery | Electrocautery |
| Coblation-tonsillotomyAlso: alternative procedure name: subcapsular tonsillectomyuse of Arthrocare Coblation Technology to perform tonsillotomy | Procedure or surgery | Coblation |
Primary outcome
Compare coblation-tonsillotomy to electrocautery-tonsillectomy as a treatment of obstructive sleep apnea (OSA), as assessed by apnea-hypopnea index (AHI) measured on polysomnography (PSG)
Time frame: 6 months and 2 years post-op
2 secondary outcomes
Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy
Time frame: 1 week post-op
Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA
Time frame: 6-8 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
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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.
Derek S Drummond, MD, MPH principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocautery-tonsillectomy and Coblation-tonsillotomy in people with Obstructive Sleep Apnea, run by University of Calgary at 1 site in Canada.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Jun 2008. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derek S Drummond, MD, MPH ((403) 955-2218, dsdrummond@shaw.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare coblation-tonsillotomy to electrocautery-tonsillectomy as a treatment of obstructive sleep apnea (OSA), as assessed by apnea-hypopnea index (AHI) measured on polysomnography (PSG) (time frame: 6 months and 2 years post-op). 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 10 Jun 2008.