Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children

Obstructive Sleep Apnea Clinical Trial

Official title:

Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00694772
• Other study ID #: E-21417
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2008
• Last updated: June 9, 2008
• Start date: June 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2008
• Source: University of Calgary
• Contact: Derek S Drummond, MD, MPH
• Phone: (403) 955-2218
• Email: dsdrummond[@]shaw.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Electrocautery-tonsillectomy
standard of care electrocautery tonsillectomy
• Coblation-tonsillotomy
use of Arthrocare Coblation Technology to perform tonsillotomy

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Calgary	ArthroCare Corporation, Calgary Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		6 months and 2 years post-op	No
Secondary	Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy		1 week post-op	No
Secondary	Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA		6-8 weeks post-op	No