Back to resultsIntracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Primary Purpose
Tonsillar Hypertrophy, Sleep Apnea, Obstructive
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Tonsillectomy
Sponsored by
About this trial
This is an interventional treatment trial for Tonsillar Hypertrophy focused on measuring tonsil surgery, tonsillectomy, obstructive sleep apnea, coblation, intracapsular
Eligibility Criteria
Inclusion Criteria:
- age 16-64
- Planned tonsil surgery with informed concent
- Obstructive sleep apnea (AHI > 15)
- Tonsillar size of 3-4 on the Friedman scale
Exclusion Criteria:
- BMI > 35 (Based on finnish Käypä Hoito -recommendations)
- Central sleep apnea
- Weight loss of more than 10% within the study period
- Untreated obstruction of nasal breathing
- Treated peritonsillar abscess <1 month before enrollment
- Active tonsillar infection
- Previous tonsillar surgery (excluding incision of abscess)
- Malignancy
- High use of analgesics >1 DDD daily during last 4 weeks
- Untreated reflux
- Anticoagulative medication
- Any condition of hemophilia
- Pregnancy, lactation
- Other, evaluated by treating physician
Sites / Locations
- Satasairaala
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intracapsular tonsillectomy with coblation
Arm Description
(Total) Intracapsular tonsillectomy (ICTE) with coblation
Outcomes
Primary Outcome Measures
Apnea-hypopnea index
Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.
Secondary Outcome Measures
Quality of life measured by Glasgow Benefit Inventory
General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Quality of life measured by Nordic tonsil surgery register questionnaire
Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score.
Quality of life measured by Epworth sleepiness scale
Questions regarding sleepiness. Score 0-24, lower is better.
Post-operative recovery
Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory.
Total recovery of obstructive sleep apnea
Defined by apnea-hypopnea index <5 post-operatively in polysomnography.
Regrowth of tonsillar tissue
Measured by photography, Friedman scale (0-4, lower is smaller).
Apnea-index
Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.
Snoring time
Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in
Full Information
NCT ID
NCT04314492
First Posted
March 13, 2020
Last Updated
October 18, 2022
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04314492
Brief Title
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Official Title
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation
Detailed Description
The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillar Hypertrophy, Sleep Apnea, Obstructive
Keywords
tonsil surgery, tonsillectomy, obstructive sleep apnea, coblation, intracapsular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracapsular tonsillectomy with coblation
Arm Type
Experimental
Arm Description
(Total) Intracapsular tonsillectomy (ICTE) with coblation
Intervention Type
Procedure
Intervention Name(s)
Tonsillectomy
Intervention Description
Intracapsular removal of tonsillar tissue (>90%) with coblation
Primary Outcome Measure Information:
Title
Apnea-hypopnea index
Description
Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life measured by Glasgow Benefit Inventory
Description
General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.
Time Frame
6 months
Title
Quality of life measured by Nordic tonsil surgery register questionnaire
Description
Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score.
Time Frame
6 months - up to 5 years
Title
Quality of life measured by Epworth sleepiness scale
Description
Questions regarding sleepiness. Score 0-24, lower is better.
Time Frame
6 months - up to 5 years
Title
Post-operative recovery
Description
Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory.
Time Frame
21 days
Title
Total recovery of obstructive sleep apnea
Description
Defined by apnea-hypopnea index <5 post-operatively in polysomnography.
Time Frame
6 months and 24 months
Title
Regrowth of tonsillar tissue
Description
Measured by photography, Friedman scale (0-4, lower is smaller).
Time Frame
Pre-operative to 6 months
Title
Apnea-index
Description
Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.
Time Frame
6 months and 24 months
Title
Snoring time
Description
Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in
Time Frame
6 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 16-64
Planned tonsil surgery with informed concent
Obstructive sleep apnea (AHI > 15)
Tonsillar size of 3-4 on the Friedman scale
Exclusion Criteria:
BMI > 35 (Based on finnish Käypä Hoito -recommendations)
Central sleep apnea
Weight loss of more than 10% within the study period
Untreated obstruction of nasal breathing
Treated peritonsillar abscess <1 month before enrollment
Active tonsillar infection
Previous tonsillar surgery (excluding incision of abscess)
Malignancy
High use of analgesics >1 DDD daily during last 4 weeks
Untreated reflux
Anticoagulative medication
Any condition of hemophilia
Pregnancy, lactation
Other, evaluated by treating physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik M. Sjöblom, M.D.
Phone
023130000
Ext
+358
Email
hmsjob@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jaakko Piitulainen, M.D., Ph.D.
Phone
023130000
Ext
+358
Email
jaakko.piitulainen@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jussi Jero, Professor
Organizational Affiliation
University of Turku
Official's Role
Study Director
Facility Information:
Facility Name
Satasairaala
City
Pori
State/Province
Satakunta
ZIP/Postal Code
28500
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilia Mikola, M.D:
Phone
02 627 71
Facility Name
Turku University Hospital
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaakko Piitulainen, MD, PhD
Phone
02 313 0000
Email
jaakko.piitulainen@tyks.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
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