Clinical trial NCT04314492: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillar Hypertrophy
Sleep Apnea, Obstructive
Keywords: tonsil surgery
tonsillectomy
obstructive sleep apnea
coblation
intracapsular
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Apnea-hypopnea index
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life measured by Glasgow Benefit Inventory
timeFrame: 6 months and 24 month and 60 months
measure: Quality of life measured by Nordic tonsil surgery register questionnaire
timeFrame: 6 months - up to 5 years
measure: Quality of life measured by Epworth sleepiness scale
timeFrame: 6 months - up to 5 years
measure: Post-operative recovery
timeFrame: 21 days
measure: Total recovery of obstructive sleep apnea
timeFrame: 6 months and 24 months and 60 months
measure: Regrowth of tonsillar tissue
timeFrame: Pre-operative to 6 months
measure: Apnea-index
timeFrame: 6 months and 24 months and 60 months
measure: Snoring time
timeFrame: 6 months and 24 months and 60 months
Other outcomes:
measure: Apnea-hypopnea index
timeFrame: 24 months
measure: Apnea-hypopnea index
timeFrame: 60 months
Locations:
city: Pori
country: Finland
facility: Satasairaala
state: Satakunta
city: Turku
country: Finland
facility: Turku University Hospital
state: Varsinais-Suomi
Study officials:
affiliation: University of Turku
name: Jussi Jero, Professor
role: STUDY_DIRECTOR
affiliation: Turku University Hospital
name: Jaakko Piitulainen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: