Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTurku University Hospital
About this trial
The aim is to investigate whether the tissue-preserving tonsil surgery technique is as effective as complete tonsil removal in the treatment of obstructive sleep apnea. The primary outcome measure is the change in the apnea-hypopnea index (AHI) before surgery and at 4-6, 24, and 60 months after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BMI < 35
Tonsil size 2 - 4
Otherwise healthy patient fit for tonsil surgery
Apnea-hypopnea index > 15
Disqualifiers
Pathological hemostasis or use of anticoagulation
Craniofacial deformities
Neurological condition with muscular hypotonia
Other surgical treatment for OSA
Trial design
Design model
Parallel
Treatments tested in this trial
Tonsillectomy
Procedure/SurgeryTE will be performed by dissection in the peritonsillar plane. Parts of the upper and lateral palatal mucosal arches will be incised, and an extracapsular dissection for complete tonsil excision will be performed.
Tonsillotomy
Procedure/SurgeryTT will be performed by removing approximately 60 - 90% of the tonsillar tissue, leaving a rim of tonsillar tissue on the tonsillar fossae. The tonsil capsule will not be breached.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: TonsillectomyActive comparator 1 intervention
Group B: TonsillotomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in AHI at baseline and after surgery
The primary outcome is changes in AHI measured with home sleep study
Time frame
baseline, 4-6, 24 and 60 months after surgery.Secondary outcomes
1
Daytime sleepiness
Measured with Epworth Sleepiness Scale (ESS) questionnaire (patient-reported). Points 0-18, higher is worse.
Time frame
Baseline and 6, 12, 24 and 60 months after surgery2
Changes in insomnia symptoms
Measured with Insomnia Severity Index (ISI) questionnaire, points range 0-28, higher is worse.
Time frame
Baseline and 6, 12, 24 and 60 months after surgery3
Surgical success rate
Defined according to Sher's criteria: a reduction in AHI of \>50% and a total AHI of \<20 after surgery
Time frame
Baseline and 6, 12, 24 and 60 months after surgery4
Surgical cure rate
Defined as a total AHI of \<5 after surgery
Time frame
Baseline and 6, 12, 24 and 60 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
Tampere University Hospital
Collaborator
Oulu University Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov
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