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
Qualifiers
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
Treatments tested in this trial
- Tonsillectomy
- Tonsillotomy
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Turku University Hospital
Lead sponsor
Tampere University Hospital
Collaborator
Oulu University Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov