Menu
Not yet recruiting NCT07580170

Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils

No phase Interventional Sleep Apnea, Obstructives Tonsil Hypertrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tonsillectomy, Tonsillotomy.
Who it may be relevant to
Registry conditions: Sleep Apnea, Obstructives, Tonsil Hypertrophy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter, National, Randomized, Patient-Blinded, Parallel Group, Non-Inferiority Trial To Compare Tonsillotomy Versus Extracapsular Tonsillectomy in Adults With Obstructive Sleep Apnea and Tonsil Hypertrophy: The TONOS Trial.

Overview

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.

Detailed description

Adult reviews suggest tonsillotomy (TT) reduces morbidity compared to tonsillectomy (TE). In pediatric populations, the effectiveness of partial tonsil surgery for sleep apnea (OSA) is well-documented. It remains unclear if TT is non-inferior to TE in adults in the treatment of OSA. This study compares TE with TT in adults using change in apnea-hypopnea index as the primary endpoint.

The hypothesis is that TT is non-inferior compared to TE in treating patients with moderate or severe OSA and grade 2 to 4 tonsil size.

Participants are blinded to the allocated intervention with an allocation ratio 1:1. Participants will be recruited from patients referred to an outpatient hospital clinic. The trial will be carried out in four tertiary hospitals in Finland.

Interventions

  • Procedure Tonsillectomy
    TE 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.
  • Procedure Tonsillotomy
    TT 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.

Primary outcome measures

  • Changes in AHI at baseline and after surgery [Time frame: baseline, 4-6, 24 and 60 months after surgery.]
Secondary outcome measures (5)
  • Daytime sleepiness [Time frame: Baseline and 6, 12, 24 and 60 months after surgery]
  • Changes in insomnia symptoms [Time frame: Baseline and 6, 12, 24 and 60 months after surgery]
  • Surgical success rate [Time frame: Baseline and 6, 12, 24 and 60 months after surgery]
  • Surgical cure rate [Time frame: Baseline and 6, 12, 24 and 60 months after surgery]
  • Changes in nocturnal desaturation [Time frame: Before surgery and 4-6, 24 and 60 months after surgery]

Eligibility criteria

Inclusion criteria

  • BMI < 35
  • Tonsil size 2 - 4
  • Otherwise healthy patient fit for tonsil surgery
  • Apnea-hypopnea index > 15
  • Obstructive sleep apnea symptoms

Exclusion criteria

  • Pathological hemostasis or use of anticoagulation
  • Craniofacial deformities
  • Neurological condition with muscular hypotonia
  • Other surgical treatment for OSA

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Finland · 4 centers
  • Helsinki University Hospital — Helsinki
  • Oulu University Hospital — Oulu
  • Tampere University Hospital — Tampere
  • Turku University Hospital — Turku

Identifiers

NCT: NCT07580170 · VARHA/28047/13.02.02/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗