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

NCT07580170 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-12

No results posted yet for this study

Summary

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.

Conditions

  • Sleep Apnea, Obstructives
  • Tonsil Hypertrophy

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.

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Jaakko M Piitulainen, MD, PhD · Turku University Hospital

  • Henrik Sjöblom, MD · Turku University Hospital

  • Jenny Knubb, MD · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2031-01-01
Completion
2036-01-01

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07580170 on ClinicalTrials.gov