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

NCT07580170 | Not Yet Recruiting

• 1 other identifier: VARHA/28047/13.02.02/2025
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

sleep apnea; tonsillectomy; tonsillotomy; intracapsular tonsillectomy; adults; tonsil hypertrophy

Outcome Measures

Primary Outcomes (1)

• Changes in AHI at baseline and after surgery

  The primary outcome is changes in AHI measured with home sleep study

  baseline, 4-6, 24 and 60 months after surgery.

Secondary Outcomes (5)

• Daytime sleepiness

  Baseline and 6, 12, 24 and 60 months after surgery

• Changes in insomnia symptoms

  Baseline and 6, 12, 24 and 60 months after surgery

• Surgical success rate

  Baseline and 6, 12, 24 and 60 months after surgery

• Surgical cure rate

  Baseline and 6, 12, 24 and 60 months after surgery

• Changes in nocturnal desaturation

  Before surgery and 4-6, 24 and 60 months after surgery

Study Arms (2)

Tonsillectomy

ACTIVE COMPARATOR

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. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon.

Procedure: Tonsillectomy

Tonsillotomy

ACTIVE COMPARATOR

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. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon.

Procedure: Tonsillotomy

Interventions

Tonsillectomy PROCEDURE

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.

Tonsillectomy

Tonsillotomy PROCEDURE

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.

Tonsillotomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Turku University Hospital: lead
• Oulu University Hospital: collaborator
• Helsinki University Central Hospital: collaborator
• Tampere University Hospital: collaborator

Study Sites (4)

Helsinki University Hospital

Helsinki, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jaakko M Piitulainen, MD, PhD

  Turku University Hospital

  STUDY DIRECTOR

• Henrik Sjöblom, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Jenny Knubb, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaakko M Piitulainen, MD, PhD

CONTACT

+35823130000; jaakko.piitulainen@utu.fi

Henrik Sjöblom, MD

CONTACT

+35823130000; henrik.sjoblom@varha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of surgical intervention, surgeon and care providers in the operation theatre are not blinded to treatment allocation. Trial participants, outcome assessors, and data analysts are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Tonsil surgery is performed while patient is under general anesthesia by experienced otorhinolaryngologist who are familiar with both techniques (a minimum of 20 procedures performed using each technique). 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. 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. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon.

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2036
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Study protocol and Statistical Analysis Plan at the Beginning will be published at Clinical Trials.gov before the enrolment has started.
• Access Criteria: Open access

Locations

FI (4)