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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| Oulu University Hospital | OTHER |
| Helsinki University Central Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daytime sleepiness | Measured with Epworth Sleepiness Scale (ESS) questionnaire (patient-reported). Points 0-18, higher is worse. | Baseline and 6, 12, 24 and 60 months after surgery |
| Changes in insomnia symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaakko M Piitulainen, MD, PhD | Contact | +35823130000 | jaakko.piitulainen@utu.fi | |
| Henrik Sjöblom, MD | Contact | +35823130000 | henrik.sjoblom@varha.fi |
| Name | Affiliation | Role |
|---|---|---|
| Jaakko M Piitulainen, MD, PhD | Turku University Hospital | Study Director |
| Henrik Sjöblom, MD | Turku University Hospital | Principal Investigator |
| Jenny Knubb, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Finland |
Data dictionary describing the variables.
Study protocol and Statistical Analysis Plan at the Beginning will be published at Clinical Trials.gov before the enrolment has started.
Open access
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 23, 2026 | May 31, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 4, 2025 | May 31, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D014068 | Tonsillectomy |
| ID | Term |
|---|---|
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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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.
| 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. |
|
Measured with Insomnia Severity Index (ISI) questionnaire, points range 0-28, higher is worse.
| Baseline and 6, 12, 24 and 60 months after surgery |
| Surgical success rate | Defined according to Sher's criteria: a reduction in AHI of >50% and a total AHI of <20 after surgery | Baseline and 6, 12, 24 and 60 months after surgery |
| Surgical cure rate | Defined as a total AHI of <5 after surgery | Baseline and 6, 12, 24 and 60 months after surgery |
| Changes in nocturnal desaturation | Changes in nocturnal desaturation measured with oxygen saturation (SaO2) mean, min, and SpO2 <90% (T90) and ODI3, measured with home sleep study | Before surgery and 4-6, 24 and 60 months after surgery |
| Turku University Hospital |
| Principal Investigator |
| Oulu University Hospital | Oulu | Finland |
|
| Tampere University Hospital | Tampere | Finland |
|
| Turku University Hospital | Turku | Finland |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |