Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils (TONOS)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jaakko M Piitulainen, MD, PhD
- Telefonnummer: +35823130000
- E-post: jaakko.piitulainen@utu.fi
Studera Kontakt Backup
- Namn: Henrik Sjöblom, MD
- Telefonnummer: +35823130000
- E-post: henrik.sjoblom@varha.fi
Studieorter
-
-
-
Helsinki, Finland
- Helsinki University Hospital
-
Kontakt:
- Johanna Ruohoalho, MD, PhD
- Telefonnummer: +35894711
- E-post: firstname.lastname@hus.fi
-
Kontakt:
- Vanhapiha Nelli, MD
-
Oulu, Finland
- Oulu University Hospital
-
Kontakt:
- Aleksi Laajala, MD
- Telefonnummer: +35886699500
- E-post: firstname.lastname@oulu.fi
-
Kontakt:
- Alakärppä Antti, MD, PhD
-
Tampere, Finland
- Tampere University Hospital
-
Kontakt:
- Saara Markkanen, MD, PhD
- Telefonnummer: +3583311611
- E-post: firstname.lastname@pirha.fi
-
Kontakt:
- Saara Lesonen, MD
-
Turku, Finland
- Turku University Hospital
-
Kontakt:
- Henrik M Sjöblom, MD
- Telefonnummer: +35823130000
- E-post: hmsjob@utu.fi
-
Kontakt:
- Jenny Knubb, MD
- Telefonnummer: +35823130000
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon. |
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.
|
|
Aktiv komparator: 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. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon. |
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in AHI at baseline and after surgery
Tidsram: baseline, 4-6, 24 and 60 months after surgery.
|
The primary outcome is changes in AHI measured with home sleep study
|
baseline, 4-6, 24 and 60 months after surgery.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Daytime sleepiness
Tidsram: Baseline and 6, 12, 24 and 60 months after surgery
|
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
Tidsram: Baseline and 6, 12, 24 and 60 months after surgery
|
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
Tidsram: Baseline and 6, 12, 24 and 60 months after surgery
|
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
|
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Surgical cure rate
Tidsram: Baseline and 6, 12, 24 and 60 months after surgery
|
Defined as a total AHI of <5 after surgery
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Baseline and 6, 12, 24 and 60 months after surgery
|
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Changes in nocturnal desaturation
Tidsram: Before surgery and 4-6, 24 and 60 months after surgery
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Jaakko M Piitulainen, MD, PhD, Turku University Hospital
- Huvudutredare: Henrik Sjöblom, MD, Turku University Hospital
- Huvudutredare: Jenny Knubb, MD, Turku University Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VARHA/28047/13.02.02/2025
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IPD-planbeskrivning
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IPD-delning som stöder informationstyp
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