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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jaakko M Piitulainen, MD, PhD
- Telefonnummer: +35823130000
- E-post: jaakko.piitulainen@utu.fi
Studer Kontakt Backup
- Navn: Henrik Sjöblom, MD
- Telefonnummer: +35823130000
- E-post: henrik.sjoblom@varha.fi
Studiesteder
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Helsinki, Finland
- Helsinki University Hospital
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Ta kontakt med:
- Johanna Ruohoalho, MD, PhD
- Telefonnummer: +35894711
- E-post: firstname.lastname@hus.fi
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Ta kontakt med:
- Vanhapiha Nelli, MD
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Oulu, Finland
- Oulu University Hospital
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Ta kontakt med:
- Aleksi Laajala, MD
- Telefonnummer: +35886699500
- E-post: firstname.lastname@oulu.fi
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Ta kontakt med:
- Alakärppä Antti, MD, PhD
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Tampere, Finland
- Tampere University Hospital
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Ta kontakt med:
- Saara Markkanen, MD, PhD
- Telefonnummer: +3583311611
- E-post: firstname.lastname@pirha.fi
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Ta kontakt med:
- Saara Lesonen, MD
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Turku, Finland
- Turku University Hospital
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Ta kontakt med:
- Henrik M Sjöblom, MD
- Telefonnummer: +35823130000
- E-post: hmsjob@utu.fi
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Ta kontakt med:
- Jenny Knubb, MD
- Telefonnummer: +35823130000
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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.
|
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in AHI at baseline and after surgery
Tidsramme: baseline, 4-6, 24 and 60 months after surgery.
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The primary outcome is changes in AHI measured with home sleep study
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baseline, 4-6, 24 and 60 months after surgery.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Daytime sleepiness
Tidsramme: Baseline and 6, 12, 24 and 60 months after surgery
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Measured with Epworth Sleepiness Scale (ESS) questionnaire (patient-reported).
Points 0-18, higher is worse.
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Baseline and 6, 12, 24 and 60 months after surgery
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Changes in insomnia symptoms
Tidsramme: Baseline and 6, 12, 24 and 60 months after surgery
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Measured with Insomnia Severity Index (ISI) questionnaire, points range 0-28, higher is worse.
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Baseline and 6, 12, 24 and 60 months after surgery
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Surgical success rate
Tidsramme: Baseline and 6, 12, 24 and 60 months after surgery
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Defined according to Sher's criteria: a reduction in AHI of >50% and a total AHI of <20 after surgery
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Baseline and 6, 12, 24 and 60 months after surgery
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Surgical cure rate
Tidsramme: Baseline and 6, 12, 24 and 60 months after surgery
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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
Tidsramme: Before surgery and 4-6, 24 and 60 months after surgery
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Changes in nocturnal desaturation measured with oxygen saturation (SaO2) mean, min, and SpO2 <90% (T90) and ODI3, measured with home sleep study
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Before surgery and 4-6, 24 and 60 months after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Jaakko M Piitulainen, MD, PhD, Turku University Hospital
- Hovedetterforsker: Henrik Sjöblom, MD, Turku University Hospital
- Hovedetterforsker: Jenny Knubb, MD, Turku University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VARHA/28047/13.02.02/2025
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
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