Sleep Apnea, Obstructives, Tonsil Hypertrophy
Conditions
Keywords
sleep apnea, tonsillectomy, tonsillotomy, intracapsular tonsillectomy, adults, tonsil hypertrophy
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.
Detailed description
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.
Interventions
PROCEDURETonsillectomy
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.
PROCEDURETonsillotomy
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
Turku University Hospital
Tampere University Hospital
Oulu University Hospital
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in AHI at baseline and after surgery | baseline, 4-6, 24 and 60 months after surgery. | The primary outcome is changes in AHI measured with home sleep study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime sleepiness | 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. |
| Changes in insomnia symptoms | Baseline and 6, 12, 24 and 60 months after surgery | Measured with Insomnia Severity Index (ISI) questionnaire, points range 0-28, higher is worse. |
| Surgical success rate | 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 |
| Surgical cure rate | Baseline and 6, 12, 24 and 60 months after surgery | Defined as a total AHI of \<5 after surgery |
| Changes in nocturnal desaturation | 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 |
Countries
Finland
Contacts
CONTACTJaakko M Piitulainen, MD, PhD
CONTACTHenrik Sjöblom, MD
STUDY_DIRECTORJaakko M Piitulainen, MD, PhD
Turku University Hospital
PRINCIPAL_INVESTIGATORHenrik Sjöblom, MD
Turku University Hospital
PRINCIPAL_INVESTIGATORJenny Knubb, MD
Turku University Hospital
Outcome results
None listed