Comparison Between UPPP and Tonsillectomy in Adult OSA

Karolinska University Hospital

Status: Terminated

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: Uvulopalatopharyngoplasty; Procedure: tonsillectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02523248

2015/755-31/2

Details and patient eligibility

About

The aim of this randomized control study is to evaluate the effect of tonsillectomy with or without uvulopalatoplasty in treating adults with moderate to severe sleep apnea.

Full description

Patients are after baseline PSG 1 included and randomized to either UPPP or TE. They are stratified according to tonsil size, those with size 2 in one group and those with 3-4 in another. They all undergo surgery within two months and thereafter PSG 2 after 6 months and PSG after 4 years. At PSG they fill in questionnaires and measurements of blood pressure.

Enrollment: 100 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AHI more than 15
• Friedmans stage I and II
• Tonsil size 2, 3 and 4
• BMI below 34
• Failed use of CPAP and dental device

Exclusion criteria

• Severe cardiovascular or neurological disease
• Prefers strongly one surgical method
• ASA IV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Tonsillectomy

Active Comparator group

Description:

Tonsillectomy with cold steel

Treatment:

Procedure: tonsillectomy

Uvulopalatopharyngoplasty

Active Comparator group

Description:

Tonsillectomy and uvulopalatoplasty; using cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle

Treatment:

Procedure: Uvulopalatopharyngoplasty