RCT Between UPP and Controls in Adult OSA

Karolinska University Hospital

Status: Withdrawn

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: UPP

Study type: Interventional

Funder types: Other

Identifiers

NCT02522247

2015/755-31/2B

Details and patient eligibility

About

To compare the effect of uvulopalatoplasty with no treatment in treating adult OSA.

Full description

Two arms: the intervention group undergo uvulopalatoplasty one month after baseline polysomnography (PSG1) and a PSG2 6 months after surgery .

The control group perform PSG 1 and are then waiting 6 months, thereafter undergo PSG2, then surgery and PSG3 6 months after surgery. All patients are followed for four years with PSG. Patients fill in questionnaires at PSG sessions, and blood pressure control the morning after.

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AHI of 15 or more
• Friedmans stage I+II
• Tonsil size 0-1
• BMI<34
• ESS värde >7
• Failed treatment with CPAP and mandibular device

Exclusion criteria

• Severe cardiovascular or neurological disease
• ASA IV
• Not interested in surgical treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Uvulopalatoplasty

Active Comparator group

Description:

Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle

Treatment:

Procedure: UPP

Controls

No Intervention group

Description:

Only waiting 6 months