RCT Between UPP and Controls in Adult OSA

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: UPP

• Registration Number: NCT02522247
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2015-12-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uvulopalatoplasty	UPP	Surgery with cold steel, single sutures of palate and tonsillar pillars including palatopharyngeal muscle

Primary Outcome Measures

Name	Time	Method
Polysomnography: group differences in changes of apnea-hypopnea index (AHI)	6 months	compare the two groups of changes in number of apneas and hypopneas per sleep hour measured with inlab polysomnography, between baseline and follow-up

Secondary Outcome Measures

Name	Time	Method
Questionnaire: group differences in changes of daytime sleepiness	6 months	using validated questionnaire Epworth sleepiness scale measure changes between baseline and follow-up and compare the differences between groups
Questionnaire: group differences in changes of general health	6 months	using validated question
Blood pressure: group differences in changes of blood pressure	6 months

Trial Locations

Locations (1)

Orl dep, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden