A Combined Surgical and Medical Approach in Mild Sleep Apnea

University Hospital, Antwerp

Overview

The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Sleep Apnea

Interventions

acetazolamideDRUG

placeboDRUG

uvulopalatopharygoplastyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 5 ≤ Apnea Hypopnea Index (AHI) \< 20 * Socially disturbing snoring: Visual Analogue Scale (VAS)snoring \> 6/10 * Based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (UPPP) Exclusion Criteria: * Previous surgical treatment for sleep-disordered breathing. * Periodic Limb Movement Disorder (PLMD) with arousals and other reasons possibly explaining the Excessive Daytime Sleepiness (EDS) based on Epworth Sleepiness Scale (ESS). * Forced expiratory volume in 1 second (FEV1) \< 80 % pred. * Echocardiography: ejectionfraction \< 35 % or dyastolic dysfunction grade 2 or more.

Locations (1)

University Hospital Antwerp

Edegem, Antwerp, Belgium

RECRUITING

Outcomes

Primary Outcomes

Polysomnographic parameters

Secondary Outcomes

subjective sleepiness

subjective snoring

satisfaction

Central Contacts

Wilfried De Backer, MD PhD

CONTACT

+32 3 821 34 47 wilfried.debacker@ua.ac.be

Data from ClinicalTrials.gov

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