A Combined Surgical and Medical Approach in Mild Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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acetazolamide

Intervention Type DRUG

placebo

Intervention Type DRUG

uvulopalatopharygoplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Wilfried De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

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University Hospital Antwerp

Edegem, Antwerp, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Wilfried De Backer, MD PhD

Role: CONTACT

[email protected]

+32 3 821 34 47

Facility Contacts

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Olivier M Vanderveken, MD

Role: primary