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A Combined Surgical and Medical Approach in Mild Sleep Apnea

A

Antwerp University Hospital (UZA)

Status

Unknown

Conditions

Sleep Apnea

Treatments

Drug: placebo
Drug: acetazolamide
Procedure: uvulopalatopharygoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT00497120
EC 2/27/99

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Wilfried De Backer, MD PhD

Data sourced from clinicaltrials.gov

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