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A Combined Surgical and Medical Approach in Mild Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497120
Recruitment Status : Unknown
Verified July 2007 by University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : July 6, 2007
Last Update Posted : July 6, 2007
Information provided by:
University Hospital, Antwerp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: acetazolamide Drug: placebo Procedure: uvulopalatopharygoplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Primary Outcome Measures :
  1. Polysomnographic parameters

Secondary Outcome Measures :
  1. subjective sleepiness
  2. subjective snoring
  3. satisfaction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497120

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Contact: Wilfried De Backer, MD PhD +32 3 821 34 47

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University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Olivier M Vanderveken, MD   
Sub-Investigator: Olivier M Vanderveken, MD         
Sub-Investigator: Annick Devolder, MD         
Sponsors and Collaborators
University Hospital, Antwerp
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Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
Layout table for additonal information Identifier: NCT00497120    
Other Study ID Numbers: EC 2/27/99
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: July 6, 2007
Last Verified: July 2007
Keywords provided by University Hospital, Antwerp:
sleep apnea
daytime sleepiness
upper airway
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs