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A Combined Surgical and Medical Approach in Mild Sleep Apnea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by University Hospital, Antwerp.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497120
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
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.
Information provided by:
University Hospital, Antwerp
  Purpose
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 Intervention
Sleep Apnea Drug: acetazolamide Drug: placebo Procedure: uvulopalatopharygoplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Polysomnographic parameters

Secondary Outcome Measures:
  • subjective sleepiness
  • subjective snoring
  • satisfaction

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00497120


Contacts
Contact: Wilfried De Backer, MD PhD +32 3 821 34 47 wilfried.debacker@ua.ac.be

Locations
Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Olivier M Vanderveken, MD       olivier.vanderveken@uza.be   
Sub-Investigator: Olivier M Vanderveken, MD         
Sub-Investigator: Annick Devolder, MD         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
  More Information

ClinicalTrials.gov Identifier: NCT00497120     History of Changes
Other Study ID Numbers: EC 2/27/99
First Submitted: July 4, 2007
First Posted: July 6, 2007
Last Update Posted: July 6, 2007
Last Verified: July 2007

Keywords provided by University Hospital, Antwerp:
sleep apnea
snoring
acetazolamide
uvulopalatopharyngoplasty
daytime sleepiness
upper airway

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs