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A Combined Surgical and Medical Approach in Mild Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University Hospital, Antwerp.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00497120
First received: July 4, 2007
Last updated: July 5, 2007
Last verified: July 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Snoring
U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Polysomnographic parameters

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00497120     History of Changes
Other Study ID Numbers: EC 2/27/99
Study First Received: July 4, 2007
Last Updated: July 5, 2007
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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 Disorders
Nervous System Diseases
Acetazolamide
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013