A Combined Surgical and Medical Approach in Mild Sleep Apnea

This study is currently recruiting participants.

Verified by University Hospital, Antwerp, July 2007

Sponsored by:	University Hospital, Antwerp
Information provided by:	University Hospital, Antwerp
ClinicalTrials.gov Identifier:	NCT00497120

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

MedlinePlus related topics: Sleep Apnea Snoring

Drug Information available for: Acetazolamide Acetazolamide sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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, Antwerp
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

Study ID Numbers:	EC 2/27/99
Study First Received:	July 4, 2007
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00497120
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

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Acetazolamide

Snoring
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Carbonic Anhydrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Diuretics

Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009