Clinical Trials Logo
  1. Home
  2. Sleep Apnea
  3. NCT00497120
  4. Details
NCT00497120 Clinical Trial

A Combined Surgical and Medical Approach in Mild Sleep Apnea

Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00497120
Other study ID # EC 2/27/99
Secondary ID
Status Recruiting
Phase N/A
First received July 4, 2007
Last updated July 5, 2007

Study information
Verified date July 2007
Source University Hospital, Antwerp
Contact Wilfried De Backer, MD PhD
Phone +32 3 821 34 47
Email wilfried.debacker@ua.ac.be
Is FDA regulated No
Health authority Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• acetazolamide

• placebo

Procedure:
• uvulopalatopharygoplasty

Locations
Country Name City State
Belgium University Hospital Antwerp Edegem Antwerp

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Polysomnographic parameters
Secondary subjective sleepiness
Secondary subjective snoring
Secondary satisfaction
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT03919955 - A Novel Pharmacological Therapy for Obstructive Sleep Apnea Phase 2
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00747890 - Surgical Treatment of Mild Obstructive Sleep Apnea N/A
Active, not recruiting NCT00738179 - Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease Phase 3
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Completed NCT00202501 - Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome N/A
Completed NCT00047463 - Effects of Treating Obstructive Sleep Apnea in Epilepsy Phase 2
Not yet recruiting NCT06029881 - Portable System for Non-intrusive Monitoring of Sleep
Recruiting NCT06093347 - Central Apnoea Monitor Study
Terminated NCT05445869 - Severe OSA Study (SOS) N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT04575740 - Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea N/A
Completed NCT04676191 - Validation of a Contactless Vital Signs Measurement Sensor N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT06051097 - Metabolic Syndrome and Obstructive Sleep Apnea
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury