Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the double loop index (DLI) threshold with optimal sensitivity and specificity. The investigators hypothesize that the DLI gives a better reflection of the pathophysiology of the disease than the apnea-hypopnea-index (AHI).


Clinical Trial Description

Sleep apnea syndrome (SAS) is characterized by repetitive events of apnea and hypopnea. These events are often part of a periodic breathing pattern, in which relative hyperventilation is followed by apnea or hypopnea.

Recently the investigators described the 'double-loop gain' of the respiratory control system as a measure of periodic breathing. This is a frequency-dependent variable which describes 1) the tendency of the respiratory system to oscillate at a given frequency and 2) the degree to which the relation between oscillations in ventilation and oscillations in arterial blood gas values is linear. The underlying hypothesis is that periodic breathing results from negative feedback regulation of arterial O2 and CO2 pressure through the chemoreflexes. The double-loop gain describes the gain in the negative feedback loop under the assumption that accidental changes occur in both ventilation and arterial blood gas pressures. A simple version of the double-loop gain is derived from nasal pressure changes and arterial O2 saturation. From all-night recordings, the 'double-loop index' (DLI) can be derived, which is determined by the time during which the double-loop gain exceeds a given threshold.

Currently, the presence of sleep-apnea is determined by the apnea-hypopnea index (AHI), using in-hospital sleep recording. With a growing number of referrals, waiting lists for sleep registration are emerging. Screening for SAS using home-measurement of nasal pressure and SaO2 seems to be a good alternative. The investigators hypothesize that the DLI derived from these signals gives a better reflection of the pathophysiology of the disease than the AHI. As a result, the investigators expect that the DLI improves the distinction between healthy and diseased subjects in comparison to the simple counting of apneas and hypopneas. This is reflected in a higher area under the ROC curve, which describes the sensitivity and specificity of the test. ;


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT00936273
Study type Observational
Source Medical Center Alkmaar
Contact J.G. van den Aardweg, Dr.
Phone +3172-5482750
Email j.g.vanden.aardweg@mca.nl
Status Recruiting
Phase N/A
Start date June 2009

See also
  Status Clinical Trial Phase
Completed NCT02916160 - Sacubitril-valsartan and Heart Failure Patients : the ENTRESTO-SAS Study Phase 4
Active, not recruiting NCT00746928 - Cardiovascular Consequences of Intermittent Hypoxia in Healthy Subjects N/A
Terminated NCT00816829 - Effect of Fenofibrate on Sleep Apnea Syndrome Phase 2
Recruiting NCT00152711 - Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis N/A
Completed NCT02482480 - Comprehensive Management for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT02408172 - Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome Phase 2/Phase 3
Terminated NCT01354756 - Validation of Apnea LinkTM for Sleep Apnea Syndrome Screening in a Bariatric Population N/A
Terminated NCT01196845 - Inflammation and Oxidative Stress of Adipose Tissue in Sleep Apnea Syndrome N/A
Completed NCT03116958 - MyOSA : Management and Treatment of Patients With Obstructive Sleep Apnea Syndrome(OSAS) Through a Telemedicine System N/A
Terminated NCT02649933 - Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course N/A
Completed NCT02789696 - Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome N/A
Completed NCT01164631 - Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment Phase 4
Completed NCT00317083 - Cough Reflex and Obstructive Sleep Apnea Syndrome N/A
Completed NCT02893865 - Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure N/A
Completed NCT02234765 - Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care N/A
Completed NCT01752556 - Cost-effectiveness of Home Respiratory Polygraphy Phase 3
Completed NCT00001723 - Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases Phase 2
Completed NCT02148432 - Establishment of Ideal IV Sedative Regimen for Successful Fiberoptic Bronchoscopy in Assessing the Site, Severity of Sleep Apnea Syndrome N/A
Completed NCT02657304 - Effect of Early Education on the Observance of CPAP Treatment N/A
Completed NCT02591979 - PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment