Sleep Apnea and Periodic Breathing (DLI)

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. Identifier: NCT00936273
Recruitment Status : Unknown
Verified July 2009 by Medical Center Alkmaar.
Recruitment status was:  Recruiting
First Posted : July 10, 2009
Last Update Posted : July 10, 2009
Information provided by:
Medical Center Alkmaar

Brief 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).

Condition or disease
Sleep Apnea Syndrome

Detailed 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 Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Screening for Sleep Apnea Using Home Recording of the Double Loop Gain as a Measure of Periodic Breathing
Study Start Date : June 2009

Resource links provided by the National Library of Medicine

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

Suspected sleep apnea syndrome
Outpatients with suspected sleep apnea syndrome, age > 18 year

Primary Outcome Measures :
  1. To determine DLI threshold with optimal sensitivity and specificity. The DLI threshold is the DLI value above which the test is considered positive. The optimal DLI threshold will be taken as the value that gives the highest area under the ROC curve. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To test the hypothesis that the sensitivity and specificity of the screening are higher when the DLI is used instead of the AHI [ Time Frame: 1 year ]
  2. To assess the repeatability of the DLI using home and in-hospital recordings of nasal pressure and saturation (SaO2). [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients suspected for sleep apnea syndrome

Inclusion Criteria:

  • Suspected sleep apnea syndrome
  • > 18 yr
  • Outpatient
  • Able and willing to use the necessary equipment for registration of nasal pressure and O2 saturation at home

Exclusion Criteria:

  • hospitalized patients
  • < 18 yr
  • Not able to use the necessary equipment

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 identifier (NCT number): NCT00936273

Contact: J.G. van den Aardweg, Dr. +3172-5482750

Medical Center Alkmaar Recruiting
Alkmaar, Wilhelminalaan 12, Netherlands, 1815 JD
Contact: J.G. van den Aardweg, dr.    +3172-5482750   
Sponsors and Collaborators
Medical Center Alkmaar
Study Director: J.G. van den Aardweg, dr Medical Center Alkmaar

Responsible Party: Dr. J.G. van den Aardweg, MD, Medical Center Alkmaar Identifier: NCT00936273     History of Changes
Other Study ID Numbers: Double loop gain MCA 2009
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: July 2009

Keywords provided by Medical Center Alkmaar:
Sleep apnea syndrome
double loop gain
double loop index
periodic breathing

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes