Sleep Apnea and Periodic Breathing (DLI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Medical Center Alkmaar.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00936273
First received: July 9, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Sleep Apnea Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the repeatability of the DLI using home and in-hospital recordings of nasal pressure and saturation (SaO2). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Groups/Cohorts
Suspected sleep apnea syndrome
Outpatients with suspected sleep apnea syndrome, age > 18 year

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients suspected for sleep apnea syndrome

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936273

Contacts
Contact: J.G. van den Aardweg, Dr. +3172-5482750 j.g.vanden.aardweg@mca.nl

Locations
Netherlands
Medical Center Alkmaar Recruiting
Alkmaar, Wilhelminalaan 12, Netherlands, 1815 JD
Contact: J.G. van den Aardweg, dr.    +3172-5482750    j.g.vanden.aardweg@mca.nl   
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Study Director: J.G. van den Aardweg, dr Medical Center Alkmaar
  More Information

No publications provided

Responsible Party: Dr. J.G. van den Aardweg, MD, Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT00936273     History of Changes
Other Study ID Numbers: Double loop gain MCA 2009
Study First Received: July 9, 2009
Last Updated: July 9, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on August 28, 2014