Clinical trial NCT00936273: Sleep Apnea and Periodic Breathing
Official title: Screening for Sleep Apnea Using Home Recording of the Double Loop Gain as a Measure of Periodic Breathing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndrome
Keywords: Sleep apnea syndrome
SAS
double loop gain
DLI
double loop index
periodic breathing
polysomnography
Lead sponsor: Medical Center Alkmaar
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients suspected for sleep apnea syndrome

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).

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 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: To test the hypothesis that the sensitivity and specificity of the screening are higher when the DLI is used instead of the AHI
timeFrame: 1 year
measure: To assess the repeatability of the DLI using home and in-hospital recordings of nasal pressure and saturation (SaO2).
timeFrame: 1 year
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
state: Wilhelminalaan 12
Study officials:
affiliation: Medical Center Alkmaar
name: J.G. van den Aardweg, dr
role: STUDY_DIRECTOR
References: