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Sleep Apnea/Hypopnea SyndromeNCT02143297

Automatic Estimation of the Apnea-hypopnea Index Using Neural Networks to Detect Sleep Apnea

An observational study of Sleep Apnea/Hypopnea Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The sleep apnea hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent breathing cessations (apneas) or partial collapses (hypopneas) during sleep. These respiratory events lead to deep oxygen desaturations, blood pressure and heart rate acute changes, increased sympathetic activity and cortical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Apnea/Hypopnea Syndrome
How many people
322 participants
Where
1 siteSpain
Study dates
Jul 2013to Jul 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects derived to the reference sleep unit from primary care with suspicion of suffering from SAHS due to daytime hypersomnolence, loud snoring, nocturnal choking and awakenings, and/or apnoeic events

Who may be able to join

  • Men and women over 18 years old
  • Subjects submitted to the sleep unit due to previous symptoms of sleep apnea (daytime hypersomnolence, loud snoring, nocturnal choking and awakenings, and/or apnoeic events)
  • Written informed consent signed

Who cannot join

  • Subjects under 18 years old
  • Subjects not signing the informed consent
  • Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
  • Patients with chronic diseases: congestive heart failure, renal failure, neuromuscular diseases, chronic respiratory failure
  • Patients with > 50% of central apneas or the presence of Cheyne-Stokes respiration
  • Previous CPAP treatment for SAHS diagnosis
  • A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario Río Hortega

    Valladolid, Valladolid, 47012

Other trials in Spain

About this study

Official title: Automatic Estimation of Apnea-hypopnea Index (AHI) Using Neural Networks to Assist in the Diagnosis of Sleep Apnea-hypopnea Syndrome (SAHS)

The sleep apnea hypopnea syndrome (SAHS) is a respiratory disorder characterized by frequent breathing cessations (apneas) or partial collapses (hypopneas) during sleep. These respiratory events lead to deep oxygen desaturations, blood pressure and heart rate acute changes, increased sympathetic activity and cortical arousals. The gold standard method for SAHS diagnosis is in-hospital, technician-attended overnight polysomnography (PSG). However, this methodology is labor-intensive, expensive and time-consuming, which has led to large waiting lists, delaying diagnosis and treatment. Blood oxygen saturation (SpO2) from nocturnal pulse oximetry (NPO) provides relevant information to detect apneas, it can be easily recorded ambulatory and it is less expensive and highly reliable. The investigators hypothesize that an automatic analysis of single oximetric recordings at home could provide essential information on the diagnosis of SAHS. The aim of this study is two-fold: firstly, the research focuses on assessing the reliability and usefulness of NPO carried out at patient's home in the context of SAHS detection and, secondly, the study aims at assessing the performance of an automatic regression model of the AHI by means of neural networks using information from NPO recordings. To achieve this goal, both PSG and NPO studies are carried out. A polysomnography equipment (E-Series, Compumedics) is used for standard in-hospital PSG studies, whereas a portable pulseoximeter (WristOX2 3150, Nonin) is used for ambulatory NPO. NPO is carried out the day immediately before or after the PSG at patient's home. Patients are assigned to carry out the NPO study before or after the in-hospital PSG randomly. In addition, in-hospital attended oximetry is also performed simultaneously to the PSG using the portable pulseoximeter.

Read the detailed description

Subjects under study are recruited from the sleep unit of the "Hospital Universitario Río Hortega" (HURH) from Valladolid (Spain). All subjects are derived to the sleep unit due to suspicion of suffering from SAHS. The whole population set is subsequently divided into training set and test set. The training set is used to compose the regression model, whereas the test set is used to further assess its performance.

The standard apnea-hypopnea index (AHI) from PSG is used to diagnose SAHS. According to the American Academy of Sleep Medicine (AASM) rules, apnea is defined as a drop in the airflow signal greater than or equal to 90% from baseline lasting at least 10s, whereas hypopnea is defined as a drop greater than or equal to 50% during at least 10 s accompanied by a desaturation greater than or equal to 3% and/or an arousal. Subjects with an AHI >= 10 events per hour (e/h) are diagnosed as suffering from SAHS.

A portable pulseoximeter (WristOX2 3150, Nonin) is used for ambulatory NPO. NPO is carried out the day immediately before or after the PSG at patient's home. Patients are assigned to carry out the NPO study before or after in-hospital PSG randomly. In addition, oximetry is also performed simultaneously to the PSG by means of the portable pulseoximeter. Therefore, every patient has 3 oximetric recordings: (i) SpO2 from unattended portable monitoring at home, (ii) SpO2 from attended in-hospital portable monitoring and (iii) SpO2 from attended in-hospital standard PSG.

SpO2 is recorded at a sampling rate of 1 Hz. All SpO2 recordings are saved to separate files and process offline. An automatic signal pre-processing stage is carried out to remove artifacts.

Our methodology is divided into two stages: feature extraction and pattern recognition. Oximetric recordings are parameterized by means of 16 features from four feature subsets to compose the initial feature set from oximetry: time domain statistics, frequency domain statistics, conventional spectral measures and nonlinear features. All features are computed for each whole overnight recording.

  • Features 1 to 4. First to fourth-order moments (M1t - M4t) in the time domain: arithmetic mean (M1t), variance (M2t), skewness (M3t) and kurtosis (M4t) are applied to quantify central tendency, amount of dispersion, asymmetry and peakedness, respectively.
  • Features 5 to 8. First to fourth-order moments (M1f - M4f) in the frequency domain.
  • Feature 9. Median frequency (MF), which is defined as the component which comprises 50% of signal power.
  • Feature 10. Spectral entropy (SE), which is a disorder quantifier related to the flatness of the spectrum.
  • Feature 11. Total spectral power (PT), which is computed as the total area under the PSD.
  • Feature 12. Peak amplitude (PA) in the apnea frequency band, which is the local maximum of the spectral content in the frequency range 0.014 - 0.033 Hz.
  • Feature 13. Relative power (PR), which is the ratio of the area enclosed under the PSD in the apnea frequency band to the total signal power.
  • Feature 14. Sample entropy (SampEn), which quantifies irregularity in time series, with larger values corresponding to more irregular data.
  • Feature 15. Central tendency measure (CTM), which provides a variability measure from second order difference plots.
  • Feature 16. Lempel - Ziv complexity (LZC), which is a measure of complexity linked with the rate of new subsequences and their repetition along the signal.

The second stage corresponds to regression analysis, which aims to provide an analytical expression for the AHI as a function of the extracted features. A multilayer perceptron (MLP) neural network is used. MLP networks are models for expressing knowledge using a connectionist paradigm inspired in the human brain. They are composed of multiple simple units or neurons known as perceptrons. Perceptrons are arranged in several interconnected layers. Each network connection between two of them is associated with a network adaptive parameter or weight. MLP networks with a single hidden layer composed of nonlinear perceptrons (i.e., with a nonlinear activation function) are implemented since they are capable of universal approximation. The proposed regression task aims to approximate a 1-D continuous variable representing the AHI. Thus, a single output unit with a linear activation function is required.

Keywords
Sleep Apnea/Hypopnea Syndrome, Pulse Oximetry, Nonlinear Dynamics, Fourier Analysis, Neural Networks (Computer)
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02143297
Study groupRoleWhat they receive
SAHS negativeSubjects derived to the sleep unit due to suspicion of suffering from sleep apnea which finally do not have the disease according to standard PSG
SAHS positiveSubjects derived to the sleep unit due to suspicion of suffering from sleep apnea which finally have the disease according to standard PSG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between our estimated AHI from oximetry and real AHI from gold standard PSG

    A measure of correlation between our estimation of the AHI and the real AHI derived from conventional in-hospital PSG will be measured by means of the intra-class correlation coefficient (ICC). This measure shows how similar are both indexes (estimated AHI and real AHI) in order to assess the severity of SAHS using our estimated AHI. In addition, Bland and Altman plots of agreement between NPO-based estimated AHI and PSG-based standard AHI will be drawn in order to assess under/over-estimation along the whole range of AHI values.

    Measured: 12 months after the inclusion of the last patient

  2. Percentage of patients correctly classified

    Percentage of patients correctly classified by the optimum portable NPO-based algorithm using the NPO-based estimated AHI. PSG is used as the reference gold standard method. Subjects with an AHI >= 10 event per hour (e/h) are considered as suffering from SAHS.

    Measured: 12 months after the inclusion of the last patient

Secondary outcomes (10)
  1. Prevalence of SAHS

    Prevalence of SAHS in patients derived to the sleep unit

    Measured: 12 months (inclusion period)

  2. Severity of SAHS

    Severity of SAHS patients in terms of the AHI

    Measured: 12 months (inclusion period)

  3. Demographic and anthropometric characteristics

    Demographic and anthropometric characteristics of the study population (mean +/- standard deviation): age, gender, body mass index, neck circumference, waist circumference, blood pressure.

    Measured: 12 months (inclusion period)

  4. Clinical characteristics of the study population

    Clinical characteristics of the study population: previous symptoms of suffering from SAHS and additional conditions (hypertension and chronic obstructive pulmonary disease) co-occurring with SAHS according to standard definitions.

    Measured: 12 months (inclusion period)

  5. Patients' lifestyle

    Patients' lifestyle derived from questionnaires on sleep (Epworth Sleepiness Scale, ESS), smoking and alcoholism (Test EuroQol, EQ-5D)

    Measured: 12 months (inclusion period)

  6. PSG-derived variables

    PSG-derived variables (AHI; apnea index (AI); hypopnea index (HI); percentage of time in phase I, II, III, IV and REM sleep; percentage of time in supine position; arousal index; sleep efficiency)

    Measured: 12 months (inclusion period)

  7. Portable NPO-derived variables

    Portable NPO-derived variables (oxygen desaturation index of 3% (ODI3) and 4% (ODI4), cumulative time with a saturation value below 90% (CT90), minimum saturation, average saturation)

    Measured: 12 months (inclusion period)

  8. Compliance with portable device

    Compliance with the portable NPO recording device

    Measured: 12 months (inclusion period)

  9. Physiological interpretation

    Physiological interpretation of features included in the regression model

    Measured: 24 months

  10. Cost-effectiveness

    Cost-effectiveness study of the proposed model for SAHS screening based on AHI estimation from NPO

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2014 (estimated)
  2. Study startJul 2013
  3. Primary completionMar 2014
  4. Study completionJul 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02143297
Sponsor's protocol ID
SEPAR-265/2012
Status last verified
May 2014
First submitted
15 May 2014
Last updated
21 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea/Hypopnea Syndrome, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between our estimated AHI from oximetry and real AHI from gold standard PSG (time frame: 12 months after the inclusion of the last patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.

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