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.
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.
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.
- Conditions
- Sleep Apnea/Hypopnea Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| SAHS negative | Subjects 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 positive | Subjects 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.
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
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)
Prevalence of SAHS
Prevalence of SAHS in patients derived to the sleep unit
Measured: 12 months (inclusion period)
Severity of SAHS
Severity of SAHS patients in terms of the AHI
Measured: 12 months (inclusion period)
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)
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)
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)
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)
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)
Compliance with portable device
Compliance with the portable NPO recording device
Measured: 12 months (inclusion period)
Physiological interpretation
Physiological interpretation of features included in the regression model
Measured: 24 months
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.
- First posted21 May 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea/Hypopnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Félix del Campo, University of Valladolid
- Investigators
- Felix Del Campo, PhD, MD, Principal investigator, Hospital Universitario Río Hortega, University of Valladolid
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
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Estimation of Apnea-hypopnea Index (AHI) Using Neural Networks to Assist in the Diagnosis of Sleep Apnea-hypopnea Syndrome (SAHS)
- ClinicalTrials.gov ID
- NCT02143297
- Acronym / sponsor ID
- SEPAR-265/2012
- Conditions
- Sleep Apnea/Hypopnea Syndrome
- Keywords
- Sleep Apnea/Hypopnea Syndrome, Pulse Oximetry, Nonlinear Dynamics, Fourier Analysis, Neural Networks (Computer)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAHS negative | – | –Subjects 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 positive | – | –Subjects derived to the sleep unit due to suspicion of suffering from sleep apnea which finally have the disease according to standard PSG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Percentage of patients correctly classified
Time frame: 12 months after the inclusion of the last patient
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.
10 secondary outcomes
Prevalence of SAHS
Time frame: 12 months (inclusion period)
Severity of SAHS
Time frame: 12 months (inclusion period)
Demographic and anthropometric characteristics
Time frame: 12 months (inclusion period)
Clinical characteristics of the study population
Time frame: 12 months (inclusion period)
Patients' lifestyle
Time frame: 12 months (inclusion period)
PSG-derived variables
Time frame: 12 months (inclusion period)
Portable NPO-derived variables
Time frame: 12 months (inclusion period)
Compliance with portable device
Time frame: 12 months (inclusion period)
Physiological interpretation
Time frame: 24 months
Cost-effectiveness
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Biomedical Engineering Group (GIB) WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Del Campo, PhD, MD principal investigator
Hospital Universitario Río Hortega, University of Valladolid
1 site in 1 country: see every site and its status.
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.