Sleep ApneaNCT04366193
High-resolution Oximetry to Diagnose Obstructive Sleep Apnea
An observational study of Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Oximetry
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2019to 30 May 2020
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult ambulatory patients who are in a waiting list for polysomnography
Who may be able to join
- Adult ambulatory patients who are in a waiting list for polysomnography that are able to properly place the oximeter and home sleep test at home
Who cannot join
- patients under treatment for OSA
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, 55
Pedro R Genta, MD, 551126625486, prgenta@gmail.com
About this study
Official title: Validation of a High-resolution Oximeter Using a Cloud-based Algorithm to Diagnose Obstructive Sleep Apnea
The aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG).
Read the detailed description
Obstructive Sleep Apnea (OSA) is extremely common has prompted the popularization of home sleep test (HST). HST record a limited number of respiratory signals, provide a more comfortable testing option to the patient at a lower cost. HST has a performance as good as PSG among patients with suspected OSA and no significant co-morbidities.
Our study was designed to investigate the performance of a simple solution that consists of a high-resolution wireless oximeter with a built-in accelerometer linked to a smartphone application and automated cloud algorithm for detection of oxygen desaturation, described herein as Overnight Digital Monitoring (ODM) (BilogixTM). We will compare the results of ODM with HST performed by ApneaLink Air by Resmed®.
We have already compared ODM to PSG with excellent results in a prior study and intend to see the results in uncontrolled environment (home) .
Population: Men and women from the São Paulo Department of Health, who are awaiting examination for diagnosis of OSAS.We intend to compare the ODM with the HST. Patients with indication for CPAP titration will be excluded. The participants will wear a wireless oximeter (Oxistar, Biologix Sistemas Ltda., Brazil) with a built-in accelerometer on a finger of the same hand as the HST oximeter and we will compare both methods for diagnosing OSA.
All HST studies will be scored by 2 independent certified technicians blinded to the ODM results. Hypopnea will be defined as a peak signal excursion drop by ≥ 30% of pre-event baseline nasal pressure signal lasting ≥ 10 sec. Hypopneas will be scored according the acceptable AASM criteria for hypopnea (≥ 4% reduction in SpO2). Mild, moderate and severe OSA will be defined according to the current standards (5 ≤ AHI <15; 15 ≤ AHI <30 and AHI ≥30 events/h, respectively).ODI results from ODM will be expressed as the number of desaturations per recording time and will be automatically analyzed at the cloud. In order to compare with TST-AHI4%, ODM will be matched using 4% desaturation criteria (ODM-ODI4%, respectively).
- Conditions
- Sleep Apnea
- Being tested
- Oximetry
- Keywords
- sleep apnea, home sleep test, oximetry
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OximetryDiagnostic test
Validation of a high-resolution wireless oximeter for OSA diagnosis comparing with a well established and validated method (home sleep test).
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of high-resolution oximetry for OSA
Accuracy will be tested against home sleep test using ROC, sensitivity and specificity
Measured: single night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start12 Dec 2019
- Primary completion16 Apr 2020
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraldo Lorenzi Filho, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366193
- Sponsor's protocol ID
- 3767871
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a High-resolution Oximeter Using a Cloud-based Algorithm to Diagnose Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04366193
- Acronym / sponsor ID
- 3767871
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, home sleep test, oximetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 28 Apr 2020 (actual)
- 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 aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG).
Detailed description
Obstructive Sleep Apnea (OSA) is extremely common has prompted the popularization of home sleep test (HST). HST record a limited number of respiratory signals, provide a more comfortable testing option to the patient at a lower cost. HST has a performance as good as PSG among patients with suspected OSA and no significant co-morbidities.
Our study was designed to investigate the performance of a simple solution that consists of a high-resolution wireless oximeter with a built-in accelerometer linked to a smartphone application and automated cloud algorithm for detection of oxygen desaturation, described herein as Overnight Digital Monitoring (ODM) (BilogixTM). We will compare the results of ODM with HST performed by ApneaLink Air by Resmed®.
We have already compared ODM to PSG with excellent results in a prior study and intend to see the results in uncontrolled environment (home) .
Population: Men and women from the São Paulo Department of Health, who are awaiting examination for diagnosis of OSAS.We intend to compare the ODM with the HST. Patients with indication for CPAP titration will be excluded. The participants will wear a wireless oximeter (Oxistar, Biologix Sistemas Ltda., Brazil) with a built-in accelerometer on a finger of the same hand as the HST oximeter and we will compare both methods for diagnosing OSA.
All HST studies will be scored by 2 independent certified technicians blinded to the ODM results. Hypopnea will be defined as a peak signal excursion drop by ≥ 30% of pre-event baseline nasal pressure signal lasting ≥ 10 sec. Hypopneas will be scored according the acceptable AASM criteria for hypopnea (≥ 4% reduction in SpO2). Mild, moderate and severe OSA will be defined according to the current standards (5 ≤ AHI <15; 15 ≤ AHI <30 and AHI ≥30 events/h, respectively).ODI results from ODM will be expressed as the number of desaturations per recording time and will be automatically analyzed at the cloud. In order to compare with TST-AHI4%, ODM will be matched using 4% desaturation criteria (ODM-ODI4%, respectively).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ambulatory patients who are in a waiting list for polysomnography
Key inclusion criteria (1 listed)
- Adult ambulatory patients who are in a waiting list for polysomnography that are able to properly place the oximeter and home sleep test at home
Key exclusion criteria (1 listed)
- patients under treatment for OSA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OximetryValidation of a high-resolution wireless oximeter for OSA diagnosis comparing with a well established and validated method (home sleep test). | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of high-resolution oximetry for OSA
Time frame: single night
Accuracy will be tested against home sleep test using ROC, sensitivity and specificity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Related trials for Sleep Apnea
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
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.
Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil
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, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 inclusion and 1 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 28 Apr 2020. 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 Brazil. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of high-resolution oximetry for OSA (time frame: single night). 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 28 Apr 2020.