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Sleep ApneaNCT03526133

Validation of Sleep Apnea Diagnosis Device

An observational study of Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for OSA diagnosis are necessary. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Sleep Apnea
What is being tested?
Polysomnography (PSG) and wireless sensor Oxistar
How many people
300 participants
Where
1 siteBrazil
Study dates
7 Jul 2017to 7 Feb 2019
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Consecutive patients referred to a university-based tertiary sleep referral centre.

Who may be able to join

  • referred by medical staff for an overnight assessment for suspected sleep apnea

Who cannot join

  • polysomnography for the CPAP titration

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Incor - Heart Institute, Sleep Laboratory

    São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: Validation of a Wireless Wearable Sensor Using Mobile Technology and Cloud Computing for the Diagnosis of Sleep Apnea

Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for OSA diagnosis are necessary. The overnight oximetry with the oxygen desaturation index (ODI) has been largely investigated as a diagnostic test for OSA but its accuracy remains undefined. The aim of our study is to evaluate if an wireless polygraph (Oxistar) is accurate to diagnosis OSA in patients referred to a Sleep Lab.

Read the detailed description

Consecutive patients referred to the sleep laboratory with suspected diagnosis of OSA underwent in-laboratory polysomnography (PSG) and simultaneously wireless polygraph. The PSG oximeter and the wireless polygraph were worn on different fingers of the same hand. All sleep studies were reviewed by one blind investigator according the 2017 American Academy of Sleep Medicine recommendations. The number of desaturations from wireless polygraph at the 3 predefined threshold levels (of ODI-2%, ODI-3%, or ODI-4%) was derived automatically using proprietary algorithm. Moderate to severe OSA was defined as AHI ≥ 15 events/h. The diagnostic accuracy of ODI-2%, 3%, and 4% for the diagnosis of moderate-severe OSA were calculated for cut-off values from 1 to 20 desaturation events/h. The sleep actimetry was compared with the sleep stages from PSG, most of the statistical metrics applied for diagnosis were used to evaluate the applicability of this proposed method. Finally, the snoring events computed by the smartphone application were compared with the events heard by a specialist and the statistical comparison metrics were evaluated.

Conditions
Sleep Apnea
Being tested
Polysomnography (PSG) and wireless sensor Oxistar
Keywords
sleep apnea, polygraph, home sleep apnea test (HSAT), apnea hypopnea index (AHI), oxygen desaturation index (ODI), portable monitor, sleep actimetry, snoring
Medical subject headings
Sleep Apnea Syndromes, Snoring

What participants receive

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

  • Polysomnography (PSG) and wireless sensor OxistarDiagnostic test

    Monitoring the apnea-hypopnea index (AHI) derived from PSG and the oxygen desaturation index (ODI) obtained by the Oxistar.

What is being measured

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

  1. Sensitivity

    Sensitivity of Oxistar device to detect apnea events compared to gold-standard polysomnography

    Measured: Night during the polysomnography exam

  2. Specificity

    Specificity of Oxistar device to detect apnea events compared to gold-standard polysomnography

    Measured: Night during the polysomnography exam

  3. Area under the curve (AUC)

    AUC from ROC curves reflects the accuracy of Oxistar device to detect apnea events compared to gold-standard polysomnography

    Measured: Night during the polysomnography exam

  4. Bland-Altman Graph

    The Bland-Altman graph evaluates the "agreement" between the gold-standard polysomnography and Oxistar device

    Measured: Night during the polysomnography exam

  5. Interclass Correlation Coefficient (ICC)

    ICC measures the reliability of measurements or ratings between the gold-standard polysomnography and Oxistar device

    Measured: Night during the polysomnography exam

Secondary outcomes (2)

  1. Sleep Actigraphy

    Actigraphy is the continuous measurement of activity or movement with the use of a small device called an actigraph. Periods of movement suggest wakefulness while those of relative stillness would likely correspond to sleep or quiescence. The Oxistar has a embeded actigraph whose data will be compared with the sleep stage scoring from polysomnography (PSG), the gold standard for sleep assessment. Epoch-by-epoch (30 seconds) agreement between the actigraph and PSG will be assessed by calculating sensitivity, specificity, accuracy, area under the curve (AUC), Bland-Altman graph and interclass correlation coefficient (ICC)

    Measured: Night during the polysomnography exam

  2. Number of snoring events per hour of register (snoring/h)

    Snoring is one of the signs suggestive of obstructive sleep apnea and has recently been considered as having great diagnostic potential. The smartphone application (app) through microphone performs the recording and the characteristics extraction of the patient's audio during sleep (register time). A multilayer perceptron (MPL) neural network classifies the event as snoring or non-snoring. Lastly, the amount of snoring occured is accounted and divided by the register time leading to the number of snoring/h. The agreement between snoring/h measured by the app and the heard by a specialist will be assessed by calculating sensitivity, specificity, accuracy and area under the curve (AUC).

    Measured: Night during the polysomnography exam

Timeline

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

  1. First posted16 May 2018
  2. Study start7 Jul 2017
  3. Primary completion7 Dec 2018
  4. Study completion7 Feb 2019

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
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03526133
Sponsor's protocol ID
70485317.0.0000.0068
Status last verified
Jul 2018
First submitted
12 Apr 2018
Last updated
30 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pinheiro GDL, Cruz AF, Domingues DM, Genta PR, Drager LF, Strollo PJ, Lorenzi-Filho G. Validation of an Overnight Wireless High-Resolution Oximeter plus Cloud-Based Algorithm for the Diagnosis of Obstructive Sleep Apnea. Clinics (Sao Paulo). 2020 Nov 27;75:e2414. doi: 10.6061/clinics/2020/e2414. eCollection 2020.

    PubMed 33263626

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: finished, as of the sponsor's last update on 30 Sep 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sensitivity (time frame: Night during the polysomnography exam). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03526133, which also lists 1 linked publication.

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 30 Sep 2019.

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