NCT03526133

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
Last Updated

September 30, 2019

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

April 12, 2018

Last Update Submit

September 27, 2019

Conditions

Sleep Apnea

Keywords

sleep apneapolygraphhome sleep apnea test (HSAT)apnea hypopnea index (AHI)oxygen desaturation index (ODI)portable monitorsleep actimetrysnoring

Outcome Measures

Primary Outcomes (5)

  • Sensitivity

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

    Night during the polysomnography exam

  • Specificity

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

    Night during the polysomnography exam

  • Area under the curve (AUC)

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

    Night during the polysomnography exam

  • Bland-Altman Graph

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

    Night during the polysomnography exam

  • Interclass Correlation Coefficient (ICC)

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

    Night during the polysomnography exam

Secondary Outcomes (2)

  • Sleep Actigraphy

    Night during the polysomnography exam

  • Number of snoring events per hour of register (snoring/h)

    Night during the polysomnography exam

Interventions

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • polysomnography for the CPAP titration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incor - Heart Institute, Sleep Laboratory

São Paulo, 05403-900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 33263626DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSnoring

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Geraldo Lorenzi-Filho, MD, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

May 16, 2018

Study Start

July 7, 2017

Primary Completion

December 7, 2018

Study Completion

February 7, 2019

Last Updated

September 30, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)