NCT04366193

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 12, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 24, 2020

Last Update Submit

April 24, 2020

Conditions

Sleep Apnea

Keywords

sleep apneahome sleep testoximetry

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of high-resolution oximetry for OSA

    Accuracy will be tested against home sleep test using ROC, sensitivity and specificity

    single night

Interventions

OximetryDIAGNOSTIC_TEST

Validation of a high-resolution wireless oximeter for OSA diagnosis comparing with a well established and validated method (home sleep test).

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ambulatory patients who are in a waiting list for polysomnography

You may qualify if:

  • 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

You may not qualify if:

  • patients under treatment for OSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo

São Paulo, 55, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Oximetry

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Blood Gas AnalysisBlood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

December 12, 2019

Primary Completion

April 16, 2020

Study Completion

May 30, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

BR(1)