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Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis

NCT05057975 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 848

Last updated 2024-12-06

No results posted yet for this study

Summary

Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm, open-label, multicenter, national, controlled study.

Conditions

Interventions

DEVICE

Sunrise

Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.

DEVICE

polysomnography

Reference protocol to diagnose OSA (in-lab or outpatient PSG)

Sponsors & Collaborators

  • ICUREsearch

    collaborator INDUSTRY

  • Sunrise

    lead INDUSTRY

Principal Investigators

  • Jean-Louis PEPIN, Pr · CHU Grenoble Alpes

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2024-10-07
Completion
2024-10-07

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057975 on ClinicalTrials.gov