Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea (Ignite)

May 17, 2026 updated by: ResMed

Innovation and Growth Network for Insightful Trends and Evaluation - Data Collection Study

This study will collect data on a range of signals such as facial scans, videos (including speaking, blinking and swallowing) and heart rate variability to assess whether any of these measures are useful for diagnosing obstructive sleep apnea

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2153
        • Recruiting
        • Resmed Sleep Clinic, Bella Vista
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults who are being tested for obstructive sleep apnea

Description

Inclusion Criteria:

Adults aged >= 18 Ability to read and comprehend English

Exclusion Criteria:

  • Previous diagnosis of OSA
  • Respiratory diseases (such COPD, lung cancer, fibrosis of the lungs, lung injury)
  • Subjects who are or may be pregnant, breastfeeding or within 6 weeks postpartum (which may impact HRV temporarily)
  • Subjects with a pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People being investigated for obstructive sleep apnea
People who are undergoing testing (home sleep testing or polysomnography) due to suspicion of sleep apnea will be invited to take part
Other: facial scans, videos and heart rate variability measurements
Ignite app to collect data (videos, photos and heart rate variability)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of measurement and obstructive sleep apnea status
Time Frame: 1 day
- Area under the ROC curve (AUC) for each modality and their combinations in predicting moderate/severe OSA (AHI ≥15).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA08042025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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