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

NCT06930404 | Recruiting

• 1 other identifier: MA08042025
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

diagnosis; screening

Outcome Measures

Primary Outcomes (1)

• Correlation of measurement and obstructive sleep apnea status

  \- Area under the ROC curve (AUC) for each modality and their combinations in predicting moderate/severe OSA (AHI ≥15).

  1 day

Study Arms (1)

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

Interventions

facial scans, videos and heart rate variability measurements OTHER

Ignite app to collect data (videos, photos and heart rate variability)

People being investigated for obstructive sleep apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who are being tested for obstructive sleep apnea

You may qualify if:

• Adults aged \>= 18 Ability to read and comprehend English

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Resmed Sleep Clinic, Bella Vista

Sydney, New South Wales, 2153, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disease

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Central Study Contacts

Alison Wimms, PhD

CONTACT

+61466015420; alison.wimms@resmed.com.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

AU (1)