NCT06930404

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 9, 2025

Last Update Submit

April 9, 2025

Conditions

Keywords

diagnosisscreening

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

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

People being investigated for obstructive sleep apnea

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDisease

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Central Study Contacts

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

April 20, 2025

Primary Completion

August 30, 2025

Study Completion

October 30, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04