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Validation of a Ring-type Wearable Device

NCT05746338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-07-31

No results posted yet for this study

Summary

Study name: Validation of a Ring-type Wearable Device for Blood Oxygen Monitoring and Obstructive Sleep Apnea Syndrome Screening in Adult Chinese.

Objective: 1) To examine the accuracy of blood oxygen monitoring assessed via a ring-type wearable device in comparison to traditional finger clip pulse oximeter; 2) To assess the agreement between the ring-type wearable device and PSG monitor on OSAS screening.

Study design: Clinical diagnostic trial.

Study population: Individuals who are willing to participate in the study and sign the informed consent are considered to be eligible. Specific inclusion criterias include: 1) Agree to receive overnight polysomnography and wear the ring-type device at the same time; 2) At least 18 years old.

Sample size estimation: About 200 participants.

Timeline: Start of subjects' enrollment: Dec 2022; End of subjects' enrollment: Oct 2023; End of study: Oct 2023.

Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions

Interventions

DEVICE

Ring-type wearable device

The ring-type wearable device is a slim, lightweight smart ring that continuously tracks blood oxygen saturation and heart rate throughout the day.

DEVICE

Overnight polysomnography

Overnight polysomnography is the gold standard for diagnosing OSAS.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiguang Wang, MD, PhD · Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • China

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 NCT05746338 on ClinicalTrials.gov