Validation of a Ring-type Wearable Device

NCT ID: NCT05746338

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-09-30

Brief 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.

Detailed Description

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

Rationale: Obstructive sleep apnoea syndrome (OSAS) is a common chronic sleep-related breathing disorder characterized by repetitive upper airway collapse during sleep, which causes sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. Previous studies have identified that OSAS is significantly correlated with the risk of cardiovascular and cerebrovascular diseases. Overnight polysomnography (PSG) is the gold standard for diagnosing OSAS at present. However, PSG monitoring requires professional technicists and a lot of channels, which brings inconvenience to both patients and doctors. Wearable devices are growing in popularity and become comfortable, lightweight and technologically advanced for tracking sleep and daily activity.

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.

Data collections: 1) Data on demographic and clinical characteristics were collected using a questionnaire; 2) Data on blood oxygen saturation and sleep apnea-related parameters were measured by both PSG monitoring and the ring-type wearable device.

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

Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ring-type wearable device

The ring-type wearable device achieved continuous monitoring of blood oxygen saturation during sleep and established a OSAS screening algorithm based on oxygen saturation, which might become a complement to polysomnography.

Group Type: EXPERIMENTAL

Ring-type wearable device

Intervention Type: DEVICE

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

Polysomnography

Overnight polysomnography (PSG) monitor was used as the gold standard to: 1) examine the accuracy of blood oxygen monitoring assessed via a ring-type wearable device in comparison to traditional finger clip pulse oximeter; 2) assess the agreement between the ring-type wearable device and PSG monitor on OSAS screening.

Group Type: ACTIVE_COMPARATOR

Overnight polysomnography

Intervention Type: DEVICE

Overnight polysomnography is the gold standard for diagnosing OSAS.

Interventions

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.

Intervention Type: DEVICE

Overnight polysomnography

Overnight polysomnography is the gold standard for diagnosing OSAS.

Intervention Type: DEVICE

Other Intervention Names

RingConn Smart Ring; PSG

Eligibility Criteria

Inclusion Criteria

1. Agree to receive overnight polysomnography and wear the ring-type device at the same time;

2. At least 18 years old.

Exclusion Criteria

1. Conditions that influencing overnight polysomnography monitoring, including receiving continuous positive airway pressure treatment and coexisting sleep disorders or insomnia;

2. Participants with cognitive dysfunction who are unable to provide informed consent;

3. Other circumstances that individuals are not appropriate for the study upon the investigator's judgment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ji-Guang Wang

Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiguang Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

RING

Identifier Type: -

Identifier Source: org_study_id