Validation of a Ring-type Wearable Device

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Overnight polysomnography; Device: Ring-type wearable device

• Registration Number: NCT05746338
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-02-27
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polysomnography	Overnight 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.
Ring-type wearable device	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.

Primary Outcome Measures

Name	Time	Method
Difference in the mean oxygen saturation	1 night

Secondary Outcome Measures

Name	Time	Method
Difference in the oxygen desaturation index	1 night
Difference in the apnea-hypopnea index	1 night
Difference in the lowest oxygen saturation	1 night
Agreement between the ring-type wearable device and PSG monitor on OSAS screening	1 night	Sensitivity, specificity, positive predictive value, negative predictive value and area under the ROC curve were used to describe the agreement between the ring-type wearable device and PSG monitor on OSAS screening
Difference in the hypoxic burden	1 night

Trial Locations

Locations (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China