NCT05746338

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

January 31, 2023

Last Update Submit

July 30, 2024

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea syndromeBlood oxygen saturationRing-type wearable devicePolysomnographyValidation

Outcome Measures

Primary Outcomes (1)

  • Difference in the mean oxygen saturation

    1 night

Secondary Outcomes (5)

  • Difference in the lowest oxygen saturation

    1 night

  • Difference in the apnea-hypopnea index

    1 night

  • Difference in the oxygen desaturation index

    1 night

  • Difference in the hypoxic burden

    1 night

  • Agreement between the ring-type wearable device and PSG monitor on OSAS screening

    1 night

Study Arms (2)

Ring-type wearable device

EXPERIMENTAL

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.

Device: Ring-type wearable device

Polysomnography

ACTIVE COMPARATOR

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.

Device: Overnight polysomnography

Interventions

Ring-type wearable deviceDEVICE

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

Also known as: RingConn Smart Ring
Ring-type wearable device
Overnight polysomnographyDEVICE

Overnight polysomnography is the gold standard for diagnosing OSAS.

Also known as: PSG
Polysomnography

Eligibility Criteria

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

You may qualify if:

  • Agree to receive overnight polysomnography and wear the ring-type device at the same time;
  • At least 18 years old.

You may not qualify if:

  • Conditions that influencing overnight polysomnography monitoring, including receiving continuous positive airway pressure treatment and coexisting sleep disorders or insomnia;
  • Participants with cognitive dysfunction who are unable to provide informed consent;
  • Other circumstances that individuals are not appropriate for the study upon the investigator's judgment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jiguang Wang, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Shanghai Institute of Hypertension and the Department of Hypertension

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 27, 2023

Study Start

December 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

CN(1)