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Recruiting
NCT05746338
Validation of a Ring-type Wearable Device
Conditions: Obstructive Sleep Apnea
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: Shanghai Jiao Tong University School of Medicine
Location: China
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.
Eligibility Criteria
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:Agree to receive overnight polysomnography and wear the ring-type device at the same time;At least 18 years old.Exclusion Criteria: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.
Source: ClinicalTrials.gov (NCT05746338). StuddyBuddy aggregates publicly available trial information.