Accuracy Assessment of Sleep Monitoring Technology

Recruiting

• Conditions: Wearable Devices
• Interventions: Other: Test the accuracy of the wearable device

• Registration Number: NCT05636930
• Lead Sponsor: Shanshan Lu

Brief Summary

As a necessary process of life, sleep is an important link for the body to recover, integrate and consolidate memory. However, the fast pace of life in modern society and people's bad living habits are easy to cause sleep disorders. Sleep disorders are often the main factors that induce or aggravate cardiovascular and cerebrovascular diseases. Sleep staging is an important basis for sleep quality assessment and related disease diagnosis. At present, electroencephalography (EEG) has become the gold standard for judging sleep stages. However, this kind of method requires long-term contact of multiple electrodes with the human body, which is easy to affect the natural sleep of the subjects, so it is not suitable for sleep monitoring in home environment. Studies have shown that sleep is related to the regulation of autonomic nervous system, and heart rate variability (HRV) in sleep also shows periodic changes similar to brain waves. Smartwatch/bracelet can continuously monitor the user's pulse wave and acceleration data comfortably and without feeling. HRV features can be extracted using pulse wave data, and then sleep staging can be realized based on the correlation between HRV and brain waves, and sleep quality can be evaluated. Therefore, healthy sleep research aims to use smart devices to achieve sleep monitoring in the home environment and improve people's sleep quality

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-26
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-23
• Last Update Submitted: 2022-11-23
• Study First Posted: 2022-12-05
• Last Update Posted: 2022-12-05
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• a. Adults aged 18 and above and under the age of 60; The age of the subjects was divided into two age groups: 18-44, 45-60, and the ratio between the two groups was 1:1.2-1:0.8. The ratio of female to male is between 1:1.1 and 1:1.0; b. No patients with serious cardiovascular and cerebrovascular diseases, moderate degree of depression, anxiety disorder or severe apnea; HAMD<=20;HAMA <=13;AHI< 30 c. Subjects did not drink alcohol or take sleep intervention drugs during the program; d. People with sleep disorders and insomnia can be included in the subjects, but the total number is no more than 50%, and should be clearly marked; e. Having Chinese nationality and residing in China; f. Agree to be monitored by PSG and wear wearable devices; Voluntary entry, informed consent or consent to privacy agreement.

Exclusion Criteria

• a. Patients with a history of depression, anxiety and other mental disorders; HAMD>20;HAMA>13 b. Patients with existing atherosclerotic cardiovascular diseases, such as coronary heart disease and severe peripheral atherosclerotic disease; c. age >60 d. Patients with obstructive sleep apnea (AHI >30); Use of drugs or substances affecting the central nervous system in the preceding 2 weeks.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
smart bracelet	Test the accuracy of the wearable device	Type and specification:FRA-B39

Primary Outcome Measures

Name	Time	Method
Accuracy of sleep parameters of wearable devices	8-10AM	Sleep Latency,sleep efficiency

Trial Locations

Locations (1)

Shanshan Lu; 🇨🇳 Jinan, Shandong, China