Accuracy Assessment of Sleep Monitoring Technology

Wearable Devices Clinical Trial

Official title:

To Evaluate the Accuracy of Sleep Parameters Evaluated by Wearable Sleep Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636930
• Other study ID #: YXLL-KY-2002(052)
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: Qianfoshan Hospital
• Contact: ShanShanLu S Lu
• Phone: 86515963126547
• Email: lushanshan819[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Wearable Devices

Intervention

Other:
• Test the accuracy of the wearable device
No intervention was done for the subjects

Locations

Country	Name	City	State
China	Shanshan Lu	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shanshan Lu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of sleep parameters of wearable devices	Sleep Latency,sleep efficiency	8-10AM