Wearable DevicesNCT05636930
Accuracy Assessment of Sleep Monitoring Technology
An observational study of Wearable Devices, run by Shanshan Lu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wearable Devices
- What is being tested?
- Test the accuracy of the wearable device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: china
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanshan Lu
Jinan, Shandong, 250014
Shan S Lu, 15963126547, lushanshan819@163.com
About this study
Official title: To Evaluate the Accuracy of Sleep Parameters Evaluated by Wearable Sleep Devices
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
- Conditions
- Wearable Devices
- Being tested
- Test the accuracy of the wearable device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test the accuracy of the wearable deviceOther
No intervention was done for the subjects
| Study group | Role | What they receive |
|---|---|---|
| smart bracelet | Type and specification:FRA-B39 Receives: Other: Test the accuracy of the wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of sleep parameters of wearable devices
Sleep Latency,sleep efficiency
Measured: 8-10AM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wearable DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanshan Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shanshan Lu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636930
- Sponsor's protocol ID
- YXLL-KY-2002(052)
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Accuracy of Sleep Parameters Evaluated by Wearable Sleep Devices
- ClinicalTrials.gov ID
- NCT05636930
- Acronym / sponsor ID
- YXLL-KY-2002(052)
- Conditions
- Wearable Devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanshan LuUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smart bracelet | – | Other: Test the accuracy of the wearable deviceType and specification:FRA-B39 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- china
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test the accuracy of the wearable deviceNo intervention was done for the subjects | Other | smart bracelet |
Primary outcome
Accuracy of sleep parameters of wearable devices
Time frame: 8-10AM
Sleep Latency,sleep efficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wearable Devices, run by Shanshan Lu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ShanShanLu S Lu (86515963126547, lushanshan819@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of sleep parameters of wearable devices (time frame: 8-10AM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.