Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)

Pregnancy Clinical Trial

— I-SMART  

Official title:

Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05709327
• Other study ID #: 2021/2515
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: December 3, 2024

Study information

• Verified date: February 2023
• Source: KK Women's and Children's Hospital
• Contact: Kok Hian Tan, MD
• Phone: +6563941099
• Email: tan.kok.hian[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test the following hypotheses in a single-arm observational study in 70-100 healthy pregnant multi-ethnic women who will be followed-up from the first trimester of pregnancy to the third trimester of pregnancy.

Aim 1: To assess the applicability, acceptability and compliance with the use of a wearable smart ring together with smart digital devices (e.g., smart phone) during pregnancy.

Hypothesis 1: The investigators hypothesize that participants will respond favorably to the use of the smart ring to monitor their physical activity and sleep during pregnancy.

Aim 2: To assess the association between maternal characteristics (age, pre-pregnancy BMI, pregnancy weight gain, stress, anxiety and depression symptoms) with physical activity markers (energy expenditure, and step count) and sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability) collected from the smart ring in the second trimester of pregnancy.

Hypothesis 2: The investigators hypothesize that specific maternal characteristics will be associated with physical activity markers (energy expenditure, and step count), as well as sleep markers (duration, quality, sleep onset latency, wake after sleep onset, time in bed and heart rate variability).

Description:

Wearable sensor and other smart technologies may play an important part in the early detection of adverse pregnancy-related health events along with motivating improvement in patient and provider interactions for effective pregnancy health management. The use of wearable sensors, more specifically, wearable smart rings can potentially be used to offer remote, unobtrusive personalized care, encourage preventive care and provide the necessary context for self-help based just-intime adaptive interventions (feedback loops utilizing digital phenotyping data to trigger in-app interventions). Studies on the use of wearable smart rings and health outcomes are scarce, and currently there is no available data of the use of wearable smart rings together with smart digital devices (i.e., smart phone) for tracking pregnancy health in women. This study aims to be the first to generate preliminary pilot data to support it's use in this specific group of women.

An observational period for up to 37 weeks, single-center, one-armed intervention study involving 70-100 healthy pregnant women from a multi-ethnic population (Chinese, Malay, Indian, others) aged between 21 and 45 years.

All participants included into the study will be provided an Oura Ring to wear for the rest of the pregnancy period.

Data will be collected through questionnaires and each time a participant opens up their mobile application, the uploaded data will be automatically transferred via Bluetooth connection to the study database in the smart ring cloud service. The questionnaires include socio-economic factors, maternal anxiety and depression, maternal sleep, and maternal physical activity. The participants data will be collected from the moment join the study up till delivery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 3, 2024
• Est. primary completion date: December 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion criteria:

1. From the first to third trimester of pregnancy (4-39 weeks of gestational age)

2. Mobile phone's operating system supported by the smart ring application.

3. Aged 21 and above

Exclusion criteria:

1. Can't read or speak English

2. Below 21 years of age

3. Below or above gestational age limit

4. Limited mobility

5. Diagnosed with severe unstable mental conditions

6. Diagnosed with severe chronic disorders

7. Mobile device not compatible with smart ring

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Single-arm observational study where all participants in the study will be given a smart ring (Oura Ring) to wear throughout the duration of the study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and applicability of smart ring usage during pregnancy	The feasibility and applicability of a commercial smart ring (Oura Ring) use assessed by a feedback survey.	First trimester of pregnancy between 0-13 weeks gestational age
Primary	Feasibility and applicability of smart ring usage during pregnancy	The feasibility and applicability of a commercial smart ring (Oura Ring) use assessed by a feedback survey.	Second trimester of pregnancy between 14-26 weeks gestational age
Primary	Feasibility and applicability of smart ring usage during pregnancy	The feasibility and applicability of a commercial smart ring (Oura Ring) use assessed by a feedback survey.	Third trimester of pregnancy between 14-26 weeks gestational age
Secondary	Objective change in sleep quality across the entire pregnancy	The smart ring (Oura Ring) will issued to capture durations of deep sleep, rapid eye movement (REM) sleep, light sleep and nightly heart rate. Sleep Score ranges from 0-100, where a higher score reflects better sleep outcome.	up to 37 weeks from recruitment
Secondary	Self-reported change in sleep quality	Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.	First trimester of pregnancy between 0-13 weeks gestational age
Secondary	Self-reported change in sleep quality	Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.	Second trimester of pregnancy between 14-26 weeks gestational age
Secondary	Self-reported change in sleep quality	Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index Questionnaire (PSQI). Total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.	Third trimester of pregnancy between 14-26 weeks gestational age
Secondary	Objective change in physical activity across the entire pregnancy	The smart ring (Oura Ring) will be issued to capture durations of activity, inactivity and rest. Activity score ranges from 0-100, where a higher score reflects better balance between activity and rest.	up to 37 weeks from recruitment
Secondary	Self-reported change in physical activity	Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Data collected with International Physical Activity Questionnaire (IPAQ) can be reported as a continuous measure and reported as median metabolic equivalent of task (MET) minutes. A higher score will indicated higher physical activity involvement.	First trimester of pregnancy between 0-13 weeks gestational age
Secondary	Self-reported change in physical activity	Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Data collected with International Physical Activity Questionnaire (IPAQ) can be reported as a continuous measure and reported as median metabolic equivalent of task (MET) minutes. A higher score will indicated higher physical activity involvement.	Second trimester of pregnancy between 14-26 weeks gestational age
Secondary	Self-reported change in physical activity	Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Data collected with International Physical Activity Questionnaire (IPAQ) can be reported as a continuous measure and reported as median metabolic equivalent of task (MET) minutes. A higher score will indicated higher physical activity involvement.	Third trimester of pregnancy between 14-26 weeks gestational age
Secondary	Anxiety and depression symptoms	The Depression Anxiety Stress Scales (DASS) will be used to capture self-reported anxiety and depression symptoms across pregnancy. The minimum score is 0 and the maximum score is 63. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.	First trimester of pregnancy between 0-13 weeks gestational age
Secondary	Change in anxiety and depression symptoms across the first, second and third trimesters	The Depression Anxiety Stress Scales (DASS) will be used to capture self-reported anxiety and depression symptoms across pregnancy. The minimum score is 0 and the maximum score is 63. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.	Second trimester of pregnancy between 14-26 weeks gestational age
Secondary	Change in anxiety and depression symptoms across the first, second and third trimesters	The Depression Anxiety Stress Scales (DASS) will be used to capture self-reported anxiety and depression symptoms across pregnancy. The minimum score is 0 and the maximum score is 63. A higher score on the DASS indicates greater severity or frequency of these negative emotional symptoms.	Third trimester of pregnancy between 14-26 weeks gestational age