Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorKK Women's and Children's Hospital
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
From the first to third trimester of pregnancy (4-39 weeks of gestational age)
Mobile phone's operating system supported by the smart ring application.
Aged 21 and above
Disqualifiers
Can't read or speak English
Below 21 years of age
Below or above gestational age limit
Limited mobility
Trial design
Design model
Single group
Treatments tested in this trial
Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Other interventionSingle-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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single-arm observational studyOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At the end of pregnancySecondary outcomes
1
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.
Time frame
up to 37 weeks from recruitment2
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.
Time frame
First trimester of pregnancy between 0-12 weeks gestational age3
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.
Time frame
Second trimester of pregnancy between 13-27 weeks gestational age4
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.
Time frame
Third trimester of pregnancy between 28-40 weeks gestational ageSponsors and contacts
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Source ClinicalTrials.gov