NCT05709327

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

KK Women's and Children's Hospital·ClinicalTrials.gov·otherNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Pregnancy
Drug/Device/Intervention
Integrating Smart Ring Wearable Technology in Pregnancy Health Monitoring (I-SMART)
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
KK Women's and Children's Hospital
Timeline & enrollment
Phase
N/A
Start date
Apr 03, 2023
End date
Dec 03, 2024
Enrollment
100 participants
Primary outcome

Feasibility and applicability of smart ring usage during pregnancy,Feasibility and applicability of smart ring usage during pregnancy,Feasibility and applicability of smart ring usage during pregnancy

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).

ICD-10 classifications
Pregnancy confirmedPregnancy-related condition, unspecifiedAbdominal pregnancyPregnancy, not (yet) confirmedOvarian pregnancy
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05709327
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05709327 through Pure Global AI's free database. This phase not specified trial is sponsored by KK Women's and Children's Hospital and is currently Not yet recruiting. The study focuses on Pregnancy. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.