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

NCT05709327 | Recruiting DMC

• 1 other identifier: 2021/2515
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pregnancy

Outcome Measures

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.

  At the end of pregnancy

Secondary Outcomes (11)

• Objective change in sleep quality across the entire pregnancy

  up to 37 weeks from recruitment

• Self-reported change in sleep quality

  First trimester of pregnancy between 0-12 weeks gestational age

• Self-reported change in sleep quality

  Second trimester of pregnancy between 13-27 weeks gestational age

• Self-reported change in sleep quality

  Third trimester of pregnancy between 28-40 weeks gestational age

• Objective change in physical activity across the entire pregnancy

  up to 37 weeks from recruitment

Study Arms (1)

Single-arm observational study

OTHER

All participants in the study will be provided a smart ring to wear for the entire duration of the pregnancy.

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

Interventions

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

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.

Single-arm observational study

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Healthy pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Can't read or speak English
• Below 21 years of age
• Below or above gestational age limit
• Limited mobility
• Diagnosed with severe unstable mental conditions
• Diagnosed with severe chronic disorders
• Mobile device not compatible with smart ring

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Study Officials

• Kok Hian Tan, MD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kok Hian Tan, MD

CONTACT

+6563941099; tan.kok.hian@singhealth.com.sg

Phaik Ling, Elaine Quah, PhD

CONTACT

+6597732543; quah.phaik.ling@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-arm observational study

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 2, 2023
• Study Start: September 3, 2023
• Primary Completion: December 3, 2025
• Study Completion: December 3, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)