Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial

Abstract

Background Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. Objective The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. Methods The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms. Results Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020. Conclusions This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women. Trial Registration ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon) International Registered Report Identifier (IRRID) DERR1-10.2196/12455

A Descriptive Comparative Pilot Study: Association Between Use of a Self-monitoring Device and Sleep and Stress Outcomes in Pregnancy

“…Although self-monitoring technology is gaining popularity in perinatal care in high- to middle-income countries, the associations between behavioral engagement in wearing devices and stress and sleep outcomes remain unclear. Studies examining the effectiveness of self-monitoring in pregnancy have revealed conflicting results; more should be investigated on the impact of self-monitoring activities on improved health outcomes 8,9,30,31 …”

“…Studies examining the effectiveness of self-monitoring in pregnancy have revealed conflicting results; more should be investigated on the impact of self-monitoring activities on improved health outcomes. 8 , 9 , 30 , 31 …”

“…Studies examining the effectiveness of self-monitoring in pregnancy have revealed conflicting results; more should be investigated on the impact of self-monitoring activities on improved health outcomes. 8,9,30,31 Wearable device monitoring and viewing personal data have shown to be highly effective and reliable for use in daily life of users and for research purposes. 11,23,32 Self-monitoring modalities support the collection of data about stress levels, sleep duration, and quality.…”

“…Because of a low frequency of contact visits during the early antenatal period, nonmedical concerns such as sleep disturbances and stress in early pregnancy have been historically left out of antenatal care 2 . It is now possible to monitor sleep quality and mental health states linked to stress during pregnancy using eHealth modalities 7–10 . A self-monitoring technology that provides insights into actual sleep patterns and stress responses could support pregnant persons toward building a greater bodily awareness in between antenatal clinic visits 11,12 …”

“…2 It is now possible to monitor sleep quality and mental health states linked to stress during pregnancy using eHealth modalities. [7][8][9][10] A self-monitoring technology that provides insights into actual sleep patterns and stress responses could support pregnant persons toward building a greater bodily awareness in between antenatal clinic visits. 11,12 If pregnant persons are given access to sleep and stress data collected using three-dimensional accelerometer, gyroscope, and biomarker signals including photoplethysmogram (PPG) and electrocardiogram through wearable recording devices and Bluetooth technology, they might be able to engage in lifestyle self-monitoring that stimulates their commitment to manage their sleep disturbances and levels of stress.…”