NCT03783663

Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device

Completed NA Last updated 21 December 2018

What this trial tests

NA trial testing Misfit Shine 2 in Pregnancy in 24 participants. Completed in 27 August 2018.

Timeline

1 September 2017

Primary endpoint
18 July 2018

27 August 2018

Quick facts

Lead sponsor	University of Massachusetts, Amherst
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	24
Start date	1 September 2017
Primary completion	18 July 2018
Estimated completion	27 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Misfit Shine 2

Conditions studied

• Pregnancy — all drugs for Pregnancy →
• Sleep — all drugs for Sleep →

Sponsor

University of Massachusetts, Amherst

Who can join

18 and older, female only, with Pregnancy or Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women of lower socioeconomic status. Traditional clinical management of sleep disorders in pregnancy includes education and counseling on sleep hygiene and sleep positioning, dietary modifications, relaxation, iron supplementation, weight management, and physical activity, yet education-based behavioral interventions show minimal effectiveness for improving sleep among pregnant women. These methods typically do not incorporate objective self-monitoring, which is an important behavior change technique. In pregnancy, objective self-monitoring on a day-to-day basis is particularly important as sleep disorders may worsen as pregnancy progresses.

Computer-based personalized health monitoring (PHM) devices may serve as an effective tool with which pregnant women can self-manage sleep through incorporation of regular feedback. This strategy may be beneficial not only for women with pregnancy-associated sleep disorders but also for pregnant women with less severe sleep disruptions that experience daytime sleepiness, fatigue, and decreased quality of life. PHM devices have been used to promote weight loss, diet, and physical activity changes but no studies have specifically targeted sleep among pregnant women. The purpose of this pilot study is to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management with pregnant women using a PHM device, in order to refine the intervention for a larger, randomized trial.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Preliminary Efficacy of a Sleep Self-management Intervention Using a Personalized Health Monitoring Device during Pregnancy.
   Hsiao WH, Paterno MT, Iradukunda F, Hawkins' M. · · 2021 · cited 8× · PMID 33245245 · DOI 10.1080/15402002.2020.1851230
2. Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial.
   Hawkins M, Iradukunda F, Paterno M. · · 2019 · cited 5× · PMID 31144670 · DOI 10.2196/12455