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

University of Massachusetts, Amherst logo

University of Massachusetts, Amherst

Status

Completed

Conditions

Sleep
Pregnancy

Treatments

Behavioral: Misfit Shine 2

Study type

Interventional

Funder types

Other

Identifiers

NCT03783663
2017-3846

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: at time of recruitment (t0) women must:

  1. be age ≥ 18
  2. 14 to <24 completed weeks gestation of pregnancy
  1. have no known maternal or fetal complications 3) have a smartphone compatible with the study PHM device 4) have internet access 5) be English speaking 6) be receiving prenatal care.

Exclusion Criteria:

  1. pre-existing diabetes mellitus or hypertension
  2. diagnosed sleep disorder

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Sleep education plus Misfit Shine 2
Experimental group
Description:
This arm receives sleep education from the study nurse and also receives a Misfit Shine 2 to wear for 12 weeks to self-monitor sleep.
Treatment:
Behavioral: Misfit Shine 2
sleep education only
No Intervention group
Description:
This arm receives only sleep education from the study nurse.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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