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

NCT03783663 | Completed

• 1 other identifier: 2017-3846
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Sleep

Outcome Measures

Primary Outcomes (3)

• Number of participants that remain in the study for the entire study period for the intervention and control groups.

  To assess feasibility of the study, we will calculate the number and percentage of participants in both groups that remain in the study for the entire study period. The study will be considered as feasible if at least 80% of participants remain in the study for its entirety.

  24 to 36 weeks gestation of pregnancy

• Percentage of days during which the Misfit Shine 2 is worn by participants in the intervention group.

  To assess feasibility of the study, for women in the intervention group, we will calculate the proportion of the number of days the Misfit Shine 2 is worn during the study period. We will consider the intervention as feasible if participants wear the Misfit Shine 2 at least 80% of days during the study period.

  24 to 36 weeks gestation of pregnancy

• Participant satisfaction with the sleep education (both groups) and with the Misfit Shine 2 (intervention group only) will be assessed through qualitative interviews.

  At 36 weeks gestation, all participants will be asked to take part in a semi-structured qualitative interview in which open-ended questions will be asked about their sleep patterns, barriers and facilitators of sleep, and whether the sleep education was deemed helpful. Intervention group participants will additionally be asked questions about the experience wearing the MisFit Shine 2, their like and dislikes, and whether they believe it would be helpful to other pregnant women.

  36 weeks gestation of pregnancy.

Secondary Outcomes (5)

• Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (PSQI)

  24 to 36 weeks gestation of pregnancy

• Sleep disturbances as measured by the PROMIS SF v1.0-Sleep Distrubance 6a

  24 to 36 weeks gestation of pregnancy

• Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale

  24 to 36 weeks gestation of pregnancy

• Fatigue as measured by the PROMIS Fatigue Short Form 4a

  24 to 36 weeks gestation of pregnancy

• Depressive symptoms as measured by the PROMIS Depression Short Form 6a and the Edinburgh Postnatal Depression Scale

  24 to 36 weeks gestation of pregnancy

Study Arms (2)

Sleep education plus Misfit Shine 2

EXPERIMENTAL

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.

Behavioral: Misfit Shine 2

sleep education only

NO INTERVENTION

This arm receives only sleep education from the study nurse.

Interventions

Misfit Shine 2 BEHAVIORAL

The intervention group was given a Misfit Shine 2 to monitor sleep throughout the 12-week intervention period. Participants were instructed to wear the device on the wrist, which is better for capturing sleep than the other wear locations. Participants were instructed on how to self-monitor total sleep time and select a goal for that behavior. Further, participants were asked to view feedback on their sleep time daily on the Misfit smartphone app, which they used to monitor their progress toward achieving their behavioral goals.

Sleep education plus Misfit Shine 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be age ≥ 18
• to \<24 completed weeks gestation of pregnancy
• \) 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.

You may not qualify if:

• pre-existing diabetes mellitus or hypertension
• diagnosed sleep disorder

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead
• University of Pittsburgh: collaborator

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

Related Publications (1)

• Hawkins M, Iradukunda F, Paterno M. Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 May 29;8(5):e12455. doi: 10.2196/12455.

  PMID: 31144670 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel arm superiority, pilot feasibility randomized controlled trial

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 21, 2018
• Study Start: September 1, 2017
• Primary Completion: July 18, 2018
• Study Completion: August 27, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)