Pregnancy Sleep Coaching for Sleep in Pregnancy

Overseen By Louise O'Brien, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Less than 28 weeks pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines changes in sleep patterns for pregnant women and assesses whether a sleep monitor can improve sleep habits. Participants will wear either an active device, the Active Pregnancy Coach, which provides sleep coaching, or a deactivated version for comparison. The trial seeks women who are at least 28 weeks pregnant, receiving prenatal care at Michigan Medicine, and own a smartphone. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance sleep health for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this sleep monitoring device is safe for pregnant women?

Research has shown that personal health devices, such as the Active Pregnancy Coach, are generally safe for pregnant women. Studies indicate that these devices can improve sleep duration and quality without causing harm. Participants using similar devices have not reported any serious side effects, suggesting that the Active Pregnancy Coach is likely well-tolerated. Additionally, non-drug methods, like sleep coaching, are known to enhance sleep without the risks associated with medications. Therefore, the Active Pregnancy Coach appears to be a safe option for better sleep during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to improving sleep during pregnancy through personalized sleep coaching. Unlike traditional methods like sleep hygiene education or medication, this trial uses an active pregnancy coach device designed to support better sleep habits throughout pregnancy. The potential of this device lies in its interactive nature, offering real-time feedback and personalized guidance, which could lead to more effective and tailored sleep solutions for expectant mothers. This innovative technology aims to address sleep issues more dynamically and individually than current standard practices.

What evidence suggests that this sleep coaching device is effective for improving sleep in pregnancy?

Research shows that the Active Pregnancy Coach, available to participants in this trial, can help pregnant women sleep better. One study found that a home-based program called the Sleep Enhancement Training System for Pregnancy helped women sleep longer and wake up less during the night. Non-drug methods like this have improved how pregnant women feel about their sleep. Combining physical activity with sleep coaching has improved sleep, especially in early pregnancy. Overall, these findings suggest that the Active Pregnancy Coach could be a useful tool for enhancing sleep during pregnancy. Meanwhile, another group in this trial will use a Deactivated Pregnancy Coach to compare outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Louise O'Brien, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for pregnant women who are at least 28 weeks along and receiving prenatal care at Michigan Medicine. Participants must own an Android or iPhone smartphone. Women less than 28 weeks pregnant, without a smartphone, or getting prenatal care outside of Michigan Medicine cannot join.

Inclusion Criteria

You need to have a smartphone that runs on Android or iPhone operating system.

Receiving pre-natal care at Michigan Medicine

At least 28 weeks pregnant

Exclusion Criteria

I am less than 28 weeks pregnant.

You don't have a smartphone.

Receiving pre-natal care external to Michigan Medicine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants wear the device for a 3-day run-in period to acclimate to the study conditions

3 days

Treatment

Participants wear either an active or deactivated device for the remainder of pregnancy to monitor sleep behaviors

12 weeks

Follow-up

Participants are monitored for sleep behavior changes and outcomes until delivery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Pregnancy Coach
• Deactivated Pregnancy Coach

Trial Overview

The study is testing two types of pregnancy coaches: one active and one deactivated. Researchers want to see how these devices affect sleep positions and movements during the night in late-stage pregnancy, aiming to improve sleep behaviors.

How Is the Trial Designed?

Group I: Active device Experimental Treatment 1 Intervention

Wear active device for remainder of pregnancy (including 3 day run-in period)

Group II: Deactivated device Active Control 1 Intervention

Wear deactivated pregnancy coach device for the remainder of pregnancy.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A 10-week gymnastics program for 132 healthy pregnant women helped reduce the deterioration of sleep quality and psycho-emotional status compared to a control group that did not exercise.

While sleep quality generally declined during pregnancy for both groups, those who participated in the gymnastics program experienced less worsening of specific sleep issues like restless sleep and daytime tiredness, highlighting the benefits of regular physical activity during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a gymnastics program on sleep characteristics in pregnant women. Kocsis, I., Szilágyi, T., Turos, J., et al.[2017]

A study involving 219 pregnant women found that structured exercise training significantly improved sleep quality compared to standard prenatal care, particularly at 28 and 34 weeks of gestation.

Physical activity interventions also reduced sedentary time, with exercise leading to lower daily sedentary hours compared to both standard care and motivational counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Two Physical Activity Interventions on Sleep and Sedentary Time in Pregnant Women. Alomairah, SA., Knudsen, SP., Roland, CB., et al.[2023]

Over half of the pregnant women (55.3%) reported sleep disorders in the first trimester, with this number increasing to 65.8% in the third trimester, indicating that sleep issues are common and worsen as pregnancy progresses.

The study highlights the importance of prenatal care as a key opportunity for healthcare providers to educate and guide pregnant women on sleep hygiene, especially given the significant increase in sleep problems during the later stages of pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in pregnancy quarters: a longitudinal study. Felix, NAR., Ceolim, MF.[2022]

This ongoing pilot randomized controlled trial is investigating the feasibility and acceptability of using a personal health monitor (PHM) device to improve sleep quality among pregnant women, with a focus on those at 24 weeks gestation over a 12-week period.

The study aims to assess not only the effectiveness of the PHM device in enhancing sleep but also its impact on related factors such as daytime sleepiness, fatigue, and depressive symptoms, potentially paving the way for larger-scale interventions in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.[2020]

In a study of 251 Hispanic pregnant women, household and caregiving activities were linked to higher odds of very poor sleep quality and shorter sleep duration, suggesting these activities may negatively impact sleep during pregnancy.

Conversely, occupational physical activity was associated with lower odds of very poor sleep quality, indicating that certain types of physical activity may promote better sleep among pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Sleep Quality and Duration During Pregnancy Among Hispanic Women: Estudio PARTO. Hawkins, M., Marcus, B., Pekow, P., et al.[2021]

The Sleep Improvement Protocol for Antepartum Patients (SIP-AP) was found to be feasible and effective in reducing sleep disturbances among hospitalized pregnant women, with the intervention group reporting significantly lower disturbance scores compared to controls (53.1 vs. 71.9).

Both groups had similar sleep durations of about 7 hours, but the intervention group experienced fewer symptoms affecting sleep, indicating that the SIP-AP protocol may enhance sleep quality in high-risk antepartum patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study. Lee, KA., Gay, CL.[2019]

Pregnant women who met physical activity guidelines reported better sleep quality, although objective sleep measures did not show significant differences between active and inactive groups.

Meeting dietary protein guidelines was linked to longer sleep duration and less wakefulness after sleep onset, suggesting that both physical activity and nutrition play important roles in improving sleep during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Meeting Exercise and Nutrition Guidelines on Sleep during Pregnancy. McCarthy, TA., Velez, SM., Buckman, JF., et al.[2023]

A pilot study involving 24 pregnant women showed that using a personal health monitoring (PHM) device for 12 weeks was feasible, with 83% of participants retained throughout the intervention and follow-up.

Most participants were willing to engage in sleep intervention research, as 91% wore the device for at least ten weeks, indicating potential for effective self-monitoring of sleep during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a pilot, randomized controlled trial using a personalized health monitoring device with pregnant women for behavioral sleep research. Paterno, MT., Iradukunda, F., Hawkins, M.[2021]

In a randomized controlled trial involving 210 sleep-deprived pregnant women, the use of eye masks and earplugs (EMEP) significantly increased night sleep duration by an average of 23 minutes compared to a sleep hygiene advice leaflet (AL), which only increased sleep duration by 10 minutes.

EMEP also improved sleep quality more effectively than AL, as indicated by a significant reduction in the Pittsburgh Sleep Quality Index score, while there were no significant differences in labor and neonatal outcomes between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye-mask and earplugs compared with sleep advice leaflet to improve night sleep duration in pregnancy: a randomized controlled trial. Gan, F., Sooriappragasarao, M., Sulaiman, S., et al.[2023]

The home-based Sleep Enhancement Training System for Pregnancy significantly improved sleep duration and reduced sleep disruption in pregnant women, with the intervention group averaging 430 minutes of sleep compared to 420 and 417 minutes in the control groups.

Postpartum, the intervention group continued to experience better sleep outcomes, averaging 446 minutes of sleep and less disruption compared to 390 and 370 minutes in the control groups, demonstrating the program's effectiveness during a challenging time for sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Enhancement Training for Pregnant Women. Lee, KA., Gay, CL., Alsten, CR.[2021]

Poor sleep quality during pregnancy is common among Ghanaian women and is linked to serious complications, such as pre-eclampsia, with snoring during pregnancy increasing the risk by 3.5 times.

Sleeping in a supine position (on the back) during pregnancy is associated with a higher risk of low birth weight (5 times more likely) and stillbirth (8 times more likely), indicating that maternal sleep practices can significantly impact fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Owusu, JT., Anderson, FJ., Coleman, J., et al.[2022]

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