Clinical trial NCT03783663: Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device
Official title: Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Sleep
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2018-12-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel arm superiority, pilot feasibility randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

1. be age ≥ 18
2. 14 to \<24 completed weeks gestation of pregnancy

2) 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

Primary outcomes:
measure: Number of participants that remain in the study for the entire study period for the intervention and control groups.
timeFrame: 24 to 36 weeks gestation of pregnancy
measure: Percentage of days during which the Misfit Shine 2 is worn by participants in the intervention group.
timeFrame: 24 to 36 weeks gestation of pregnancy
measure: Participant satisfaction with the sleep education (both groups) and with the Misfit Shine 2 (intervention group only) will be assessed through qualitative interviews.
timeFrame: 36 weeks gestation of pregnancy.
Secondary outcomes:
measure: Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 24 to 36 weeks gestation of pregnancy
measure: Sleep disturbances as measured by the PROMIS SF v1.0-Sleep Distrubance 6a
timeFrame: 24 to 36 weeks gestation of pregnancy
measure: Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale
timeFrame: 24 to 36 weeks gestation of pregnancy
measure: Fatigue as measured by the PROMIS Fatigue Short Form 4a
timeFrame: 24 to 36 weeks gestation of pregnancy
measure: Depressive symptoms as measured by the PROMIS Depression Short Form 6a and the Edinburgh Postnatal Depression Scale
timeFrame: 24 to 36 weeks gestation of pregnancy
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
Study officials:
References:
citation: 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.