Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2028-08-18

Brief Summary

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To examine the effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment, the researchers will recruit 80 pregnant women with sleep disturbances. These women will receive lifestyle recommendations to nap regularly and will choose whether or not to nap. The participants will wear wrist-worn accelerometers to record their 24-hour sleep patterns for seven consecutive days during the early, middle, and late stages of pregnancy. The neurodevelopment of their offspring will be assessed at 6 months, 12 months, 18 months, and 2 years of age.

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Detailed Description

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Participants will be recruited based on the Early Life Plan Project, an ongoing hospital-based prospective birth cohort study. Pregnant women will be recruited at the time of booking for prenatal care. The sleep patterns of pregnant women will be assessed at 12-16 weeks of gestation using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Women with a PSQI score greater than 5 and who self-report as not being habitual nappers in the last 3 months will be recruited. These women will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00. Whether they adopt this lifestyle change or the actual duration of their naps will be entirely up to the participants. An Actiwatch will be given to the participants during early pregnancy (12-14 weeks), mid-pregnancy (22-24 weeks), and late pregnancy (29-32 weeks). Instructions will be included on how to wear the watch, with participants advised to wear it on the non-dominant wrist continuously for 7 days, except when swimming or bathing. In addition to the Actiwatch, participants will complete a sleep questionnaire during early pregnancy (12-14 weeks), mid-pregnancy (26-27 weeks), and late pregnancy (35-37 weeks) to subjectively assess their nighttime sleep and napping over the past month. The neurodevelopment of the participants' offspring will be followed up and assessed using the Bayley Scales of Infant and Toddler Development at 6 months, 12 months, 18 months, and 2 years of age.

Conditions

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Sleep

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Assessors responsible for conducting the neurodevelopment tests are blinded to the group allocation.

Study Groups

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Nap

The experimental group will receive lifestyle recommendations to nap regularly

Group Type EXPERIMENTAL

lifestyle recommendations to nap regularly

Intervention Type BEHAVIORAL

Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00

No nap

The control group would not receive lifestyle recommendations to nap regularly

Group Type OTHER

No recommendations to nap regularly

Intervention Type OTHER

No lifestyle recommendations to nap regularly

Interventions

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lifestyle recommendations to nap regularly

Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00

Intervention Type BEHAVIORAL

No recommendations to nap regularly

No lifestyle recommendations to nap regularly

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Pregnant women with a PSQI score greater than 5 at enrollment.
2. Not a habitual napper in the past 3 months (defined as napping 5 or more days per week on average for the past month).