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NCT Number: NCT06514833

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

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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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200092, China

Location contact

Guangyu Chen, Ph.D.

CONTACT

86-21-25077485

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.

Treatment and study plan

lifestyle recommendations to nap regularly

Behavioral

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

No recommendations to nap regularly

Other

No lifestyle recommendations to nap regularly

Primary outcomes

  1. Bayley Scales of Infant and Toddler Development score

    Time frame: Children at 24 months

    The Bayley Scales of Infant and Toddler Development (Bayley-III) evaluates five key developmental domains:

    • Cognitive Development.
    • Language Development.
    • Motor Development.
    • Social-Emotional Development.
    • Adaptive Behavior.

Secondary outcomes

  1. Ages and Stages Questionnaires (ASQ) score

    Time frame: Children at 12 months

    ASQ typically evaluates the following areas:

    • Communication.
    • Gross Motor.
    • Fine Motor.
    • Problem Solving.
    • Personal-Social.
  2. Ages and Stages Questionnaires (ASQ) score

    Time frame: Children at 6 months

    ASQ typically evaluates the following areas:

    • Communication.
    • Gross Motor.
    • Fine Motor.
    • Problem Solving.
    • Personal-Social.

Study contacts

Contact information is provided by the study sponsor or research team.

Yun Huang, Ph.D.

CONTACT

[email protected]

86-021-25078999

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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