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

July 22, 2024 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Effects of Regular 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Xinhua Hospital Affiliated To Shanghai Jiao Tong University
        • Contact:
          • Guangyu Chen, Ph.D.
          • Phone Number: 86-21-25077485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nap
The experimental group will receive lifestyle recommendations to nap regularly
Behavioral: lifestyle recommendations to nap regularly
Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00
Other: No nap
The control group would not receive lifestyle recommendations to nap regularly
Other: No recommendations to nap regularly
No lifestyle recommendations to nap regularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

  1. Cognitive Development.
  2. Language Development.
  3. Motor Development.
  4. Social-Emotional Development.
  5. Adaptive Behavior.
Children at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ages and Stages Questionnaires (ASQ) score
Time Frame: Children at 12 months

ASQ typically evaluates the following areas:

  1. Communication.
  2. Gross Motor.
  3. Fine Motor.
  4. Problem Solving.
  5. Personal-Social.
Children at 12 months
Ages and Stages Questionnaires (ASQ) score
Time Frame: Children at 6 months

ASQ typically evaluates the following areas:

  1. Communication.
  2. Gross Motor.
  3. Fine Motor.
  4. Problem Solving.
  5. Personal-Social.
Children at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Yun Huang, Ph.D., Xinhua Hospital Affiliated To Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 19, 2024

Primary Completion (Estimated)

August 18, 2028

Study Completion (Estimated)

August 18, 2028

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-24-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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