Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Effects of Regular Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedStudy Start
First participant enrolled
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 18, 2028
July 23, 2024
July 1, 2024
4 years
July 17, 2024
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bayley Scales of Infant and Toddler Development score
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 Outcomes (2)
Ages and Stages Questionnaires (ASQ) score
Children at 12 months
Ages and Stages Questionnaires (ASQ) score
Children at 6 months
Study Arms (2)
Nap
EXPERIMENTALThe experimental group will receive lifestyle recommendations to nap regularly
No nap
OTHERThe control group would not receive lifestyle recommendations to nap regularly
Interventions
Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200092, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun Huang, Ph.D.
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessors responsible for conducting the neurodevelopment tests are blinded to the group allocation.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 23, 2024
Study Start
August 19, 2024
Primary Completion (Estimated)
August 18, 2028
Study Completion (Estimated)
August 18, 2028
Last Updated
July 23, 2024
Record last verified: 2024-07