Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514833
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Regular Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1200 and 1500 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None