SleepNCT06514833
Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
A study testing lifestyle recommendations to nap regularly and No recommendations to nap regularly in people with Sleep, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- lifestyle recommendations to nap regularly and No recommendations to nap regularly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2024to 18 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200092
Guangyu Chen, Ph.D., 86-21-25077485
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep
- Being tested
- lifestyle recommendations to nap regularly, No recommendations to nap regularly
- Keywords
- Sleep disturbance, Neurodevelopment
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle recommendations to nap regularlyBehavioural
Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00
No recommendations to nap regularlyOther
No lifestyle recommendations to nap regularly
| Study group | Role | What they receive |
|---|---|---|
| Nap | Experimental | The experimental group will receive lifestyle recommendations to nap regularly Receives: Behavioral: lifestyle recommendations to nap regularly |
| No nap | Other | The control group would not receive lifestyle recommendations to nap regularly Receives: Other: No recommendations to nap regularly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development score
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.
Measured: Children at 24 months
Secondary outcomes (2)
Ages and Stages Questionnaires (ASQ) score
ASQ typically evaluates the following areas:
- Communication.
- Gross Motor.
- Fine Motor.
- Problem Solving.
- Personal-Social.
Measured: Children at 12 months
Ages and Stages Questionnaires (ASQ) score
ASQ typically evaluates the following areas:
- Communication.
- Gross Motor.
- Fine Motor.
- Problem Solving.
- Personal-Social.
Measured: Children at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start19 Aug 2024 (estimated)
- Primary completion18 Aug 2028 (estimated)
- Study completion18 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Huang, Ph.D., Principal investigator, Xinhua Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514833
- Sponsor's protocol ID
- XH-24-006
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regular Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
- ClinicalTrials.gov ID
- NCT06514833
- Acronym / sponsor ID
- XH-24-006
- Conditions
- Sleep
- Keywords
- Sleep disturbance, Neurodevelopment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 19 Aug 2024 (estimated)
- Primary completion
- 18 Aug 2028 (estimated)
- Study completion
- 18 Aug 2028 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nap | Experimental | Behavioral: lifestyle recommendations to nap regularlyThe experimental group will receive lifestyle recommendations to nap regularly |
| No nap | Other | Other: No recommendations to nap regularlyThe control group would not receive lifestyle recommendations to nap regularly |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle recommendations to nap regularlyParticipants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00 | Behavioural | Nap |
| No recommendations to nap regularlyNo lifestyle recommendations to nap regularly | Other | No nap |
Primary outcome
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.
2 secondary outcomes
Ages and Stages Questionnaires (ASQ) score
Time frame: Children at 12 months
Ages and Stages Questionnaires (ASQ) score
Time frame: Children at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yun Huang, Ph.D. principal investigator
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle recommendations to nap regularly and No recommendations to nap regularly in people with Sleep, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Huang, Ph.D. (86-021-25078999, yunhuang.pku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant and Toddler Development score (time frame: Children at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.