SleepNCT06487650
The Development and Evaluation of Sleep Intervention for Perinatal Family
A study testing sleep intervention in people with Sleep and Psychological Distress, run by Taipei Medical University.
Trial summary
Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep, Psychological Distress, Perinatal Problems
- What is being tested?
- sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Sep 2026
- Phase
- Interventional
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-time mothers and their partners aged 20 and older;
- Currently 30 weeks gestation or more, singleton;
- insomnia severity index score greater than 10;
- living with a husband or partner;
- Both women and their partners are willing to participate in and adhere to the research protocol;
- be able to read and speak the Mandarin language
Who cannot join
- sleep disorders, depression or anxiety disorders;
- medical diseases with abnormal heart rate variability, or arrhythmia;
- taking medicines that may affect the autonomic nervous system or
- night shift workers;
- obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;
- infants with fetal deformity, or neonatal complications;
- no access to Internet resources
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.
Objectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.
Read more
Methods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.
Anticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.
Read the detailed description
The primary outcome is the severity of insomnia symptoms. The secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability will be collected. Infant sleep quality, infant feeding, and infant health outcomes will also be assessed. Data will be analyzed using descriptive and inferential statistics.
- Conditions
- Sleep, Psychological Distress, Perinatal Problems
- Being tested
- sleep intervention, Control group
- Keywords
- sleep quality, perinatal, depression, anxiety, infant sleep, infant health
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep interventionBehavioural
At the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention.
Control groupBehavioural
Participants in control group will follow standardized usual care and a perinatal health booklet
| Study group | Role | What they receive |
|---|---|---|
| sleep intervention | Experimental | Participants in the intervention group will receive both the standardized usual care and the sleep intervention. The intervention consists of sleep education, health professional support, and counseling. The intervention will be delivered from pregnancy to postpartum for mothers and fathers. Receives: Behavioral: sleep intervention |
| Control | Active comparator | Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The Chinese version of the Insomnia Severity Index (ISI) is used to measure the severity of insomnia symptoms, a higher score indicates more severe insomnia symptoms.
Measured: baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum
Secondary outcomes (14)
Sleep quality
The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI), will be used to measure sleep quality and sleep disturbance, higher score indicates worse sleep quality
Measured: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
Sleep duration using actigraphy
The Actiwatch will be used to collect objective data of sleep duration
Measured: baseline, postpartum 1 month, 3 months, and 6 months.
Sleep sleep onset latency using actigraphy
The Actiwatch will be used to collect objective data of sleep onset latency
Measured: baseline, postpartum 1 month, 3 months, and 6 months.
Sleep efficacy using actigraphy
The Actiwatch will be used to collect objective data of sleep efficacy
Measured: baseline, postpartum 1 month, 3 months, and 6 months.
Wake after sleep onset using actigraphy
The Actiwatch will be used to collect objective data of wake after sleep onset
Measured: baseline, postpartum 1 month, 3 months, and 6 months.
Infants sleep Questionnaire
Parents will be asked to rate their infant's sleep quality using the 19-item Brief Infant Sleep Questionnaire-Revised (BISQ-R). The BISQ will be used to assess sleep duration, duration of sleep by circadian rhythm, and night-time awakenings
Measured: postpartum 1 month, 3 months, 6 months, and 12-months
Depressive symptoms
Maternal and paternal depressive symptoms will be assessed using the Taiwanese version of the 10-item Edinburgh Postnatal Depression Scale (EPDS), a higher score indicated more severe symptoms.
Measured: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
Anxiety symptoms
The 20-item State Anxiety subscale of the State-Trait Anxiety Inventory (STAI) will be used to measure levels of anxiety symptoms in mothers and fathers, higher score presents more severe symptoms.
Measured: baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months
Heart rate variability (HRV) measures
The resting interbeat interval will be recorded
Measured: at baseline, postpartum 1 month, 3 months, and 6 months
Infant weight
Infants' body weight in gram will be measured by trained data collectors using an electronic scale specifically for infants
Measured: postpartum 3 months, 6 months, and 12-months
Infant height
Infants' height in cm will be measured by trained data collectors using an electronic scale specifically for infants
Measured: postpartum 3 months, 6 months, and 12-months
Infant development
Infant's social and emotional development will be assessed using the Taiwanese version of the Ages \& Stages Questionnaires: Social-Emotional-2 (ASQ: SE-2).
Measured: postpartum 3 months, 6 months, and 12-months
Infant feeding
Infant feeding methods will be measured using a self-report questionnaire. The feeding methods, including initiated breastfeeding within 24 hours after birth, and type of breastfeeding.
Measured: postpartum 1 month, 3 months, and 6 months, and 12 months
Satisfaction of sleep intervention
A structured questionnaire with a 5-point Likert scale will be used to collect the level of satisfaction of the sleep intervention upon completion of programs.
Measured: immediately after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study startDec 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Yu Kuo, Phd, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487650
- Sponsor's protocol ID
- N202204079
- Status last verified
- Jan 2025
- First submitted
- 13 Jun 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No