Gestational DiabetesNCT06687044
Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality
A study testing Sleep restriction, Cognitive therapy and Sleep principles discussion in people with Gestational Diabetes and Hypertension in Pregnancy, run by Jun Wei at 1 site in China.
Trial summary
During pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Hypertension in Pregnancy, Preterm Labor
- What is being tested?
- Sleep restriction, Cognitive therapy and Sleep principles discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2026
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: (1) Pregnant women aged 18-45 years. (2) Diagnosed with single or twin pregnancy within 12 weeks of pregnancy, report sleep quality problems, agree to participate in the study and sign the informed consent -
Exclusion Criteria:Have a prior serious underlying medical condition (e.g., diabetes, heart disease), mental illness, or other serious sleep disorder
-
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
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
During pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant women. Due to the coexistence of physiological, psychological, social and other complex factors during pregnancy, the incidence of sleep disorders in pregnant women is relatively high, up to 50%, and shows an increasing trend with the increase of gestational week. Not only seriously affect the quality of life of pregnant women, but also may lead to a variety of pregnancy complications, and even lead to adverse pregnancy outcomes. Therefore, early identification, timely diagnosis and treatment of sleep disorders during pregnancy are important measures to improve or even reverse adverse pregnancy outcomes. Although sleep disorders are more common and seriously harmful during pregnancy, people lack of understanding and attention to such diseases, and often regard them as normal clinical manifestations of pregnancy and neglect diagnosis and treatment.
Studies have shown that maternal sleep disorders are associated with hypertensive disorders during pregnancy, preterm birth, and gestational diabetes. Current research objects mainly focus on single pregnancy, twin related research is less.
The purpose of this study is to explore the perinatal sleep health of pregnant women with twin pregnancies, reduce the complications of pregnant women with twin pregnancies and improve the pregnancy outcomes of mothers and infants by improving sleep quality.
- Being tested
- Sleep restriction, Stimulation control, Cognitive therapy, Sleep principles discussion
- Medical subject headings
- Diabetes, Gestational, Hypertension, Pregnancy-Induced, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
Go to bed before 23pm
Stimulation controlBehavioural
Avoid drugs, alcohol, caffeine, and nicotine
Cognitive therapyBehavioural
Listen to 30 minutes of soothing music every night for 8 weeks
Sleep principles discussionBehavioural
The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction
| Study group | Role | What they receive |
|---|---|---|
| Sleep improvement Therapy group(CBT-I) | Experimental | Not described Receives: Behavioral: Sleep restriction; Behavioral: Stimulation control; Behavioral: Cognitive therapy |
| Control group (TAU) | Placebo comparator | Not described Receives: Behavioral: Sleep principles discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension in pregnancy
Pregnancy induced hypertension (PIH) is hypertension that occurs after 20 weeks of gestation in women with previously normal blood pressure.
Measured: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Gestational diabetes mellitus
Gestational diabetes mellitus (GDM) is defined as glucose intolerance of variable degree with onset or first recognition during pregnancy
Measured: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Preterm labor
Preterm labor is parturition that occurs when birth occurs between 28 weeks of gestation and 37 weeks
Measured: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
NICU infants
Neonatal NICU occupancy rate
Measured: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun Wei, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687044
- Sponsor's protocol ID
- Sleep improvement therapy
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality
- ClinicalTrials.gov ID
- NCT06687044
- Acronym / sponsor ID
- Sleep improvement therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jun WeiUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Nov 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.
During pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant women. Due to the coexistence of physiological, psychological, social and other complex factors during pregnancy, the incidence of sleep disorders in pregnant women is relatively high, up to 50%, and shows an increasing trend with the increase of gestational week. Not only seriously affect the quality of life of pregnant women, but also may lead to a variety of pregnancy complications, and even lead to adverse pregnancy outcomes. Therefore, early identification, timely diagnosis and treatment of sleep disorders during pregnancy are important measures to improve or even reverse adverse pregnancy outcomes. Although sleep disorders are more common and seriously harmful during pregnancy, people lack of understanding and attention to such diseases, and often regard them as normal clinical manifestations of pregnancy and neglect diagnosis and treatment.
Studies have shown that maternal sleep disorders are associated with hypertensive disorders during pregnancy, preterm birth, and gestational diabetes. Current research objects mainly focus on single pregnancy, twin related research is less.
The purpose of this study is to explore the perinatal sleep health of pregnant women with twin pregnancies, reduce the complications of pregnant women with twin pregnancies and improve the pregnancy outcomes of mothers and infants by improving sleep quality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep improvement Therapy group(CBT-I) | Experimental | Behavioral: Sleep restriction, Behavioral: Stimulation control, Behavioral: Cognitive therapy |
| Control group (TAU) | Placebo comparator | Behavioral: Sleep principles discussion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Sleep restrictionGo to bed before 23pm | Behavioural | Sleep improvement Therapy group(CBT-I) |
| Stimulation controlAvoid drugs, alcohol, caffeine, and nicotine | Behavioural | Sleep improvement Therapy group(CBT-I) |
| Cognitive therapyListen to 30 minutes of soothing music every night for 8 weeks | Behavioural | Sleep improvement Therapy group(CBT-I) |
| Sleep principles discussionThe principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction | Behavioural | Control group (TAU) |
Primary outcome
Hypertension in pregnancy
Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Pregnancy induced hypertension (PIH) is hypertension that occurs after 20 weeks of gestation in women with previously normal blood pressure.
Gestational diabetes mellitus
Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Gestational diabetes mellitus (GDM) is defined as glucose intolerance of variable degree with onset or first recognition during pregnancy
Preterm labor
Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Preterm labor is parturition that occurs when birth occurs between 28 weeks of gestation and 37 weeks
NICU infants
Time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Neonatal NICU occupancy rate
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 13 Nov 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction, Cognitive therapy and Sleep principles discussion in people with Gestational Diabetes and Hypertension in Pregnancy, run by Jun Wei 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?
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: enrolling by invitation, as of the sponsor's last update on 13 Nov 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension in pregnancy (time frame: From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)). The study lists 4 primary outcomes in all. 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 13 Nov 2024.