ChronotypeNCT06413784
Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women
A study testing Morning chronotype, Intermediate chronotype and Evening chronotype in people with Chronotype and Pregnancy Complications, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women. Methods: Eighty-five pregnant women in the second trimester were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronotype, Pregnancy Complications
- What is being tested?
- Morning chronotype, Intermediate chronotype and Evening chronotype
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between the ages of 18-40,
- having a singleton pregnancy, being in the second trimester,
- not having any known chronic disease.
Who cannot join
- working night shifts,
- having a high-risk pregnancy,
- having a neurological or orthopedic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.
Methods: Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.
Read the detailed description
Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.
Methods: This study is a single-blind (participants), parallel trial. It was performed in line with the principles of the Declaration of Helsinki. The followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. Exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.
- Conditions
- Chronotype, Pregnancy Complications
- Being tested
- Morning chronotype, Intermediate chronotype, Evening chronotype
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning chronotypeOther
Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined.
Intermediate chronotypeOther
Sleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined.
Evening chronotypeOther
Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined.
| Study group | Role | What they receive |
|---|---|---|
| Morning Chronotype | Experimental | Sleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined. Receives: Other: Morning chronotype |
| Intermediate chronotype | Experimental | Sleep quality, gestational diabetes and pregnancy symptoms of Intermediate chronotype individuals were examined. Receives: Other: Intermediate chronotype |
| Evening chronotype | Experimental | Sleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined. Receives: Other: Evening chronotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Morningness-Eveningness Questionnaire (MEQ)
It was used to measure the preference for a certain chronotype. This validated questionnaire evaluates individual differences in the degree to which respondents are aware and active at different times of the day. It has 19 items on sleep patterns and exhaustion. The responses to the scale items indicate preferences for waking and sleeping hours as well as the subjective "peak" times when respondents feel most refreshed. People were categorized as morningness chronotype (>65), intermediate chronotype (53-64), or eveningness chronotype (score of <52). The reliability of MEQ was 0.77 and the test alpha was equal to 0.78 (20).
Measured: 5 minutes
The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)
The PUQE is a scoring system for nausea and vomiting during pregnancy, which consists of three items. The original PUQE entailed rating the daily number of vomiting episodes, the length of nausea in hours per day, and the number of retching episodes per 12 hours. Its validation was confirmed a total score of 3-6 is considered mild nausea and vomiting, a total score of 7-12 is considered moderate nausea and vomiting, and a total score of 13-15 is considered severe nausea and vomiting
Measured: 5 minutes
Oral Glucose Tolerance Testing (OGTT)
Pregnant women undergo a 75 g OGTT test between 24 and 28 weeks of . A plasma fasting blood glucose>126 mg/dL in a pregnant woman is considered overt diabetes (after confirmation) even if there is no prior history of diabetes. The OGTT test involves measurement of plasma glucose levels after an overnight fast (8 h), followed by oral consumption of 75 g glucose, and plasma glucose measurement at one and two hours. Gestational diabetes was defined as a fasting plasma glucose value>92 mg/dL or a one-hour plasma glucose value>180 mg/dL or a two-hour plasma glucose value>153 mg/dl.
Measured: 15 minutes
The Pittsburgh Sleep Quality Index
It is evaluation of the sleep quality. There are 24 questions in all, 18 of which are used to determine the score. Subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disruptions, usage of sleeping pills, and dysfunction throughout the day are its seven constituent parts. The PSQI score is determined by assigning a point value between 0 and 3. A cumulative score of more than five indicates that the quality of sleep was inadequate. The score goes from 0 to 21.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChronotypeStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-blind (participants), parallel trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- MERVE YILMAZ MENEK, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413784
- Sponsor's protocol ID
- 10840098-772.02-6181
- Status last verified
- Oct 2024
- First submitted
- 9 May 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no a plan to make individual participant data (IPD)
Publications
Cassidy EM, Bailey CP, Napolitano MA, Vyas AN. Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study. Prev Med Rep. 2022 Dec 6;31:102088. doi: 10.1016/j.pmedr.2022.102088. eCollection 2023 Feb.
PubMed 36820370
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining The Effect of Chronotype Differences on Sleep Quality and Pregnancy Symptoms in Pregnant Women
- ClinicalTrials.gov ID
- NCT06413784
- Acronym / sponsor ID
- 10840098-772.02-6181
- Conditions
- Chronotype, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 May 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.
Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.
Methods: Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.
Detailed description
Purpose: The aim of this study was to examine the effect of chronotype differences on sleep quality and pregnancy symptoms in pregnant women.
Methods: This study is a single-blind (participants), parallel trial. It was performed in line with the principles of the Declaration of Helsinki. The followings were the study's inclusion requirements: being between the ages of 18-40, having a singleton pregnancy, being in the second trimester, and not having any known chronic disease. Exclusion criteria are working night shifts, having a high-risk pregnancy, and having a neurological or orthopedic disease. Eighty-five pregnant women in the second trimester were included in the study. The chronotypes of pregnant women were determined using the Morningness-Eveningness Questionnaire (MEQ). Then, Oral Glucose Tolerance tests were performed on the participants between 24-28 weeks. Also, pregnant women's nausea and vomiting conditions with the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) and sleep quality with Pittsburgh Sleep Quality Index (PSQI) were evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study is a single-blind (participants), parallel trial
| Arm | Type | Receives |
|---|---|---|
| Morning Chronotype | Experimental | Other: Morning chronotypeSleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined. |
| Intermediate chronotype | Experimental | Other: Intermediate chronotypeSleep quality, gestational diabetes and pregnancy symptoms of Intermediate chronotype individuals were examined. |
| Evening chronotype | Experimental | Other: Evening chronotypeSleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being between the ages of 18-40,
- having a singleton pregnancy, being in the second trimester,
- not having any known chronic disease.
Key exclusion criteria (3 listed)
- working night shifts,
- having a high-risk pregnancy,
- having a neurological or orthopedic disease.
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 |
|---|---|---|
| Morning chronotypeSleep quality, gestational diabetes and pregnancy symptoms of morning chronotype individuals were examined. | Other | Morning Chronotype |
| Intermediate chronotypeSleep quality, gestational diabetes and pregnancy symptoms of intermediate chronotype individuals were examined. | Other | Intermediate chronotype |
| Evening chronotypeSleep quality, gestational diabetes and pregnancy symptoms of evening chronotype individuals were examined. | Other | Evening chronotype |
Primary outcome
The Morningness-Eveningness Questionnaire (MEQ)
Time frame: 5 minutes
It was used to measure the preference for a certain chronotype. This validated questionnaire evaluates individual differences in the degree to which respondents are aware and active at different times of the day. It has 19 items on sleep patterns and exhaustion. The responses to the scale items indicate preferences for waking and sleeping hours as well as the subjective "peak" times when respondents feel most refreshed. People were categorized as morningness chronotype (>65), intermediate chronotype (53-64), or eveningness chronotype (score of <52). The reliability of MEQ was 0.77 and the test alpha was equal to 0.78 (20).
The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)
Time frame: 5 minutes
The PUQE is a scoring system for nausea and vomiting during pregnancy, which consists of three items. The original PUQE entailed rating the daily number of vomiting episodes, the length of nausea in hours per day, and the number of retching episodes per 12 hours. Its validation was confirmed a total score of 3-6 is considered mild nausea and vomiting, a total score of 7-12 is considered moderate nausea and vomiting, and a total score of 13-15 is considered severe nausea and vomiting
Oral Glucose Tolerance Testing (OGTT)
Time frame: 15 minutes
Pregnant women undergo a 75 g OGTT test between 24 and 28 weeks of . A plasma fasting blood glucose>126 mg/dL in a pregnant woman is considered overt diabetes (after confirmation) even if there is no prior history of diabetes. The OGTT test involves measurement of plasma glucose levels after an overnight fast (8 h), followed by oral consumption of 75 g glucose, and plasma glucose measurement at one and two hours. Gestational diabetes was defined as a fasting plasma glucose value>92 mg/dL or a one-hour plasma glucose value>180 mg/dL or a two-hour plasma glucose value>153 mg/dl.
The Pittsburgh Sleep Quality Index
Time frame: 10 minutes
It is evaluation of the sleep quality. There are 24 questions in all, 18 of which are used to determine the score. Subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disruptions, usage of sleeping pills, and dysfunction throughout the day are its seven constituent parts. The PSQI score is determined by assigning a point value between 0 and 3. A cumulative score of more than five indicates that the quality of sleep was inadequate. The score goes from 0 to 21.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Results publication: PubMed 36820370Cassidy EM, Bailey CP, Napolitano MA, Vyas AN. Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study. Prev Med Rep. 2022 Dec 6;31:102088. doi: 10.1016/j.pmedr.2022.102088. eCollection 2023 Feb.
- Sleep duration and chronotype of pregnant women in the United States: An online cross-sectional survey study.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no a plan to make individual participant data (IPD)
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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. This study is not recruiting at the moment.
MERVE YILMAZ MENEK, PhD principal investigator
Medipol 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 Morning chronotype, Intermediate chronotype and Evening chronotype in people with Chronotype and Pregnancy Complications, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Oct 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Morningness-Eveningness Questionnaire (MEQ) (time frame: 5 minutes). 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?
On the ClinicalTrials.gov record for NCT06413784, which also lists 1 linked publication.
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 3 Oct 2024.