Sleep DisorderNCT04918368
Vitamin D and Sleep Disorders in Pregnancy
An observational study of Sleep Disorder and Pregnancy Related, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Sleep Disorder, Pregnancy Related, Vitamin D Deficiency
- What is being tested?
- Behavioral scales were used
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2017to 15 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 225 pregnant women who are in second or third trimester of pregnancy
Who may be able to join
- singletone pregnant women
- second and third trimester pregnant women
Who cannot join
- psychiatric disorder
- sleep disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?
Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.
- Conditions
- Sleep Disorder, Pregnancy Related, Vitamin D Deficiency
- Being tested
- Behavioral scales were used
- Keywords
- anxiety, Pregnancy,, Sleep Wake Disorders, Vitamin D
- Medical subject headings
- Sleep Wake Disorders, Vitamin D Deficiency, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral scales were usedBehavioural
Women's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women between 18-45 years old, being in second and third trimester of a singleton pregnancy | Not described Receives: Behavioral: Behavioral scales were used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Initiative Sleeplessness Scale (WHISS)
Women's Health Initiative Sleeplessness Scale (WHISS) was used to assess the sleep status of pregnant women. In this scale consisting of five questions, first four questions focus on the period of time when sleeplessness started, status of not being able to continue the sleep and waking up early in the morning, while the last one focusses to determine the sleep quality. Scores of the scale range between 0 - 20. A score equal and above 10 means a sleeplessness problem. An increase in score means intensifying the sleeplessness symptoms.
Measured: Through study completion, an average of 1 year
State Anxiety Scale (SAS)
In anxiety screening of pregnant women, State Anxiety Scale (SAS) was used. Scores of the scale including twenty questions range between min. 20 and max. 80. Higher scores mean higher anxiety.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start20 Aug 2017
- Primary completion25 Dec 2018
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 225 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918368
- Sponsor's protocol ID
- GaziosmanpasaTREHc
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Low Vitramin D Levels Increase the Frequency of Sleep Disorders and Anxiety in the 2nd and 3rd Trimester?
- ClinicalTrials.gov ID
- NCT04918368
- Acronym / sponsor ID
- GaziosmanpasaTREHc
- Conditions
- Sleep Disorder, Pregnancy Related, Vitamin D Deficiency
- Keywords
- anxiety, Pregnancy,, Sleep Wake Disorders, Vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 25 Dec 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 8 Jun 2021 (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.
Lack of sleep and poor sleep quality in pregnant women are associated with maternal depression and cognitive-sensual irregularities. These irregularities were reported worsening women's life quality and even increasing suicide ideation. It is also associated with obstetrical complications such as fetal growth deficiency, preterm birth, prolonged labor, preeclampsia and increased abdominal delivery frequency.Vitamin D also may affect the sleep indirectly through the cases with nonspecific pains. It was reported that vitamin D levels are correlated with sleep disorders such as obstructive sleep apnea and restless legs syndrome. The primary purpose of this study is to examine sleep disorders and vitamin D levels in pregnant women, and also, secondarily, vitamin D - anxiety and sleep disorders - anxiety relations were assessed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women between 18-45 years old, being in second and third trimester of a singleton pregnancy | – | Behavioral: Behavioral scales were used |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 225 pregnant women who are in second or third trimester of pregnancy
Key inclusion criteria (2 listed)
- singletone pregnant women
- second and third trimester pregnant women
Key exclusion criteria (2 listed)
- psychiatric disorder
- sleep disorder
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 |
|---|---|---|
| Behavioral scales were usedWomen's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied. | Behavioural | Pregnant women between 18-45 years old, being in second and third trimester of a singleton pregnancy |
Primary outcome
Health Initiative Sleeplessness Scale (WHISS)
Time frame: Through study completion, an average of 1 year
Women's Health Initiative Sleeplessness Scale (WHISS) was used to assess the sleep status of pregnant women. In this scale consisting of five questions, first four questions focus on the period of time when sleeplessness started, status of not being able to continue the sleep and waking up early in the morning, while the last one focusses to determine the sleep quality. Scores of the scale range between 0 - 20. A score equal and above 10 means a sleeplessness problem. An increase in score means intensifying the sleeplessness symptoms.
State Anxiety Scale (SAS)
Time frame: Through study completion, an average of 1 year
In anxiety screening of pregnant women, State Anxiety Scale (SAS) was used. Scores of the scale including twenty questions range between min. 20 and max. 80. Higher scores mean higher anxiety.
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 25 Aug 2021.
- 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. This study is not recruiting at the moment.
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?
An observational study of Sleep Disorder and Pregnancy Related, run by Gaziosmanpasa Research and Education 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 2 inclusion and 2 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 25 Aug 2021. 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?
Health Initiative Sleeplessness Scale (WHISS) (time frame: Through study completion, an average of 1 year). The study lists 2 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 25 Aug 2021.