Sleep Initiation and Maintenance DisordersNCT03763071
Sleep Disturbances in the 2nd and 3rd Trimester
An observational study of Sleep Initiation and Maintenance Disorders and Sleep, run by Bartin State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover, this problem is generally neglected by the pregnant themselves. Today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Sleep, Sleep Apnea
- What is being tested?
- Patient-reported scales to measure sleep disorders
- How many people
- 683 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2018to 29 Apr 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteered, low-risk, uncomplicated singleton pregnancy
Who may be able to join
- 2nd or 3rd trimester of pregnancy
Who cannot join
- Complicated pregnancy
- Multiple pregnancy
- Known sleep disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy
Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover, this problem is generally neglected by the pregnant themselves. Today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy.
This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.
Read the detailed description
Women with uncomplicated pregnancy in the second or third trimester who apply for the routine check will be included.
Specific questionnaires will be used to measure the sleep disorders in addition to the socio-demographic measures:
Pittsburgh Sleep Quality Index, Insomnia Severity Index, Berlin Questionnaire and Stop-Bang Questionnaire.
- Conditions
- Sleep Initiation and Maintenance Disorders, Sleep, Sleep Apnea, Sleep Disorder, Sleep Disturbance, Sleep Apnea, Obstructive
- Being tested
- Patient-reported scales to measure sleep disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Apnea Syndromes, Sleep Wake Disorders, Parasomnias, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-reported scales to measure sleep disordersOther
Patient-reported scales to measure sleep disorders include below mentioned scales:
Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters
| Study group | Role | What they receive |
|---|---|---|
| Participants | Pregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders Receives: Other: Patient-reported scales to measure sleep disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Through study completion, an average of 39 weeks
Berlin Questionnaire
The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Measured: Through study completion, an average of 39 weeks
Stop-Bang questionnaire
This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.
Measured: Through study completion, an average of 39 weeks
Insomnia Severity Index (ISI)
ISI measures the insomnia and related parameters. Scoring and Interpretation as follows: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) will give the total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: Through study completion, an average of 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start7 Dec 2018
- Primary completion8 Apr 2020
- Study completion29 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartin State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Yassa, Bartin State Hospital
- Investigators
- Murat Yassa, MD, Principal investigator, Bartin State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763071
- Sponsor's protocol ID
- 2018-1
- Status last verified
- Jan 2021
- First submitted
- 23 Nov 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy
- ClinicalTrials.gov ID
- NCT03763071
- Acronym / sponsor ID
- 2018-1
- Conditions
- Sleep Initiation and Maintenance Disorders, Sleep, Sleep Apnea, Sleep Disorder, Sleep Disturbance, Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Bartin State HospitalOther government
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (actual)
- First posted
- 4 Dec 2018 (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.
Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover, this problem is generally neglected by the pregnant themselves. Today, it is important to underline any problem that may have an affect to improve the quality of life during pregnancy.
This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.
Detailed description
Women with uncomplicated pregnancy in the second or third trimester who apply for the routine check will be included.
Specific questionnaires will be used to measure the sleep disorders in addition to the socio-demographic measures:
Pittsburgh Sleep Quality Index, Insomnia Severity Index, Berlin Questionnaire and Stop-Bang Questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: Patient-reported scales to measure sleep disordersPregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteered, low-risk, uncomplicated singleton pregnancy
Key inclusion criteria (1 listed)
- 2nd or 3rd trimester of pregnancy
Key exclusion criteria (3 listed)
- Complicated pregnancy
- Multiple pregnancy
- Known 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 |
|---|---|---|
| Patient-reported scales to measure sleep disordersPatient-reported scales to measure sleep disorders include below mentioned scales: Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters | Other | Participants |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Through study completion, an average of 39 weeks
The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Berlin Questionnaire
Time frame: Through study completion, an average of 39 weeks
The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Stop-Bang questionnaire
Time frame: Through study completion, an average of 39 weeks
This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.
Insomnia Severity Index (ISI)
Time frame: Through study completion, an average of 39 weeks
ISI measures the insomnia and related parameters. Scoring and Interpretation as follows: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) will give the total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
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 26 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Murat Yassa, MD principal investigator
Bartin State Hospital
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 Initiation and Maintenance Disorders and Sleep, run by Bartin State 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 1 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 26 Jan 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?
Pittsburgh Sleep Quality Index (PSQI) (time frame: Through study completion, an average of 39 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 26 Jan 2021.