Sleep Disturbances in the 2nd and 3rd Trimester

Pregnancy Clinical Trial

Official title:

Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763071
• Other study ID #: 2018-1
• Status: Completed
• Start date: December 7, 2018
• Est. completion date: April 29, 2020

Study information

• Verified date: January 2021
• Source: Bartin State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the second and third trimesters of pregnancy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: April 29, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 2nd or 3rd trimester of pregnancy

Exclusion Criteria:

• Complicated pregnancy

• Multiple pregnancy

• Known sleep disorder

Related Conditions & MeSH terms

• Apnea
• Disease
• Dyssomnias
• Parasomnias
• Pregnancy
• Pregnancy Related
• Sleep
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Other:
• Patient-reported scales to measure sleep disorders
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

Locations

Country	Name	City	State
Turkey	Bartin State Hospital	Bartin

Sponsors (1)

Lead Sponsor	Collaborator
Bartin State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 39 weeks
Primary	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.	Through study completion, an average of 39 weeks
Primary	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.	Through study completion, an average of 39 weeks
Primary	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)	Through study completion, an average of 39 weeks