Sleep Disturbances in the 2nd and 3rd Trimester

Completed

• Conditions: Pregnancy Related; Pregnancy; Sleep; Sleep Apnea; Sleep Disorder; Sleep Initiation and Maintenance Disorders; Sleep Disturbance; Sleep Apnea, Obstructive
• Interventions: Other: Patient-reported scales to measure sleep disorders

• Registration Number: NCT03763071
• Lead Sponsor: Bartin State Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-12-01
• Study First Posted: 2018-12-04
• Study Start: 2018-12-07
• Primary Completion: 2020-04-08
• Study Completion: 2020-04-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 683

Inclusion Criteria

• 2nd or 3rd trimester of pregnancy

Exclusion Criteria

• Complicated pregnancy
• Multiple pregnancy
• Known sleep disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Patient-reported scales to measure sleep disorders	Pregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	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	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	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)	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)

Trial Locations

Locations (1)

Bartin State Hospital; 🇹🇷 Bartin, Turkey