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临床试验/NCT03763071
NCT03763071已完成不适用

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

Bartin State Hospital1 个研究点 分布在 1 个国家目标入组 683 人开始时间: 2018年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
683
试验地点
1
主要终点
Pittsburgh Sleep Quality Index (PSQI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 2nd or 3rd trimester of pregnancy

排除标准

  • Complicated pregnancy
  • Multiple pregnancy
  • Known sleep disorder

结局指标

主要结局

Pittsburgh Sleep Quality Index (PSQI)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
Bartin State Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Murat Yassa

M.D.

Bartin State Hospital

研究点 (1)

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