Pregnancy With Insomnia: a Trial of Acupuncture (GAS)
Acupuncture is widely used for treatment of insomnia. The research hypothesis is that acupuncture may be more effective than sham acupuncture to treat insomnia during pregnancy.
GAS is a randomized controlled trial with placebo acupuncture using the insomnia severity index (ISI) as the main outcome criterion.
研究概览
详细说明
Scientific justification:
- During pregnancy, insomnia occurs mainly in women without a previous history of sleep disorder, and may remain after delivery. Insomnia affects the quality of life. It might be associated with an increase in labor duration and cesarean section rate.
Insomnia tends to worsen during gestation, owing to back pain, an increased need to micturate, and the movement of the fetus. Sleep disorders are often associated with restless legs syndrome.
- To treat insomnia during pregnancy, the Haute Autorité de Santé (HAS) recommends avoiding using psychotropic medications. It also recommends screening for depression or anxiety traits often associated with insomnia. However, in most cases, psychological means alone fail to treat insomnia effectively.
- Based on 11 randomized controlled trials, the odds of improving sleep disorders are 3 times greater with than without acupuncture, but the methodological quality of these trials is considered insufficient to conclude.
Population:
The study focused on pregnant women suffering from insomnia, excluding women with pregnancies complicated by pre-eclampsia, fetal growth anomalies, or threatened premature labor for fear those complications might interact with sleep disorders, as well as women with known psychiatric disorders. We also excluded women with a history of insomnia before pregnancy to focus on insomnia triggered by pregnancy only.
Objectives:
- Primary objective: To assess the effect of a standardized acupuncture protocol vs. placebo on insomnia during pregnancy.
- Secondary objectives: To assess the effect of a standardized acupuncture protocol vs. placebo on (i) the Pittsburgh Sleep Quality Index (PSQI), (ii) anxiety and depression traits, (iii) use of psychotropic medicines and (iv) recreational substances, (v) the incidence of restless legs syndrome, (vi) perinatal outcome .
Study design:
- Study Type: Multicentre, Interventional, randomized, 2 parallel groups
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Single blind (patient blinded to intervention)
- Primary Purpose: Treatment
- One acupuncture session weekly for 4 consecutive weeks
Visits:
- Selection: When a pregnant woman complains from insomnia, the health professional in charge will fill a checklist of inclusion and exclusion criteria, provide the patient with a pre inclusion ISI questionnaire and give the patient an information sheet and a copy of the consent. When a pregnant woman is sent to the acupuncturist for sleep disorders, he or she may proceed to the selection visit.
- Inclusion: The acupuncturist checks for inclusion and exclusion criteria, collects the patient written consent, performs the clinical examination, gives the corresponding self-assessment questionnaires and proceeds to computerized randomization.
- Follow-up: At visits 1 to 4, the acupuncturist performs the treatment, and records side effects if any. Visits are scheduled on a weekly basis.
- End of research: At visit 5 (one week after last acupuncture session), the acupuncturist gives the corresponding self-assessment questionnaires.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > 18 years
- Singleton pregnancy
- Gestational age ≥ 16 weeks + 0 day and ≤ 32 weeks + 6 days
- Insomnia Severity Index ≥ 10
- Insomnia reported to have started during pregnancy and at least 2 weeks before inclusion
- Patient understanding the study
- Informed consent signed
- Social insurance available at inclusion and until the end of pregnancy
Exclusion Criteria:
- Threatened premature labor
- Small fetus for gestational age
- Pre-eclampsia
- Insomnia starting before pregnancy
- Use of psychotropic drugs before pregnancy
- Use of recreational drugs during pregnancy
- Known psychiatric disorder
- Anticoagulant therapy
- Patient reporting insomnia results from chronic or acute pain
- Obstructive sleep apnea (OSA) requiring treatment
- Patient under antidepressant therapy
- Patient under legal guardianship or deprived of freedom
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Regular acupuncture needles
Real acupuncture procedure The real acupuncture will be performed by means of standard stainless-steel needles (0.30-mm diameter, 30-mm length/Gauge 8 x 1.2"), located bilaterally in 5 real acupoints.
|
The patient will be in a semi recumbent position during needle penetration.
Duration of needle insertion: 30 minutes
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假比较器:Sham acupuncture needles
Sham acupuncture with a no penetrating sham needle (blunt and telescopic), giving the impression of insertion but without penetrating the skin will be placed bilaterally in 5 false acupoints
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The patient will be in a semi recumbent position during needle penetration.
Duration of needle insertion: 30 minutes
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Insomnia severity index (ISI)
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
|
Difference of ISI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
|
Inclusion visit and 5 weeks after the first acupuncture session
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
|
Difference of PSQI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
|
Inclusion visit and 5 weeks after the first acupuncture session
|
Hospital Anxiety and Depression Scale (HADS)
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
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Difference of HADS self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of each psychotropic medicine
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
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During the study period, the patients will note on a logbook the daily use of any drug.
|
Inclusion visit and 5 weeks after the first acupuncture session
|
Cumulated dose of alcohol
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
|
During the study period, the patients will note on a logbook the daily use of alcohol.
|
Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of tobacco
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
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During the study period, the patients will note on a logbook the daily use of tobacco.
|
Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of cannabis
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
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During the study period, the patients will note on a logbook the daily use of cannabis.
|
Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of other recreational substances or medicine
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
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During the study period, the patients will note on a logbook the daily use of other recreational substances and medicine.
|
Inclusion visit and 5 weeks after the first acupuncture session
|
Difference in the frequency of restless leg syndrome
大体时间:Inclusion visit and 5 weeks after the first acupuncture session
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According to the guidelines of the International Restless Legs Syndrome Study Group. The diagnosis of restless leg will rely on the presence of all of the following criteria:
|
Inclusion visit and 5 weeks after the first acupuncture session
|
Perinatal outcome - Gestational age at birth
大体时间:At birth
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The gestational age at birth of the newborn will be recorded.
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At birth
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Perinatal outcome - birth weight
大体时间:At birth
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The weight (in gr) at birth of the newborn will be recorded.
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At birth
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Perinatal outcome - birth height
大体时间:At birth
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The height (in cm) at birth of the newborn will be recorded.
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At birth
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Perinatal outcome - sex
大体时间:At birth
|
The sex of the newborn will be recorded.
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At birth
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Perinatal outcome - perinatal mortality
大体时间:At birth
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The perinatal mortality will be recorded.
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At birth
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Perinatal outcome - five minutes Apgar score
大体时间:At birth
|
The five minutes Apgar score will be recorded.
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At birth
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Perinatal outcome - cesarean section rate
大体时间:At birth.
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Cesarean section rate will be recorded.
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At birth.
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合作者和调查者
调查人员
- 首席研究员:Stéphanie Nicolian, Midewife、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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