Pregnancy With Insomnia: a Trial of Acupuncture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pregnancy With Insomnia: a Trial of Acupuncture

Conditions
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Insomnia

Intervention / Treatment
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* Device: Acupuncture needles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with regular acupuncture needles vs. sham needles. In addition, the sham needles will be placed in areas that do not correspond to any known acupuncture point. 5 bilateral acupoints or placebo acupoints,
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular acupuncture needles<br>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. | Device: Acupuncture needles<br>* The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes<br>|
| Sham Comparator: Sham acupuncture needles<br>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 | Device: Acupuncture needles<br>* The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity index (ISI) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI) | 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) | Difference of HADS 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 | 
| Cumulated dose of each psychotropic medicine | 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 | 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 | 
| Cumulated dose of tobacco | 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 | 
| Cumulated dose of cannabis | 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 | 
| Cumulated dose of other recreational substances or medicine | 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 | 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: Desire to move the extremities usually associated with discomfort or disagreeable sensations in the extremities. Motor Restlessness-patients move to relieve the discomfort, for example walking, or to provide a counter-stimulus to relieve the discomfort, for example, rubbing the legs. Symptoms are worse at rest with at least temporary relief by activity. Symptoms are worse later in the day or at night. | Inclusion visit and 5 weeks after the first acupuncture session | 
| Perinatal outcome - Gestational age at birth | The gestational age at birth of the newborn will be recorded. | At birth | 
| Perinatal outcome - birth weight | The weight (in gr) at birth of the newborn will be recorded. | At birth | 
| Perinatal outcome - birth height | The height (in cm) at birth of the newborn will be recorded. | At birth | 
| Perinatal outcome - sex | The sex of the newborn will be recorded. | At birth | 
| Perinatal outcome - perinatal mortality | The perinatal mortality will be recorded. | At birth | 
| Perinatal outcome - five minutes Apgar score | The five minutes Apgar score will be recorded. | At birth | 
| Perinatal outcome - cesarean section rate | Cesarean section rate will be recorded. | At birth. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Pregnancy, Acupuncture, Insomnia severity index, Pittsburgh Sleep Quality Index, Anxiety, Depression