Pregnancy With Insomnia: a Trial of Acupuncture
- Conditions
- Insomnia
- Interventions
- Device: Acupuncture needles
- Registration Number
- NCT03194191
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham acupuncture needles 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 Regular acupuncture needles 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.
- Primary Outcome Measures
Name Time Method Insomnia severity index (ISI) 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
- Secondary Outcome Measures
Name Time Method Perinatal outcome - sex At birth The sex of the newborn will be recorded.
Pittsburgh Sleep Quality Index (PSQI) 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
Cumulated dose of tobacco 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 tobacco.
Perinatal outcome - Gestational age at birth At birth The gestational age at birth of the newborn will be recorded.
Perinatal outcome - birth weight At birth The weight (in gr) at birth of the newborn will be recorded.
Perinatal outcome - perinatal mortality At birth The perinatal mortality will be recorded.
Perinatal outcome - five minutes Apgar score At birth The five minutes Apgar score will be recorded.
Hospital Anxiety and Depression Scale (HADS) Inclusion visit and 5 weeks after the first acupuncture session Difference of HADS self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
Perinatal outcome - birth height At birth The height (in cm) at birth of the newborn will be recorded.
Perinatal outcome - cesarean section rate At birth. Cesarean section rate will be recorded.
Cumulated dose of each psychotropic medicine 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 any drug.
Cumulated dose of alcohol 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.
Cumulated dose of cannabis 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 cannabis.
Difference in the frequency of restless leg syndrome Inclusion visit and 5 weeks after the first acupuncture session 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:
1. Desire to move the extremities usually associated with discomfort or disagreeable sensations in the extremities.
2. 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.
3. Symptoms are worse at rest with at least temporary relief by activity.
4. Symptoms are worse later in the day or at night.Cumulated dose of other recreational substances or medicine 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 other recreational substances and medicine.