Clinical trial NCT03194191: Pregnancy With Insomnia: a Trial of Acupuncture
Official title: Pregnancy With Insomnia: a Trial of Acupuncture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Pregnancy
Acupuncture
Insomnia severity index
Pittsburgh Sleep Quality Index
Anxiety
Depression
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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,
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia severity index (ISI)
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Cumulated dose of each psychotropic medicine
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Cumulated dose of alcohol
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Cumulated dose of tobacco
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Cumulated dose of cannabis
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Cumulated dose of other recreational substances or medicine
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Difference in the frequency of restless leg syndrome
timeFrame: Inclusion visit and 5 weeks after the first acupuncture session
measure: Perinatal outcome - Gestational age at birth
timeFrame: At birth
measure: Perinatal outcome - birth weight
timeFrame: At birth
measure: Perinatal outcome - birth height
timeFrame: At birth
measure: Perinatal outcome - sex
timeFrame: At birth
measure: Perinatal outcome - perinatal mortality
timeFrame: At birth
measure: Perinatal outcome - five minutes Apgar score
timeFrame: At birth
measure: Perinatal outcome - cesarean section rate
timeFrame: At birth.
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stéphanie Nicolian, Midewife
role: PRINCIPAL_INVESTIGATOR
References: