Pregnancy With Insomnia: a Trial of Acupuncture

NCT ID: NCT03194191

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2019-05-31

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture needles

Intervention Type: DEVICE

The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes

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

Group Type: SHAM_COMPARATOR

Acupuncture needles

Intervention Type: DEVICE

The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes

Interventions

Acupuncture needles

The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie Nicolian, Midewife

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Central Contacts

Stéphanie Nicolian, Midewife

Role: CONTACT

snicolian@yahoo.fr

0033 6 25 71 08 64

Marc Dommergues, PUPH

Role: CONTACT

marc.dommergues@aphp.fr

0033 6 08 48 69 25

Other Identifiers

P150951

Identifier Type: -

Identifier Source: org_study_id