Pregnancy With Insomnia: a Trial of Acupuncture — GAS  

Insomnia Clinical Trial

Official title: Pregnancy With Insomnia: a Trial of Acupuncture

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT03194191
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Stéphanie Nicolian, Midewife
• Phone: 0033 6 25 71 08 64
• Email: snicolian@yahoo.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2017
• Completion date: May 2019