Pregnancy With Insomnia: a Trial of Acupuncture (GAS)

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Device: Acupuncture needles

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Acupuncture needles; The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes
Sham Comparator: 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	Device: Acupuncture needles; The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Stéphanie Nicolian, Midewife, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Acupuncture; Pregnancy; Insomnia; Insomnia severity index; Pittsburgh Sleep Quality Index
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: P150951

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No