Pregnancy With Insomnia: a Trial of Acupuncture

Insomnia Clinical Trial

— GAS  

Official title:

Pregnancy With Insomnia: a Trial of Acupuncture

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03194191
• Other study ID #: P150951
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2017
• Last updated: June 27, 2017
• Start date: September 2017
• Est. completion date: May 2019

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Stéphanie Nicolian, Midewife
• Phone: 0033 6 25 71 08 64
• Email: snicolian[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Perinatal outcome - Gestational age at birth	The gestational age at birth of the newborn will be recorded.	At birth
Secondary	Perinatal outcome - birth weight	The weight (in gr) at birth of the newborn will be recorded.	At birth
Secondary	Perinatal outcome - birth height	The height (in cm) at birth of the newborn will be recorded.	At birth
Secondary	Perinatal outcome - sex	The sex of the newborn will be recorded.	At birth
Secondary	Perinatal outcome - perinatal mortality	The perinatal mortality will be recorded.	At birth
Secondary	Perinatal outcome - five minutes Apgar score	The five minutes Apgar score will be recorded.	At birth
Secondary	Perinatal outcome - cesarean section rate	Cesarean section rate will be recorded.	At birth.