InsomniaGASNCT03194191
Pregnancy With Insomnia: a Trial of Acupuncture
A study testing Acupuncture needles in people with Insomnia, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Acupuncture needles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Acupuncture needles
- Keywords
- Insomnia, Pregnancy, Acupuncture, Insomnia severity index, Pittsburgh Sleep Quality Index, Anxiety, Depression
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture needlesDevice
The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Regular acupuncture needles | Experimental | 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. Receives: Device: Acupuncture needles |
| Sham acupuncture needles | Sham comparator | 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 Receives: Device: Acupuncture needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity index (ISI)
Difference of ISI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
Measured: Inclusion visit and 5 weeks after the first acupuncture session
Secondary outcomes (15)
Pittsburgh Sleep Quality Index (PSQI)
Difference of PSQI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At birth
Perinatal outcome - birth weight
The weight (in gr) at birth of the newborn will be recorded.
Measured: At birth
Perinatal outcome - birth height
The height (in cm) at birth of the newborn will be recorded.
Measured: At birth
Perinatal outcome - sex
The sex of the newborn will be recorded.
Measured: At birth
Perinatal outcome - perinatal mortality
The perinatal mortality will be recorded.
Measured: At birth
Perinatal outcome - five minutes Apgar score
The five minutes Apgar score will be recorded.
Measured: At birth
Perinatal outcome - cesarean section rate
Cesarean section rate will be recorded.
Measured: At birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startSep 2017 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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,
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Nicolian, Midewife, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194191
- Sponsor's protocol ID
- P150951
- Acronym
- GAS
- Status last verified
- Apr 2017
- First submitted
- 23 May 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy With Insomnia: a Trial of Acupuncture
- ClinicalTrials.gov ID
- NCT03194191
- Acronym / sponsor ID
- GAS / P150951
- Conditions
- Insomnia
- Keywords
- Insomnia, Pregnancy, Acupuncture, Insomnia severity index, Pittsburgh Sleep Quality Index, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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,
| Arm | Type | Receives |
|---|---|---|
| Regular acupuncture needles | Experimental | Device: Acupuncture needlesReal 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. |
| Sham acupuncture needles | Sham comparator | Device: Acupuncture needlesSham 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- Threatened premature labor
- Small fetus for gestational age
- Pre-eclampsia
- Insomnia starting before pregnancy
- Use of psychotropic drugs before pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture needlesThe patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes | Device | Regular acupuncture needles, Sham acupuncture needles |
Primary outcome
Insomnia severity index (ISI)
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Difference of ISI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
15 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Hospital Anxiety and Depression Scale (HADS)
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Cumulated dose of each psychotropic medicine
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Cumulated dose of alcohol
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Cumulated dose of tobacco
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Cumulated dose of cannabis
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Cumulated dose of other recreational substances or medicine
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Difference in the frequency of restless leg syndrome
Time frame: Inclusion visit and 5 weeks after the first acupuncture session
Perinatal outcome - Gestational age at birth
Time frame: At birth
Perinatal outcome - birth weight
Time frame: At birth
Perinatal outcome - birth height
Time frame: At birth
Perinatal outcome - sex
Time frame: At birth
Perinatal outcome - perinatal mortality
Time frame: At birth
Perinatal outcome - five minutes Apgar score
Time frame: At birth
Perinatal outcome - cesarean section rate
Time frame: At birth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Nicolian, Midewife principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture needles in people with Insomnia, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Nicolian, Midewife (0033 6 25 71 08 64, snicolian@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (ISI) (time frame: Inclusion visit and 5 weeks after the first acupuncture session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.