- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03194191
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
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The patient will be in a semi recumbent position during needle penetration.
Duration of needle insertion: 30 minutes
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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
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The patient will be in a semi recumbent position during needle penetration.
Duration of needle insertion: 30 minutes
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Insomnia severity index (ISI)
Tidsram: 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
|
Inclusion visit and 5 weeks after the first acupuncture session
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
|
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)
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
|
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
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
|
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
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
|
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
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Cumulated dose of tobacco
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
|
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
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Cumulated dose of cannabis
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
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During the study period, the patients will note on a logbook the daily use of cannabis.
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of other recreational substances or medicine
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
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During the study period, the patients will note on a logbook the daily use of other recreational substances and medicine.
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Inclusion visit and 5 weeks after the first acupuncture session
|
Difference in the frequency of restless leg syndrome
Tidsram: Inclusion visit and 5 weeks after the first acupuncture session
|
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:
|
Inclusion visit and 5 weeks after the first acupuncture session
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Perinatal outcome - Gestational age at birth
Tidsram: At birth
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The gestational age at birth of the newborn will be recorded.
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At birth
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Perinatal outcome - birth weight
Tidsram: At birth
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The weight (in gr) at birth of the newborn will be recorded.
|
At birth
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Perinatal outcome - birth height
Tidsram: At birth
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The height (in cm) at birth of the newborn will be recorded.
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At birth
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Perinatal outcome - sex
Tidsram: At birth
|
The sex of the newborn will be recorded.
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At birth
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Perinatal outcome - perinatal mortality
Tidsram: At birth
|
The perinatal mortality will be recorded.
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At birth
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Perinatal outcome - five minutes Apgar score
Tidsram: At birth
|
The five minutes Apgar score will be recorded.
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At birth
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Perinatal outcome - cesarean section rate
Tidsram: At birth.
|
Cesarean section rate will be recorded.
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At birth.
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Stéphanie Nicolian, Midewife, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P150951
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