Pregnancy With Insomnia: a Trial of Acupuncture (GAS)
27 juin 2017 mis à jour par: Assistance Publique - Hôpitaux de Paris
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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
The patient will be in a semi recumbent position during needle penetration.
Duration of needle insertion: 30 minutes
|
|
Comparateur factice: 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
|
The patient will be in a semi recumbent position during needle penetration.
Duration of needle insertion: 30 minutes
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insomnia severity index (ISI)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Délai: 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)
Délai: 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
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|
Cumulated dose of each psychotropic medicine
Délai: 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
Délai: 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
|
|
Cumulated dose of tobacco
Délai: 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.
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of cannabis
Délai: 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.
|
Inclusion visit and 5 weeks after the first acupuncture session
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|
Cumulated dose of other recreational substances or medicine
Délai: 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 other recreational substances and medicine.
|
Inclusion visit and 5 weeks after the first acupuncture session
|
|
Difference in the frequency of restless leg syndrome
Délai: 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
Délai: At birth
|
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
Délai: At birth
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The weight (in gr) at birth of the newborn will be recorded.
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At birth
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Perinatal outcome - birth height
Délai: 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
Délai: At birth
|
The sex of the newborn will be recorded.
|
At birth
|
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Perinatal outcome - perinatal mortality
Délai: At birth
|
The perinatal mortality will be recorded.
|
At birth
|
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Perinatal outcome - five minutes Apgar score
Délai: At birth
|
The five minutes Apgar score will be recorded.
|
At birth
|
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Perinatal outcome - cesarean section rate
Délai: At birth.
|
Cesarean section rate will be recorded.
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At birth.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Stéphanie Nicolian, Midewife, Assistance Publique - Hopitaux de Paris
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 septembre 2017
Achèvement primaire (Anticipé)
1 janvier 2019
Achèvement de l'étude (Anticipé)
1 mai 2019
Dates d'inscription aux études
Première soumission
23 mai 2017
Première soumission répondant aux critères de contrôle qualité
19 juin 2017
Première publication (Réel)
21 juin 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 juin 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 juin 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P150951
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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