- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Insomnia severity index (ISI)
Lasso di tempo: Inclusion visit and 5 weeks after the first acupuncture session
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Difference of ISI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
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Inclusion visit and 5 weeks after the first acupuncture session
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Lasso di tempo: Inclusion visit and 5 weeks after the first acupuncture session
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Difference of PSQI self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
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Inclusion visit and 5 weeks after the first acupuncture session
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Hospital Anxiety and Depression Scale (HADS)
Lasso di tempo: Inclusion visit and 5 weeks after the first acupuncture session
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Difference of HADS self-report questionnaire administrated at inclusion visit and 5 weeks after the first acupuncture session
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of each psychotropic medicine
Lasso di tempo: 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 any drug.
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of alcohol
Lasso di tempo: 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 alcohol.
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of tobacco
Lasso di tempo: 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 tobacco.
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Inclusion visit and 5 weeks after the first acupuncture session
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Cumulated dose of cannabis
Lasso di tempo: 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
Lasso di tempo: 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
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Difference in the frequency of restless leg syndrome
Lasso di tempo: Inclusion visit and 5 weeks after the first acupuncture session
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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:
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Inclusion visit and 5 weeks after the first acupuncture session
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Perinatal outcome - Gestational age at birth
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At birth
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The sex of the newborn will be recorded.
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At birth
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Perinatal outcome - perinatal mortality
Lasso di tempo: At birth
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The perinatal mortality will be recorded.
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At birth
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Perinatal outcome - five minutes Apgar score
Lasso di tempo: At birth
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The five minutes Apgar score will be recorded.
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At birth
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Perinatal outcome - cesarean section rate
Lasso di tempo: At birth.
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Cesarean section rate will be recorded.
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At birth.
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Stéphanie Nicolian, Midewife, Assistance Publique - Hôpitaux de Paris
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P150951
Piano per i dati dei singoli partecipanti (IPD)
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