Pregnancy With Insomnia: a Trial of Acupuncture (GAS)
27. Juni 2017 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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
|
|
Schein-Komparator: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Insomnia severity index (ISI)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
|
Cumulated dose of cannabis
Zeitfenster: 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 cannabis.
|
Inclusion visit and 5 weeks after the first acupuncture session
|
|
Cumulated dose of other recreational substances or medicine
Zeitfenster: 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
Zeitfenster: 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
|
|
Perinatal outcome - Gestational age at birth
Zeitfenster: At birth
|
The gestational age at birth of the newborn will be recorded.
|
At birth
|
|
Perinatal outcome - birth weight
Zeitfenster: At birth
|
The weight (in gr) at birth of the newborn will be recorded.
|
At birth
|
|
Perinatal outcome - birth height
Zeitfenster: At birth
|
The height (in cm) at birth of the newborn will be recorded.
|
At birth
|
|
Perinatal outcome - sex
Zeitfenster: At birth
|
The sex of the newborn will be recorded.
|
At birth
|
|
Perinatal outcome - perinatal mortality
Zeitfenster: At birth
|
The perinatal mortality will be recorded.
|
At birth
|
|
Perinatal outcome - five minutes Apgar score
Zeitfenster: At birth
|
The five minutes Apgar score will be recorded.
|
At birth
|
|
Perinatal outcome - cesarean section rate
Zeitfenster: At birth.
|
Cesarean section rate will be recorded.
|
At birth.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Stéphanie Nicolian, Midewife, Assistance Publique - Hôpitaux de Paris
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. September 2017
Primärer Abschluss (Voraussichtlich)
1. Januar 2019
Studienabschluss (Voraussichtlich)
1. Mai 2019
Studienanmeldedaten
Zuerst eingereicht
23. Mai 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juni 2017
Zuerst gepostet (Tatsächlich)
21. Juni 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Juni 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Juni 2017
Zuletzt verifiziert
1. April 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P150951
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .