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Pregnancy With Insomnia: a Trial of Acupuncture (GAS)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified April 2017 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT03194191
First received: May 23, 2017
Last updated: June 27, 2017
Last verified: April 2017
  Purpose

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.


Condition Intervention
Insomnia Device: Acupuncture needles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Participant
Masking Description:
Single blind (patient blinded to intervention)
Primary Purpose: Treatment
Official Title: Pregnancy With Insomnia: a Trial of Acupuncture

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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

  • Cumulated dose of each psychotropic medicine [ Time Frame: 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.

  • Cumulated dose of alcohol [ Time Frame: 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.

  • Cumulated dose of tobacco [ Time Frame: 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.

  • Cumulated dose of cannabis [ Time Frame: 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.

  • Cumulated dose of other recreational substances or medicine [ Time Frame: 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.

  • Difference in the frequency of restless leg syndrome [ Time Frame: 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:

    1. Desire to move the extremities usually associated with discomfort or disagreeable sensations in the extremities.
    2. 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.
    3. Symptoms are worse at rest with at least temporary relief by activity.
    4. Symptoms are worse later in the day or at night.

  • Perinatal outcome - Gestational age at birth [ Time Frame: At birth ]
    The gestational age at birth of the newborn will be recorded.

  • Perinatal outcome - birth weight [ Time Frame: At birth ]
    The weight (in gr) at birth of the newborn will be recorded.

  • Perinatal outcome - birth height [ Time Frame: At birth ]
    The height (in cm) at birth of the newborn will be recorded.

  • Perinatal outcome - sex [ Time Frame: At birth ]
    The sex of the newborn will be recorded.

  • Perinatal outcome - perinatal mortality [ Time Frame: At birth ]
    The perinatal mortality will be recorded.

  • Perinatal outcome - five minutes Apgar score [ Time Frame: At birth ]
    The five minutes Apgar score will be recorded.

  • Perinatal outcome - cesarean section rate [ Time Frame: At birth. ]
    Cesarean section rate will be recorded.


Estimated Enrollment: 60
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Acupuncture needles
The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes
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
Device: Acupuncture needles
The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03194191

Contacts
Contact: Stéphanie Nicolian, Midewife 0033 6 25 71 08 64 snicolian@yahoo.fr
Contact: Marc Dommergues, PUPH 0033 6 08 48 69 25 marc.dommergues@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Stéphanie Nicolian, Midewife Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03194191     History of Changes
Other Study ID Numbers: P150951
Study First Received: May 23, 2017
Last Updated: June 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Insomnia
Pregnancy
Acupuncture
Insomnia severity index
Pittsburgh Sleep Quality Index
Anxiety
Depression

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 25, 2017