NCT03194191

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 28, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

May 23, 2017

Last Update Submit

June 27, 2017

Conditions

Insomnia

Keywords

InsomniaPregnancyAcupunctureInsomnia severity indexPittsburgh Sleep Quality IndexAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • Insomnia severity index (ISI)

    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

Secondary Outcomes (15)

  • Pittsburgh Sleep Quality Index (PSQI)

    Inclusion visit and 5 weeks after the first acupuncture session

  • Hospital Anxiety and Depression Scale (HADS)

    Inclusion visit and 5 weeks after the first acupuncture session

  • Cumulated dose of each psychotropic medicine

    Inclusion visit and 5 weeks after the first acupuncture session

  • Cumulated dose of alcohol

    Inclusion visit and 5 weeks after the first acupuncture session

  • Cumulated dose of tobacco

    Inclusion visit and 5 weeks after the first acupuncture session

  • +10 more secondary outcomes

Study Arms (2)

Regular acupuncture needles

EXPERIMENTAL

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

Sham acupuncture needles

SHAM COMPARATOR

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

Interventions

Acupuncture needlesDEVICE

The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes

Regular acupuncture needlesSham acupuncture needles

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Singleton pregnancy
  • Gestational age ≥ 16 weeks + 0 day and ≤ 32 weeks + 6 days
  • Insomnia Severity Index ≥ 10
  • Patient understanding the study
  • Informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Stéphanie Nicolian, Midewife

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Nicolian, Midewife

CONTACT

0033 6 25 71 08 64snicolian@yahoo.fr

Marc Dommergues, PUPH

CONTACT

0033 6 08 48 69 25marc.dommergues@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind (patient blinded to intervention)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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,
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2017

First Posted

June 21, 2017

Study Start

September 1, 2017

Primary Completion

January 1, 2019

Study Completion

May 1, 2019

Last Updated

June 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share