NCT03314441

Brief Summary

The purpose of the study is to assess the effects of regular Viniyoga in patients suffering from primary insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 8, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3.1 years

First QC Date

October 16, 2017

Last Update Submit

September 1, 2021

Conditions

Primary Insomnia

Keywords

yogasleep qualitysleep quantitysleep efficiencyinsomnia

Outcome Measures

Primary Outcomes (1)

  • total sleep time

    total sleep time measured by polysomnography and actigraphy

    3 months

Secondary Outcomes (3)

  • sleep latency

    3 months

  • sleep efficiency

    3 months

  • wake after sleep onset

    3 months

Study Arms (1)

Yoga

EXPERIMENTAL

Patients receiving Yoga lessons for 3 months

Behavioral: Yoga

Interventions

YogaBEHAVIORAL

4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.

Yoga

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary insomnia

You may not qualify if:

  • shift work,
  • associated sleep disorder (sleep apnea, narcolepsy,..)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu Saint Pierre

Brussels, 1000, Belgium

Location

Related Publications (1)

  • Turmel D, Carlier S, Bruyneel AV, Bruyneel M. Tailored individual Yoga practice improves sleep quality, fatigue, anxiety, and depression in chronic insomnia disorder. BMC Psychiatry. 2022 Apr 14;22(1):267. doi: 10.1186/s12888-022-03936-w.

    PMID: 35421962DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Marie Bruyneel, MD, PhD

    CHU St Pierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de Clinique

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 19, 2017

Study Start

November 8, 2017

Primary Completion

December 30, 2020

Study Completion

May 31, 2021

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)