Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia

September 1, 2021 updated by: Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
The purpose of the study is to assess the effects of regular Viniyoga in patients suffering from primary insomnia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Insomnia is very prevalent in Europe (14-27%). Cognitive behavioral therapy is the treatment of choice in patients suffering from primary insomnia, allowing to obtain a long term (2 years) sleep quality improvements in 62% of patients. Yoga is another behavioral therapy that have shown benefits in patients suffering from anxiety disorders. Few studies have been focused on yoga benefits in sleep disorders. The purpose of the study is to assess the effects of regular Viniyoga on sleep quality (subjective and objective) in patients suffering from primary insomnia.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • CHU Saint Pierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-primary insomnia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Yoga
Patients receiving Yoga lessons for 3 months
Behavioral: Yoga
4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total sleep time
Time Frame: 3 months
total sleep time measured by polysomnography and actigraphy
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep latency
Time Frame: 3 months
sleep latency measured by polysomnography and actigraphy
3 months
sleep efficiency
Time Frame: 3 months
sleep efficiency measured by polysomnography and actigraphy
3 months
wake after sleep onset
Time Frame: 3 months
wake after sleep onset measured by polysomnography and actigraphy
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

  • Principal Investigator: Marie Bruyneel, MD, PhD, Chu St Pierre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2017

Primary Completion (ACTUAL)

December 30, 2020

Study Completion (ACTUAL)

May 31, 2021

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE076201733641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Insomnia

Clinical Trials on Yoga

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe