Back to resultsEffects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring yoga, sleep quality, sleep quantity, sleep efficiency, insomnia
Eligibility Criteria
Inclusion Criteria:
-primary insomnia
Exclusion Criteria:
- shift work,
- associated sleep disorder (sleep apnea, narcolepsy,..)
Sites / Locations
- CHu Saint Pierre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga
Arm Description
Patients receiving Yoga lessons for 3 months
Outcomes
Primary Outcome Measures
total sleep time
total sleep time measured by polysomnography and actigraphy
Secondary Outcome Measures
sleep latency
sleep latency measured by polysomnography and actigraphy
sleep efficiency
sleep efficiency measured by polysomnography and actigraphy
wake after sleep onset
wake after sleep onset measured by polysomnography and actigraphy
Full Information
NCT ID
NCT03314441
First Posted
October 16, 2017
Last Updated
September 1, 2021
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT03314441
Brief Title
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
Official Title
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the effects of regular Viniyoga in patients suffering from primary insomnia.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
yoga, sleep quality, sleep quantity, sleep efficiency, insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Description
Patients receiving Yoga lessons for 3 months
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
Primary Outcome Measure Information:
Title
total sleep time
Description
total sleep time measured by polysomnography and actigraphy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
sleep latency
Description
sleep latency measured by polysomnography and actigraphy
Time Frame
3 months
Title
sleep efficiency
Description
sleep efficiency measured by polysomnography and actigraphy
Time Frame
3 months
Title
wake after sleep onset
Description
wake after sleep onset measured by polysomnography and actigraphy
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-primary insomnia
Exclusion Criteria:
shift work,
associated sleep disorder (sleep apnea, narcolepsy,..)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Bruyneel, MD, PhD
Organizational Affiliation
CHU St Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHu Saint Pierre
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35421962
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Regular Practice of Yoga on Subjective and Objective Sleep Quality in Primary Insomnia
We'll reach out to this number within 24 hrs