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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03314441
Other study ID # BE076201733641
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date May 31, 2021

Study information

Verified date September 2021
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 31, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: -primary insomnia Exclusion Criteria: - shift work, - associated sleep disorder (sleep apnea, narcolepsy,..)

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium CHu Saint Pierre Brussels

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary total sleep time total sleep time measured by polysomnography and actigraphy 3 months
Secondary sleep latency sleep latency measured by polysomnography and actigraphy 3 months
Secondary sleep efficiency sleep efficiency measured by polysomnography and actigraphy 3 months
Secondary wake after sleep onset wake after sleep onset measured by polysomnography and actigraphy 3 months
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