Effects of Regular Practice of Yoga on Subjective and Obj... | NCT03314441

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

NCT03314441

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Status

Completed

Last Update Posted

Sep 2, 2021Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Primary Insomnia

Interventions

Yoga

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2017Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

May 31, 2021Actual

First Submitted Date

Oct 16, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2021

Last Update Posted Date

Sep 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marie Bruyneel, Chef de Clinique, Centre Hospitalier Universitaire Saint PierrePrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire Saint PierreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Yoga	Experimental	Patients receiving Yoga lessons for 3 months	Behavioral: Yoga

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yoga	Behavioral	4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.	Yoga

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
sleep latency	sleep latency measured by polysomnography and actigraphy	3 months
sleep efficiency	sleep efficiency measured by polysomnography and actigraphy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-primary insomnia

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marie Bruyneel, MD, PhD	CHU St Pierre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHu Saint Pierre		Brussels		1000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35421962	Derived	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.

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies