Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO) (BIPLUMINO)
Primary Purpose
Bipolar Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Luminotherapy and /or Psychoeducation Program
Sponsored by
About this trial
This is an interventional supportive care trial for Bipolar Disorder
Eligibility Criteria
Main inclusion Criteria:
- Bipolar disorder (type 1 and 2 according to DSM V)
- Mood Disorder Questionnaire MDQ ˂ 7
- Sleeping and Circadian Rhythms Disorders
- Under treatment
Main exclusion Criteria:
- No addiction except for tobacco
- Narcolepsy
- Sleep Apnea
- Psychiatric comorbidities
- Suicidal ideation
Sites / Locations
- Centre Hospitalier Henri LaboritRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Luminotherapy and Psychoeducation Program
Psychoeducation Program
Arm Description
Outcomes
Primary Outcome Measures
Number of days in-hospital
Number of days patients spent in the hospital
Secondary Outcome Measures
Full Information
NCT ID
NCT04917419
First Posted
February 26, 2021
Last Updated
January 18, 2023
Sponsor
Centre Hospitalier Henri Laborit
1. Study Identification
Unique Protocol Identification Number
NCT04917419
Brief Title
Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO)
Acronym
BIPLUMINO
Official Title
Prise en Charge infirmière Des Anomalies du Sommeil et du Rythme Circadien Par luminothérapie et/ou un Programme Court de psychoéducation Chez Des Patients Souffrant de Troubles Bipolaires
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit
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
Bipolar disorder affects more than 1% of the population. This pathology is considered as one of the most serious psychiatric disorder because of it is high suicide rates. It impacts patients life quality on many aspects, and specially their sleeping and circadian Rhythms. This can lead to more severe symptoms up to for thymic relapses. It was shown that Luminotherapy and Psychoeducation Program have a positive impact on these type of symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Luminotherapy and Psychoeducation Program
Arm Type
Experimental
Arm Title
Psychoeducation Program
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Luminotherapy and /or Psychoeducation Program
Intervention Description
TO complete
Primary Outcome Measure Information:
Title
Number of days in-hospital
Description
Number of days patients spent in the hospital
Time Frame
Day 0 to Day 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion Criteria:
Bipolar disorder (type 1 and 2 according to DSM V)
Mood Disorder Questionnaire MDQ ˂ 7
Sleeping and Circadian Rhythms Disorders
Under treatment
Main exclusion Criteria:
No addiction except for tobacco
Narcolepsy
Sleep Apnea
Psychiatric comorbidities
Suicidal ideation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cécile BOISVERT
Phone
0033 5 16 52 61 18
Email
cecile.boisvert@ch-poitiers.fr
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoinette Bonnaudeau
Phone
0033 5 16 52 61 18
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO)
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