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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
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 26, 2021
Last Updated
January 18, 2023
Sponsor
Centre Hospitalier Henri Laborit
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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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