Nursing Care of Bipolar Patients With Sleeping Disorders... | NCT04917419

Studies
Nursing Care of Bipolar Patients With Sleeping Disorders Using Luminotherapy and /or Psychoeducation Program (BIPLUMINO)

NCT04917419

Sponsor

Centre Hospitalier Henri Laborit

Status

Recruiting

Last Update Posted

Jan 13, 2026Actual

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Bipolar Disorder

Interventions

Luminotherapy and /or Psychoeducation Program

Countries

France

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2022Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Feb 26, 2021

First Submission Date that Met QC Criteria

Jun 7, 2021

First Posted Date

Jun 8, 2021Actual

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

Jan 12, 2026

Last Update Posted Date

Jan 13, 2026Actual

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

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.

Detailed Description

Not provided

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

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Luminotherapy and Psychoeducation Program	Experimental		Other: Luminotherapy and /or Psychoeducation Program
Psychoeducation Program	Active Comparator		Other: Luminotherapy and /or Psychoeducation Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Luminotherapy and /or Psychoeducation Program	Other	TO complete	Luminotherapy and Psychoeducation Program Psychoeducation Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of days in-hospital	Number of days patients spent in the hospital	Day 0 to Day 365

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cécile BOISVERT	Contact	0033 5 16 52 61 18		cecile.boisvert@ch-poitiers.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Henri Laborit	Recruiting	Poitiers		86021	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided