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

January 18, 2023 updated by: Centre Hospitalier Henri Laborit

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Henri Laborit
        • Contact:
          • Antoinette Bonnaudeau
          • Phone Number: 0033 5 16 52 61 18

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Luminotherapy and Psychoeducation Program
Other: Luminotherapy and /or Psychoeducation Program
TO complete
Active Comparator: Psychoeducation Program
Other: Luminotherapy and /or Psychoeducation Program
TO complete

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Henri Laborit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02526-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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