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Recruiting NCT04917419

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

No phase Interventional Bipolar Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Luminotherapy and /or Psychoeducation Program.
Who it may be relevant to
Registry conditions: Bipolar Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other Luminotherapy and /or Psychoeducation Program
    TO complete

Primary outcome measures

  • Number of days in-hospital [Time frame: Day 0 to Day 365]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • Centre Hospitalier Henri Laborit — Poitiers

Identifiers

NCT: NCT04917419 · 2020-A02526-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗