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Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia (ETP-INSOMNIE)

C

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Other: therapeutic education
Other: Actimetry

Study type

Interventional

Funder types

Other

Identifiers

NCT05000528
NIMAO/2020-2/BA-1

Details and patient eligibility

About

20 to 30% of the general population suffers from chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment, but unfortunately its implementation is complex. Long waiting times for a consultation / exploration, too short a consultation period, non-reimbursement of specialists and a lack of trained staff make the current care of insomniac patients difficult. Patients are thus treated late, often with heavy drug treatment, dependence on sleeping pills, difficult withdrawal and / or reactive mood disorders. The treatment is therefore limited to advice on sleep hygiene and a restriction of time spent in bed without ultimately intervening in the cognitive domain. Therapeutic education consists of empowering the patient in the management of chronic insomnia through group education workshops. The patient learns the principles of normal sleep, the way in which sleep evolves with aging, the dangers of treatments as well as the rules of sleep hygiene and the behaviors to modify to sleep well. In addition to benefiting from sharing of experience with other patients, therapeutic education makes the care pathway smoother and considerably reduces the long waiting times of the traditional care pathway in consultation.

The study investigators hypothesize that therapeutic education is more effective as a treatment for chronic insomnia than traditional management in individualized consultation (IC). Thus, therapeutic education could constitute an effective alternative to CBT.

Enrollment

44 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patient must have given their free and informed consent
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient must understand and read French
  • Patient with ICSD-3 diagnostic criteria for chronic insomnia: ISI score > 14/28.

Exclusion criteria

  • Patient with cognitive impairment as assessed by the investigator
  • Patient with shift work
  • Patients scoring > 10/24 on the Epworth sleepiness scale
  • Patient suffering from medical or psychiatric illnesses which may, in the opinion of the investigator, compromise the subject's state of health or ability to participate in the study.
  • Patient with chronic alcohol consumption or drug abuse
  • Patient unable to express consent.
  • Pregnant, parturient or breastfeeding patient.
  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Therapeutic education
Experimental group
Treatment:
Other: Actimetry
Other: therapeutic education
Individualized consultation
Active Comparator group
Treatment:
Other: Actimetry

Trial contacts and locations

1

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Central trial contact

Beatriz Abril

Data sourced from clinicaltrials.gov

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