Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

Recruiting now · Not applicable

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

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.

Key facts

Study ID

NCT05000528

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

44

Starts

2022-09-30

Expected to finish

2025-09-29

Last updated by the study team

2024-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CHU de NIMES — Nîmes, France (enrolling)

Full record on ClinicalTrials.gov

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