Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

NCT05000528 | Recruiting

• 1 other identifier: NIMAO/2020-2/BA-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

• Improvement in chronic insomnia between groups

  Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion

  Day 28

Secondary Outcomes (20)

• Change in total sleeping time between groups

  Day 28

• Change in time in bed between groups

  Day 28

• Change in effective sleep

  Day 28

• Change in sleep latency

  Day 28

• Change in intra-sleep time

  Day 28

Study Arms (2)

Therapeutic education

EXPERIMENTAL

Other: therapeutic education; Other: Actimetry

Individualized consultation

ACTIVE COMPARATOR

Other: Actimetry

Interventions

therapeutic education OTHER

In groups of 5-6, patients will have a one-day therapeutic training session comprising 4 workshops: how to create a sleep agenda; normal sleep; sleep hygiene; medical treatments.

Therapeutic education

Actimetry OTHER

once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention

Individualized consultation; Therapeutic education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Beatriz Abril

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Abril

CONTACT

04.66.68.77.30; beatriz.abril@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 11, 2021
• Study Start: September 30, 2022
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

FR (1)