Sleep Initiation and Maintenance DisordersETP-INSOMNIENCT05000528
Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia
A study testing therapeutic education and Actimetry in people with Sleep Initiation and Maintenance Disorders, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- therapeutic education and Actimetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2022to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique
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.
- Being tested
- therapeutic education, Actimetry
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic educationOther
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.
ActimetryOther
once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic education | Experimental | Not described Receives: Other: therapeutic education; Other: Actimetry |
| Individualized consultation | Active comparator | Not described Receives: Other: Actimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in chronic insomnia between groups
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
Measured: Day 28
Secondary outcomes (20)
Change in total sleeping time between groups
Change in total sleeping time (minutes) from inclusion
Measured: Day 28
Change in time in bed between groups
Change in time in bed (minutes) from inclusion
Measured: Day 28
Change in effective sleep
Time between going to bed and falling asleep (minutes). Average time for the 2 weeks following inclusion versus the 2 weeks preceding the study end measured by actimetry bracelet
Measured: Day 28
Change in sleep latency
% total sleeping time / time in bed. Average time for the 2 weeks following inclusion versus the 2 weeks preceding the study end measured by actimetry bracelet
Measured: Day 28
Change in intra-sleep time
Change in time between going to bed and falling asleep (minutes) since inclusion, data collected from patient sleep agenda
Measured: Day 28
Change in anxiety since baseline between groups
State-Trait Anxiety Inventory (STAI-Y). Self-questionnaire assessing anxiety-status (AE) reflecting the current emotional state and anxiety-trait (AT) reflecting the usual emotional state. Total score 20-80.
Measured: Day 28
Change in depression since baseline between groups
Beck Depression Inventory (BDI). The total score is obtained by adding the scores of the 13 items. This score will be between 0 and 63. The higher the score, the more depressed the subject is.
Measured: Day 28
Change in quality of life since baseline
Dysfunctional Beliefs and Attitudes about Sleep - 16 (DBAS-16). This self-questionnaire is composed of 16 items: Perceived consequences of insomnia (5 items), Worry/impotence about insomnia (6 items), Sleep expectations (2 items), Medication (3 items). The global score is an average of the scores of each item, ranging from 0 to 10. The higher the score, the more dysfunctional beliefs and attitudes about sleep
Measured: Day 28
Use of hypnotic drugs between groups
Yes/no for each type
Measured: Day 28
Use of anxiolytic drugs between groups
Yes/no for each type
Measured: Day 28
Dose of any hypnotic drugs taken between groups
Measured: Day 28
Dose of any anxiolytic drugs taken between groups
Measured: Day 28
Completion of therapeutic education sessions of patients in the therapeutic education group
Yes/no
Measured: Day 28
Length of workshops in the therapeutic education group
Minutes
Measured: Day 28
Problems encountered during workshops of patients in the therapeutic education group
Descriptive list made by investigator
Measured: Day 28
Patient-reported reason for refusal to participate in the therapeutic education group
Descriptive list of reasons given by the patient
Measured: Day 28
Improvement in chronic insomnia between groups
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
Measured: Month 4
Change in anxiety since baseline between groups
State-Trait Anxiety Inventory (STAI-Y). Self-questionnaire assessing anxiety-status (AE)
Measured: Month 4
Change in depression since baseline between groups
Beck Depression Inventory (BDI). The total score is obtained by adding the scores of the 13 items. This score will be between 0 and 63. The higher the score, the more depressed the subject is.
Measured: Month 4
Change in quality of life since baseline
Dysfunctional Beliefs and Attitudes about Sleep - 16 (DBAS-16). This self-questionnaire is composed of 16 items: Perceived consequences of insomnia (5 items), Worry/impotence about insomnia (6 items), Sleep expectations (2 items), Medication (3 items). The global score is an average of the scores of each item, ranging from 0 to 10. The higher the score, the more dysfunctional beliefs and attitudes about sleep
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start30 Sep 2022
- Primary completion30 Mar 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz Abril, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000528
- Sponsor's protocol ID
- NIMAO/2020-2/BA-1
- Acronym
- ETP-INSOMNIE
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique
- ClinicalTrials.gov ID
- NCT05000528
- Acronym / sponsor ID
- ETP-INSOMNIE / NIMAO/2020-2/BA-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic education | Experimental | Other: therapeutic education, Other: Actimetry |
| Individualized consultation | Active comparator | Other: Actimetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic educationIn 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. | Other | Therapeutic education |
| Actimetryonce from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention | Other | Individualized consultation, Therapeutic education |
Primary outcome
Improvement in chronic insomnia between groups
Time frame: Day 28
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
20 secondary outcomes
Change in total sleeping time between groups
Time frame: Day 28
Change in time in bed between groups
Time frame: Day 28
Change in effective sleep
Time frame: Day 28
Change in sleep latency
Time frame: Day 28
Change in intra-sleep time
Time frame: Day 28
Change in anxiety since baseline between groups
Time frame: Day 28
Change in depression since baseline between groups
Time frame: Day 28
Change in quality of life since baseline
Time frame: Day 28
Use of hypnotic drugs between groups
Time frame: Day 28
Use of anxiolytic drugs between groups
Time frame: Day 28
Dose of any hypnotic drugs taken between groups
Time frame: Day 28
Dose of any anxiolytic drugs taken between groups
Time frame: Day 28
Completion of therapeutic education sessions of patients in the therapeutic education group
Time frame: Day 28
Length of workshops in the therapeutic education group
Time frame: Day 28
Problems encountered during workshops of patients in the therapeutic education group
Time frame: Day 28
Patient-reported reason for refusal to participate in the therapeutic education group
Time frame: Day 28
Improvement in chronic insomnia between groups
Time frame: Month 4
Change in anxiety since baseline between groups
Time frame: Month 4
Change in depression since baseline between groups
Time frame: Month 4
Change in quality of life since baseline
Time frame: Month 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Abril principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic education and Actimetry in people with Sleep Initiation and Maintenance Disorders, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in chronic insomnia between groups (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.