InsomniaPROPERSOMNCT02720458
Self Help Program for Hypnotics Withdrawal in Insomniac Patients
A study testing Standardized gradual hypnotic taper and Short-term simple self-help program in people with Insomnia, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Standardized gradual hypnotic taper and Short-term simple self-help program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesFrance
- Study dates
- 4 Oct 2016to 25 Nov 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient complaining of persistent insomnia without co-morbidities (DSM-5) and treated for at least 3 months with monotherapy of:
- Zopiclone or Zolpidem with usual doses (3.5 doses per week at least to a maximum of 14 per week) OR Intermediate half-life benzodiazepines included in the appendix 1 list with usual doses (3.5 doses per week at least to a maximum of 14 per week)
- Motivated to stop hypnotic treatment (score >5 on a 1 to 10 degrees VAS)
- 18 to 75 years old,
- Man or woman,
- Having an internet connection,
- Affiliated to a national health service,
- Having given written informed consent to participate in the trial.
Who cannot join
- Patient with 2 psychotropic drugs or more taken daily for insomnia complaints (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder).
- Patient not believing in short-term simple self-help program
- Insomnia with comorbidities other than a stabilized mood and/or anxiety disorder
- Night and shift-workers,
- Current Psychiatric disorder : mood disorder (depression, bipolar disorder) with a BDI score > 19, anxiety disorder, psychosis
- All sleep disorders other than persistent insomnia (clinical interview),
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- Progressive neurological diseases that include restless legs syndrome,
- Unstable Cardiovascular disease,
- Unstable respiratory or endocrinological diseases (clinical interview),
- Drug addiction, alcohol addiction during the previous 6 months (clinical interview),
- Having undertaken trans-meridian travel (± 3H) in the previous 1 month
- Pregnant or lactating woman,
- Current participation in psychotherapy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Bordeaux
Bordeaux, 33076
APHP Hôpital Raymond Poincaré
Garches, 92380
CHRU de Lille
Lille, 59037
CHU de Montpellier
Montpellier, 34295
AP-HP Hôpital Pitié-Salpétrière
Paris, 75013
APHP Hôtel-Dieu de Paris
Paris, 75181
About this study
Official title: Self-help Program for Hypnotics Withdrawal in Chronic Insomniac Patients: A Randomized Controlled Clinical Trial
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. French Health authorities recommend restricting the consumption of both hypnotics to no more than 4 weeks, considering their potential adverse effects (memory impairment, altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence. However, it appears that a majority of patients become chronic users. Therefore, discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound insomnia).
Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT) principles improve sleep and daily life quality leading to hypnotic taper and maintain of hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. This therapy is dependent on a therapeutic alliance between practitioner and patient. Unfortunately, there are an insufficient number of trained CBT experts especially in France.
Read more
The implementation of an internet-delivered self-help program based on time-in-bed restriction and stimulus control may be an issue within the context of general practice.
Online programs based on CBT principles have been proved to be effective in improving the sleep and daytime functioning in this population, but the studies were realized in small patients groups.
Investigators hypothesis is that a simple and internet-delivered short-term program based on sleep restriction therapy and stimulus control (following to a GP consultation) may facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia disorder still reporting sleep complaints in comparison with a tapering alone (no access to the self-help program).
- Conditions
- Insomnia
- Being tested
- Standardized gradual hypnotic taper, Short-term simple self-help program
- Keywords
- Hypnotics withdrawal in insomniac patients, Cognitive-Behavioural Therapy (CBT), Internet-delivered self-help program, Sleep restriction, Stimulus control, Half-life benzodiazepine, Z-drug
- 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.
Standardized gradual hypnotic taperOther
The gradual hypnotic taper is standardized and is adjusted depending on the hypnotic treatment and the initial weekly dose. The practitioner will give to the patient a calendar for the taper period with the specific dose for each day (name of hypnotic, quantity and dose of pills).
Short-term simple self-help programBehavioural
The short-term simple self-help program consists in:
- Restriction of time in bed
- Stimulus control instructions
The restriction of time in bed would be delivered by an e-health tool (web site). The patient will have to connect to the web site with an individual connexion password. He will connect every day to complete an on-line sleep diary during the period of the simple short-term behavioural program (5 weeks). After this period, patients will have the choice to continue connecting to the website and using the program or to stop using the program.
| Study group | Role | What they receive |
|---|---|---|
| Standardized hypnotic taper and self-help program | Experimental | Not described Receives: Other: Standardized gradual hypnotic taper; Behavioral: Short-term simple self-help program |
| Standardized hypnotic taper only | Active comparator | Not described Receives: Other: Standardized gradual hypnotic taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary hypnotics screening assessed during Visit 2
Urine will be frozen and afterwards analysed by a central laboratory (Unité de biologie médicale multidisciplinaire, CHU Bordeaux) for hypnotics (benzodiazepines and Z-drugs) using Gas Chromatography-Mass Spectrometry.
Measured: 7 weeks after randomization visit
Secondary outcomes (17)
Urinary hypnotics screening assessed during Visit 3
Urine will be frozen and afterwards analysed by a central laboratory (Unité de biologie médicale multidisciplinaire, CHU Bordeaux) for hypnotics (benzodiazepines and Z-drugs) using Gas Chromatography-Mass Spectrometry.
Measured: 17 weeks after randomization visit
Total sleep time obtained by actimetry
Measured: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Sleep efficiency obtained by actimetry
Measured: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Wake after sleep onset obtained by actimetry
Measured: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Sleep latency obtained by actimetry
Measured: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Total sleep time obtained by sleep diary
Measured: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Sleep efficiency obtained by sleep diary
Measured: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Wake after sleep onset obtained by sleep diary
Measured: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Sleep latency obtained by sleep diary
Measured: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Insomnia Severity Scale (ISI) score
Measured: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Leeds Sleep Evaluation Questionnaire (LSEQ) score
Measured: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Beck Depression Inventory Second Edition (BDI-II) score
Measured: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Beck anxiety Inventory (BAI) score
Measured: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Short-Form SF-36 Health Survey score
Measured: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ) score
Measured: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Self-efficiency visual analog scale score
Measured: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) and 7 weeks after randomization (Visit 2)
Reasons for non-compliance obtained during patient interview
Measured: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start4 Oct 2016
- Primary completion25 Oct 2019
- Study completion25 Nov 2019
Why it stopped: target number of inclusion not reached (65/256)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BENARD, MD-PhD, Study chair, USMR - CHU de Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720458
- Sponsor's protocol ID
- CHUBX 2014/35
- Other IDs
- 2015-000691-94, 2015
- Acronym
- PROPERSOM
- Status last verified
- Dec 2019
- First submitted
- 10 Mar 2016
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-help Program for Hypnotics Withdrawal in Chronic Insomniac Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02720458
- Acronym / sponsor ID
- PROPERSOM / CHUBX 2014/35
- Conditions
- Insomnia
- Keywords
- Hypnotics withdrawal in insomniac patients, Cognitive-Behavioural Therapy (CBT), Internet-delivered self-help program, Sleep restriction, Stimulus control, Half-life benzodiazepine, Z-drug
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: target number of inclusion not reached (65/256)
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 28 Mar 2016 (estimated)
- 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.
Persistent insomnia has a high prevalence in French general population affecting between 15.8 % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP) who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line treatment. French Health authorities recommend restricting the consumption of both hypnotics to no more than 4 weeks, considering their potential adverse effects (memory impairment, altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence. However, it appears that a majority of patients become chronic users. Therefore, discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound insomnia).
Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT) principles improve sleep and daily life quality leading to hypnotic taper and maintain of hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. This therapy is dependent on a therapeutic alliance between practitioner and patient. Unfortunately, there are an insufficient number of trained CBT experts especially in France.
The implementation of an internet-delivered self-help program based on time-in-bed restriction and stimulus control may be an issue within the context of general practice.
Online programs based on CBT principles have been proved to be effective in improving the sleep and daytime functioning in this population, but the studies were realized in small patients groups.
Investigators hypothesis is that a simple and internet-delivered short-term program based on sleep restriction therapy and stimulus control (following to a GP consultation) may facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia disorder still reporting sleep complaints in comparison with a tapering alone (no access to the self-help program).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized hypnotic taper and self-help program | Experimental | Other: Standardized gradual hypnotic taper, Behavioral: Short-term simple self-help program |
| Standardized hypnotic taper only | Active comparator | Other: Standardized gradual hypnotic taper |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient complaining of persistent insomnia without co-morbidities (DSM-5) and treated for at least 3 months with monotherapy of:
- Zopiclone or Zolpidem with usual doses (3.5 doses per week at least to a maximum of 14 per week) OR Intermediate half-life benzodiazepines included in the appendix 1 list with usual doses (3.5 doses per week at least to a maximum of 14 per week)
- Motivated to stop hypnotic treatment (score >5 on a 1 to 10 degrees VAS)
- 18 to 75 years old,
- Man or woman,
Key exclusion criteria (13 listed)
- Patient with 2 psychotropic drugs or more taken daily for insomnia complaints (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder).
- Patient not believing in short-term simple self-help program
- Insomnia with comorbidities other than a stabilized mood and/or anxiety disorder
- Night and shift-workers,
- Current Psychiatric disorder : mood disorder (depression, bipolar disorder) with a BDI score > 19, anxiety disorder, psychosis
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 |
|---|---|---|
| Standardized gradual hypnotic taperThe gradual hypnotic taper is standardized and is adjusted depending on the hypnotic treatment and the initial weekly dose. The practitioner will give to the patient a calendar for the taper period with the specific dose for each day (name of hypnotic, quantity and dose of pills). | Other | Standardized hypnotic taper and self-help program, Standardized hypnotic taper only |
| Short-term simple self-help programThe short-term simple self-help program consists in: * Restriction of time in bed * Stimulus control instructions The restriction of time in bed would be delivered by an e-health tool (web site). The patient will have to connect to the web site with an individual connexion password. He will connect every day to complete an on-line sleep diary during the period of the simple short-term behavioural program (5 weeks). After this period, patients will have the choice to continue connecting to the website and using the program or to stop using the program. | Behavioural | Standardized hypnotic taper and self-help program |
Primary outcome
Urinary hypnotics screening assessed during Visit 2
Time frame: 7 weeks after randomization visit
Urine will be frozen and afterwards analysed by a central laboratory (Unité de biologie médicale multidisciplinaire, CHU Bordeaux) for hypnotics (benzodiazepines and Z-drugs) using Gas Chromatography-Mass Spectrometry.
17 secondary outcomes
Urinary hypnotics screening assessed during Visit 3
Time frame: 17 weeks after randomization visit
Total sleep time obtained by actimetry
Time frame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Sleep efficiency obtained by actimetry
Time frame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Wake after sleep onset obtained by actimetry
Time frame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Sleep latency obtained by actimetry
Time frame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Total sleep time obtained by sleep diary
Time frame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Sleep efficiency obtained by sleep diary
Time frame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Wake after sleep onset obtained by sleep diary
Time frame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Sleep latency obtained by sleep diary
Time frame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Insomnia Severity Scale (ISI) score
Time frame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Leeds Sleep Evaluation Questionnaire (LSEQ) score
Time frame: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Beck Depression Inventory Second Edition (BDI-II) score
Time frame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Beck anxiety Inventory (BAI) score
Time frame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Short-Form SF-36 Health Survey score
Time frame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ) score
Time frame: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Self-efficiency visual analog scale score
Time frame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) and 7 weeks after randomization (Visit 2)
Reasons for non-compliance obtained during patient interview
Time frame: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Results and safety
The study was stopped early (reason given: target number of inclusion not reached (65/256)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).
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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.
Antoine BENARD, MD-PhD study chair
USMR - CHU de Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized gradual hypnotic taper and Short-term simple self-help program in people with Insomnia, run by University Hospital, Bordeaux at 6 sites 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 was stopped early (reason given: target number of inclusion not reached (65/256)). Results are not available in the source record.
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?
Urinary hypnotics screening assessed during Visit 2 (time frame: 7 weeks after randomization visit). 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 30 Jul 2026.