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Self Help Program for Hypnotics Withdrawal in Insomniac Patients (PROPERSOM)

29 juillet 2026 mis à jour par: University Hospital, Bordeaux

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.

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).

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

62

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux
      • Garches, France, 92380
        • APHP Hôpital Raymond Poincaré
      • Lille, France, 59037
        • CHRU de Lille
      • Montpellier, France, 34295
        • CHU de Montpellier
      • Paris, France, 75013
        • AP-HP Hopital Pitie-Salpetriere
      • Paris, France, 75181
        • APHP Hôtel-Dieu de Paris

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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),
  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Standardized hypnotic taper and self-help program
Autre: Standardized gradual hypnotic taper
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).
Comportemental: Short-term simple self-help program

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.
Comparateur actif: Standardized hypnotic taper only
Autre: Standardized gradual hypnotic taper
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Urinary hypnotics screening assessed during Visit 2
Délai: 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.
7 weeks after randomization visit

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Urinary hypnotics screening assessed during Visit 3
Délai: 17 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 weeks after randomization visit
Total sleep time obtained by actimetry
Délai: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Sleep efficiency obtained by actimetry
Délai: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Wake after sleep onset obtained by actimetry
Délai: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Sleep latency obtained by actimetry
Délai: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
Total sleep time obtained by sleep diary
Délai: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Sleep efficiency obtained by sleep diary
Délai: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Wake after sleep onset obtained by sleep diary
Délai: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Sleep latency obtained by sleep diary
Délai: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
Insomnia Severity Scale (ISI) score
Délai: 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)
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
Délai: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Beck Depression Inventory Second Edition (BDI-II) score
Délai: 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)
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
Délai: 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)
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
Délai: 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)
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
Délai: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Self-efficiency visual analog scale score
Délai: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) and 7 weeks after randomization (Visit 2)
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
Délai: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Bordeaux

Les enquêteurs

  • Chaise d'étude: Antoine BENARD, MD-PhD, USMR - CHU de Bordeaux

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 octobre 2016

Achèvement primaire (Réel)

25 octobre 2019

Achèvement de l'étude (Réel)

25 novembre 2019

Dates d'inscription aux études

Première soumission

10 mars 2016

Première soumission répondant aux critères de contrôle qualité

21 mars 2016

Première publication (Estimé)

28 mars 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 décembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CHUBX 2014/35
  • 2015-000691-94 (Numéro EudraCT)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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).

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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