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

2026年7月29日 更新者：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).

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

62

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Standardized hypnotic taper and self-help program
其他：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).
行为的：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.
有源比较器：Standardized hypnotic taper only
其他：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Urinary hypnotics screening assessed during Visit 2
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Urinary hypnotics screening assessed during Visit 3
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Bordeaux

调查人员

  • 学习椅：Antoine BENARD, MD-PhD、USMR - CHU de Bordeaux

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年10月4日

初级完成 (实际的)

2019年10月25日

研究完成 (实际的)

2019年11月25日

研究注册日期

首次提交

2016年3月10日

首先提交符合 QC 标准的

2016年3月21日

首次发布 (估计的)

2016年3月28日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2019年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

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

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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).

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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