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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).

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

62

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Standardized hypnotic taper and self-help program
他の：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).
行動：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.
アクティブコンパレータ：Standardized hypnotic taper only
他の：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).

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Urinary hypnotics screening assessed during Visit 2
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Urinary hypnotics screening assessed during Visit 3
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Hospital, Bordeaux

捜査官

  • スタディチェア：Antoine BENARD, MD-PhD、USMR - CHU de Bordeaux

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年10月4日

一次修了 (実際)

2019年10月25日

研究の完了 (実際)

2019年11月25日

試験登録日

最初に提出

2016年3月10日

QC基準を満たした最初の提出物

2016年3月21日

最初の投稿 (推定)

2016年3月28日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30日

QC基準を満たした最後の更新が送信されました

2026年7月29日

最終確認日

2019年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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).

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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