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

11. maj 2026 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Standardized hypnotic taper and self-help program
Andet: 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).
Adfærdsmæssigt: 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.
Aktiv komparator: Standardized hypnotic taper only
Andet: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary hypnotics screening assessed during Visit 2
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary hypnotics screening assessed during Visit 3
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Bordeaux

Efterforskere

  • Studiestol: Antoine BENARD, MD-PhD, USMR - CHU de Bordeaux

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. oktober 2016

Primær færdiggørelse (Faktiske)

25. oktober 2019

Studieafslutning (Faktiske)

25. november 2019

Datoer for studieregistrering

Først indsendt

10. marts 2016

Først indsendt, der opfyldte QC-kriterier

21. marts 2016

Først opslået (Anslået)

28. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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).

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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