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Harmful Use of HypnoticBI-sleepNCT06032715

Brief Intervention for Sleep Medication Misuse Among Elderly

A study testing BI (Brief Intervention) in people with Harmful Use of Hypnotic, run by University Hospital, Akershus at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Harmful Use of Hypnotic
What is being tested?
BI (Brief Intervention)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteNorway
Study dates
9 Oct 2023to 30 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-reported use of Z-hypnotics > 4 days per week and > 4 weeks

Who cannot join

  • diagnosis of dementia,
  • diagnosis of psychosis,
  • diagnosis of major depression,
  • diagnosis of delirium,
  • unable to give informed consent,
  • insufficient Norwegian language capacity to complete tests

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tahreem G Siddiqui, PhD contact

90600984 ext. +47

tahs@ahus.no

Norway1 site, 1 recruiting

  • Akershus University Hospital

    Lørenskog

    C Lundqvist, MD, PhD

    Christofer Lundqvist, MD, PhD

    Recruiting

Other trials in Norway

About this study

Official title: Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly

Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.

Read the detailed description

Two armed study with controlled masked first part over 6 months. Active arm is with Brief Intervention for inappropriate use of Z-hypnotics among elderly with intervention delivered by trained GPs. Control arm is for patients handled by their (non-trained) GPs with business as usual (BAU). Main outcome is 6 weeks after intervention with additional data collection points after 6 months (blinded) and long-term follow-up to 12 months (open). After 6 months there will be an open single crossover as BAU GPs will then also receive training in the Brief Intervention method.

Baseline assessments are limited to self reports and automatic sleep assessment with actigraphy to avoid assessment effects. Follow-up at main outcome time point is in person, some outcomes are also by telephone assessment and compared to baseline prior to intervention (e g Actigraphy assessment.

Being tested
BI (Brief Intervention)
Keywords
Z-hypnotics, insomnia, sleep, side effects, cognitive function, pain, behavioral intervention, dependence, quality of life
Medical subject headings
Sleep Initiation and Maintenance Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI (Brief Intervention)Behavioural

    Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics

Study groups in NCT06032715
Study groupRoleWhat they receive
BI (Brief Intervention)Active comparatorPatients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.
Receives: Behavioral: BI (Brief Intervention)
BAU (Business as usual)No interventionPatients whose GPs have not yet been taught the BI intervention. Patients only assessed in parallel with BI group by masked assessors using same instruments as for active comparator. This group also constitutes an open cross-over group to active intervention once the masked 6 months phase is completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inappropriate Z-hypnotics use

    Proportion of patients with prolonged use of Z-hypnotics

    Measured: 6 weeks

Secondary outcomes (9)

  1. Pain visual analogue scale (VAS)

    VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))

    Measured: 6 weeks

  2. Cognitive function

    Cognistat test total score (0-84, 84 best)

    Measured: 6 weeks

  3. Cognitive function

    Cognistat test total score (0-84, 84 best)

    Measured: 6 months

  4. Experience of sleep

    Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .)

    Measured: 6 weeks

  5. Experience of sleep

    Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .)

    Measured: 6 months

  6. Sleep efficiency (random subpopulation)

    Actigraphy assessed before and after intervention

    Measured: 6 weeks

  7. Change compared to baseline of Z-hypnotics use

    Proportion of patients with prolonged use of Z-hypnotics

    Measured: 6 weeks

  8. Change compared to baseline of Z-hypnotics use

    Proportion of patients with prolonged use of Z-hypnotics

    Measured: 6 months

  9. Inappropriate Z-hypnotics use

    Proportion of patients with prolonged use of Z-hypnotics

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start9 Oct 2023
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel masked and controlled first part intervention vs Business as usual with follow-up after 6 months by masked assessors. Subsequently open single cross-over of business as usual patients to also receive the same intervention.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032715
Sponsor's protocol ID
BI-sleep
Acronym
BI-sleep
Status last verified
Nov 2024
First submitted
17 Aug 2023
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11.

    PubMed 25112307

  • Frich JC, Kristoffersen ES, Lundqvist C. GPs' experiences with brief intervention for medication-overuse headache: a qualitative study in general practice. Br J Gen Pract. 2014 Sep;64(626):e525-31. doi: 10.3399/bjgp14X681313.

    PubMed 25179065

  • Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8.

    PubMed 26645391

  • Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Lasting improvement of medication-overuse headache after brief intervention - a long-term follow-up in primary care. Eur J Neurol. 2017 Jul;24(7):883-891. doi: 10.1111/ene.13318. Epub 2017 May 23.

    PubMed 28544265

  • Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3.

    PubMed 31234786

  • Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432.

    PubMed 32718926

  • Siddiqui TG, Cheng S, Mellingsaeter M, Grambaite R, Gulbrandsen P, Lundqvist C, Gerwing J. "What should I do when I get home?" treatment plan discussion at discharge between specialist physicians and older in-patients: mixed method study. BMC Health Serv Res. 2020 Nov 3;20(1):1002. doi: 10.1186/s12913-020-05860-9.

    PubMed 33143713

  • Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26.

    PubMed 34913326

  • Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022.

    PubMed 35239678

  • Siddiqui TG, Simonsen THB, Lie Selle M, Lundqvist C. Brief intervention for inappropriate z-hypnotics use in older adults: a before and after intervention study in primary care. Scand J Prim Health Care. 2026 Dec;44(1):2660168. doi: 10.1080/02813432.2026.2660168. Epub 2026 Apr 24.

    PubMed 42031000

  • Siddiqui TG, Simonsen TB, Bjelkaroy MT, Selle ML, Lundqvist C. A brief intervention to discontinue inappropriate z-hypnotics use by older patients in primary care: a randomised controlled trial. BMC Prim Care. 2026 Feb 13;27(1):97. doi: 10.1186/s12875-026-03212-w.

    PubMed 41680650

Questions about this trial

What is this clinical trial studying?

A study testing BI (Brief Intervention) in people with Harmful Use of Hypnotic, run by University Hospital, Akershus at 1 site in Norway.

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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tahreem G Siddiqui, PhD (90600984 ext. +47, tahs@ahus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inappropriate Z-hypnotics use (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06032715, which also lists 11 linked publications.

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 15 Nov 2024.

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