Hypnotic; Sleep DisorderNCT05069285
A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications
A study testing self-help book and sleep hygiene advice in people with Hypnotic; Sleep Disorder, run by University of Bergen at 1 site in Norway.
Trial summary
The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypnotic; Sleep Disorder
- What is being tested?
- self-help book and sleep hygiene advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteNorway
- Study dates
- 10 May 2023to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Use of sleep medications on prescription or OTC during the last 6 months
Who cannot join
- Below 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing a Self-help Book Focusing on Cognitive Behavioral Therapy for Insomnia With Standard Sleep Hygiene Advice Among Patients Using Hypnotics
The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.
Read the detailed description
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia compared to the effect of sleep hygiene advice in patients using sleep medications. 150 patients will be randomized to receive either the book (75 patients) or the sleep hygiene advice (75 patients). Patients will fill questionnaires about sleep and health problems at baseline and after 3-6 months after receiving the written material. The main aims are to assess whether a self-help book is more effective in reducing sleep medication use and sleep problems.
- Conditions
- Hypnotic; Sleep Disorder
- Being tested
- self-help book, sleep hygiene advice
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-help bookOther
information and advice given in the self-help book
sleep hygiene adviceOther
information and advice given on the sheet of paper with sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Self-help book | Experimental | A self-help book for insomnia (written in Norwegian) Receives: Other: self-help book |
| Sleep hygiene advice | Active comparator | A sheet of paper with standard sleep hygiene advice Receives: Other: sleep hygiene advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of hypnotics assessed as days per week
Self-reported sleep medication use (days of use per week,0-7)
Measured: 3-6 months
Insomnia severity assessed with Insomnia Severity Index
Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep
Measured: 3-6 months
Insomnia severity assessed with Bergen Insomnia Scale
Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start10 May 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypnotic; Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjorn Bjorvatn, University of Bergen
- Investigators
- Bjørn Bjorvatn, MD PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069285
- Sponsor's protocol ID
- PraksisNettRCT2022
- Status last verified
- Jun 2024
- First submitted
- 23 Sep 2021
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing a Self-help Book Focusing on Cognitive Behavioral Therapy for Insomnia With Standard Sleep Hygiene Advice Among Patients Using Hypnotics
- ClinicalTrials.gov ID
- NCT05069285
- Acronym / sponsor ID
- PraksisNettRCT2022
- Conditions
- Hypnotic; Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.
Detailed description
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia compared to the effect of sleep hygiene advice in patients using sleep medications. 150 patients will be randomized to receive either the book (75 patients) or the sleep hygiene advice (75 patients). Patients will fill questionnaires about sleep and health problems at baseline and after 3-6 months after receiving the written material. The main aims are to assess whether a self-help book is more effective in reducing sleep medication use and sleep problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help book | Experimental | Other: self-help bookA self-help book for insomnia (written in Norwegian) |
| Sleep hygiene advice | Active comparator | Other: sleep hygiene adviceA sheet of paper with standard sleep hygiene advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Use of sleep medications on prescription or OTC during the last 6 months
Key exclusion criteria (1 listed)
- Below 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-help bookinformation and advice given in the self-help book | Other | Self-help book |
| sleep hygiene adviceinformation and advice given on the sheet of paper with sleep hygiene | Other | Sleep hygiene advice |
Primary outcome
Use of hypnotics assessed as days per week
Time frame: 3-6 months
Self-reported sleep medication use (days of use per week,0-7)
Insomnia severity assessed with Insomnia Severity Index
Time frame: 3-6 months
Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep
Insomnia severity assessed with Bergen Insomnia Scale
Time frame: 3-6 months
Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjørn Bjorvatn, MD PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-help book and sleep hygiene advice in people with Hypnotic; Sleep Disorder, run by University of Bergen 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 1 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: finished, as of the sponsor's last update on 10 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of hypnotics assessed as days per week (time frame: 3-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.