InsomniaNCT06575998
Insomnia in Primary Care
A study testing Training and Pro-active identification in people with Insomnia, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Training and Pro-active identification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Sep 2024to 13 Mar 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients meeting any of the following criteria in the survey will be excluded from participation in this study:
- Shift work for individuals awakening outside the hours 4:00 A.M. and 10:00 A.M. or going to bed outside the hours of 8:00 P.M. and 2:00 A.M. more than twice a week
- Other sleep-wake disorders including chronic obstructive sleep apnea, bruxism and narcolepsy, restless leg syndrome and parasomnia.
- Current pregnancy
- Presence of epilepsy, schizophrenia, bipolar disorder, post-traumatic stress disorder or dementia in medical history
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333ZA
About this study
Official title: The Treatment of Insomnia in Primary Care: Evaluating and Improving Compliance to Clinical Practice Guidelines
The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).
- Conditions
- Insomnia
- Being tested
- Training, Pro-active identification
- Keywords
- Primary Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.
Pro-active identificationOther
Pro-active identification of patients with clinical insomnia symptoms. Patients receiving care from the participating practices will be asked to fill-out the Insomnia Severity Index (ISI).The ISI is used to identify patients with clinical insomnia symptoms in the general practice. Trained practices will receive feedback on the ISI for half of the patients with clinical symptoms according to the ISI.
| Study group | Role | What they receive |
|---|---|---|
| Training with pro-active identification | Experimental | For detailed description of the intervention, see the separate section on interventions. Receives: Other: Training; Other: Pro-active identification |
| Training without pro-active identification | Experimental | For detailed description of the intervention, see the separate section on interventions. Receives: Other: Training |
| Control | No intervention | Care as usual according to national applicable primary guide guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)
Change is measured linearly using the Insomnia Severity Index. Scores range from 0 to 28 points in which higher scores represent a worse outcome. Secondly, the categorically defined treatment response is established 2 months after baseline questionnaire (remission = ISI score < 11, ISI score reduction ≥ 8).
Measured: From baseline to measurements at 2, 6 and 12 months
Secondary outcomes (6)
Patient reported non-pharmacological 'sleep consultation'
Patient report of a sleep consultation (survey answer yes/no) combined with patient reported sleep medication use (survey answer yes/no).
Measured: 12 months after baseline questionnaire
Report by the PCP of a non-pharmacological 'sleep consultation'
PCP reported sleep consultation (survey answer yes/no) combined with PCP reported sleep medication use (survey answer yes/no).
Measured: 12 months after baseline questionnaire
Change in patient reported depression symptoms
Measured linearly using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27 points in which higher scores represent a worse outcome.
Measured: From baseline to measurements at 2, 6 and 12 months
Change in patient reported anxiety symptoms
Measured linearly using the General Anxiety Disorder Questionniare (GAD-7). Scores range from 0 to 21 points in which higher scores represent a worse outcome.
Measured: From baseline to measurements at 2, 6 and 12 months
Change in patient reported general health status
Measured with the Short Form-36 questionnaire (SF-36). Scores represent the percentage of total possible score achieved, ranging from 0 to 100. A higher score represents a better outcome.
Measured: From baseline to measurements at 2, 6 and 12 months
Change in report of sleep medication use
Patient reported use of sleep medication in the past two weeks (survey answer yes/no).
Measured: From baseline to measurements at 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start12 Sep 2024
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Model description
- The cluster randomization trial involves two randomization procedures. Firstly, on primary care practice level, practices will be randomized to intervention practice or control practice. Secondly, patients in the intervention practices will be randomized to pro-active identification or no identification. Pro-actively identified insomnia patients will be reported back to the PCP.
- Masking
- None (open label)
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, menumans, Leiden University Medical Center
- Investigators
- Dennis O. Mook-Kanamori, Principal investigator, Leiden University Medical CenterRutger A. Middenburg, Principal investigator, Leiden University Medical CenterMattijs E. Numans, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575998
- Sponsor's protocol ID
- N24.054
- Other IDs
- 80-83910-98-1158
- Status last verified
- Dec 2025
- First submitted
- 16 Aug 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the nature of the study blinding is not possible. Therefore, the data contains privacy sensitive information and only restricted access may be granted for unidentifiable parts of the data. It has yet to be decided which data can be acquired through restricted access.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Insomnia in Primary Care: Evaluating and Improving Compliance to Clinical Practice Guidelines
- ClinicalTrials.gov ID
- NCT06575998
- Acronym / sponsor ID
- N24.054
- Conditions
- Insomnia
- Keywords
- Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 28 Aug 2024 (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 goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The cluster randomization trial involves two randomization procedures. Firstly, on primary care practice level, practices will be randomized to intervention practice or control practice. Secondly, patients in the intervention practices will be randomized to pro-active identification or no identification. Pro-actively identified insomnia patients will be reported back to the PCP.
| Arm | Type | Receives |
|---|---|---|
| Training with pro-active identification | Experimental | Other: Training, Other: Pro-active identificationFor detailed description of the intervention, see the separate section on interventions. |
| Training without pro-active identification | Experimental | Other: TrainingFor detailed description of the intervention, see the separate section on interventions. |
| Control | No intervention | –Care as usual according to national applicable primary guide guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients meeting any of the following criteria in the survey will be excluded from participation in this study:
- Shift work for individuals awakening outside the hours 4:00 A.M. and 10:00 A.M. or going to bed outside the hours of 8:00 P.M. and 2:00 A.M. more than twice a week
- Other sleep-wake disorders including chronic obstructive sleep apnea, bruxism and narcolepsy, restless leg syndrome and parasomnia.
- Current pregnancy
- Presence of epilepsy, schizophrenia, bipolar disorder, post-traumatic stress disorder or dementia in medical history
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 |
|---|---|---|
| TrainingA 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia. | Other | Training with pro-active identification, Training without pro-active identification |
| Pro-active identificationPro-active identification of patients with clinical insomnia symptoms. Patients receiving care from the participating practices will be asked to fill-out the Insomnia Severity Index (ISI).The ISI is used to identify patients with clinical insomnia symptoms in the general practice. Trained practices will receive feedback on the ISI for half of the patients with clinical symptoms according to the ISI. | Other | Training with pro-active identification |
Primary outcome
Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)
Time frame: From baseline to measurements at 2, 6 and 12 months
Change is measured linearly using the Insomnia Severity Index. Scores range from 0 to 28 points in which higher scores represent a worse outcome. Secondly, the categorically defined treatment response is established 2 months after baseline questionnaire (remission = ISI score < 11, ISI score reduction ≥ 8).
6 secondary outcomes
Patient reported non-pharmacological 'sleep consultation'
Time frame: 12 months after baseline questionnaire
Report by the PCP of a non-pharmacological 'sleep consultation'
Time frame: 12 months after baseline questionnaire
Change in patient reported depression symptoms
Time frame: From baseline to measurements at 2, 6 and 12 months
Change in patient reported anxiety symptoms
Time frame: From baseline to measurements at 2, 6 and 12 months
Change in patient reported general health status
Time frame: From baseline to measurements at 2, 6 and 12 months
Change in report of sleep medication use
Time frame: From baseline to measurements at 2, 6 and 12 months
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 30 Mar 2026.
- Individual participant dataSharing planned: No. Due to the nature of the study blinding is not possible. Therefore, the data contains privacy sensitive information and only restricted access may be granted for unidentifiable parts of the data. It has yet to be decided which data can be acquired through restricted access.
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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.
Dennis O. Mook-Kanamori principal investigator
Leiden University Medical Center
Rutger A. Middenburg principal investigator
Leiden University Medical Center
Mattijs E. Numans principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and Pro-active identification in people with Insomnia, run by Leiden University Medical Center at 1 site in Netherlands.
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 0 inclusion and 5 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 30 Mar 2026. 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 Netherlands. 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?
Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI) (time frame: From baseline to measurements at 2, 6 and 12 months). 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 30 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.