InsomniaNCT05548907

Sleep Restriction Treatment for Insomnia

A study testing sleep restriction treatment and sleep diary monitoring in people with Insomnia, run by VU University of Amsterdam at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Insomnia
What is being tested?: sleep restriction treatment and sleep diary monitoring
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 148 participants
Where: 1 siteNetherlands
Study dates: 20 Sep 2022to 11 Nov 2023
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

Insomnia Severity Index Score ≥ 10
18 years or older
Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
Daytime problems related to sleep complaints
Sleep efficiency < 85%
Dutch speaking

Who cannot join

(1) No acces to internet
(2) Pregnant or breastfeeding
(3) working in night shifts
(4) currently in psychological treatment (started < 6 months) or on wait-list for treatment
(5) cognitive behavioral treatment for insomnia in last 12 months
(6) concrete suicidal ideation

Show all 9Show fewer

(7) schizophrenic or psychotic disorder
(8) high level of depressive complaints (BDI-II > 28)
(9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University of Amsterdam
Amsterdam, North Holland

Other trials in Netherlands

About this study

Official title: Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial

With a prevalence of about 10% chronic insomnia is a common problem. The standard treatment for insomnia is cognitive behavioral therapy. According to many, the core element within this treatment is sleep restriction. This element has been examined separately in a couple of studies and also appears to be effective in isolation. In the current study the aim is to get more information about the effectiveness of this core element of the treatment. For this reason, a randomized study is conducted to compare sleep restriction with a diary control condition.

The second aim in this study is to determine mechanisms behind treatments. Network intervention analysis will be used to determine which specific symptoms are associated with therapy success. This is the reason that throughout the study weekly and daily measures will be conducted.

The expectations are that:

Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome)
Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)

Conditions: Insomnia
Being tested: sleep restriction treatment, sleep diary monitoring
Keywords: insomnia, behavioral treatment, randomized controlled trial
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.

sleep restriction treatmentBehavioural
Treatment consists of sleep restriction treatment for insomnia. In this treatment, participants limit their bedtimes to the time they actually sleep. If they sleep most of the time in bed again then bedtimes are slowly built up again. This treatment technique has already been studied in several trials and found to be effective.
Mode of delivery is an online booklet, online exercises and weekly telephone support
sleep diary monitoringBehavioural
As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)

Study groups in NCT05548907
Study group	Role	What they receive
Sleep restriction treatment	Experimental	In this condition participants receive a behavioral sleep restriction intervention for six weeks Receives: Behavioral: sleep restriction treatment
Sleep monitoring	Placebo comparator	In this control condition people fill out a sleep diary for six weeks Receives: Behavioral: sleep diary monitoring

What is being measured

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

Insomnia Severity Index
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Measured: Change from baseline to six weeks post-randomization

Secondary outcomes (35)

Sleep diary: sleep onset latency
Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Measured: Change from baseline to six-weeks post-randomization
Sleep diary: sleep onset latency
Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep diary: wake after sleep onset
Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset).
Measured: Change from baseline to six-weeks post-randomization
Sleep diary: wake after sleep onset
Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset )
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep diary: terminal wakefulness
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Measured: Change from baseline to six-weeks post-randomization
Sleep diary: terminal wakefulness
Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep diary: sleep efficiency
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Measured: Change from baseline to six-weeks post-randomization
Sleep diary: sleep efficiency
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep diary: total sleep time
Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Measured: Change from baseline to six-weeks post-randomization
Sleep diary: total sleep time
Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep diary: time in bed
Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Measured: Change from baseline to six-weeks post-randomization
Sleep diary: time in bed
Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Measured: Change from baseline to six-month follow-up (intervention only)
Cognitive arousal
cognitive arousal is measured daily with a visual analogue scale
Measured: Change from baseline to six weeks post randomization
Somatic arousal
Somatic arousal is measured daily with a visual analogue scale
Measured: Change from baseline to six weeks post randomization
Current sleepiness
Sleepiness is measured daily with a visual analogue scale
Measured: Change from baseline to six weeks post randomization
Insomnia Severity
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep safety
Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree \& Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Measured: Change from baseline to six weeks post-randomization
Sleep safety
Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree \& Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Measured: Change from baseline to six-month follow-up (intervention only)
Epworth Sleepiness Scale
To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Measured: Change from baseline to six weeks post-randomization
Epworth Sleepiness Scale
To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Measured: Change from baseline to six-month follow-up (intervention only)
Pre-sleep arousal
Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Measured: Change from baseline to six weeks post-randomization
Pre-sleep arousal
Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Measured: Change from baseline to six-month follow-up (intervention only)
Sleep-bed association
Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Measured: Change from baseline to six weeks post-randomization
Sleep-bed association
Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Measured: Change from baseline to six-month follow-up (intervention only)
Dysfunctional beliefs
Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Measured: Change from baseline to six weeks post-randomization
Dysfunctional beliefs
Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Measured: Change from baseline to six-month follow-up (intervention only)
Depression
Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Measured: Change from baseline to six weeks post-randomization
Depression
Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Measured: Change from baseline to six-month follow-up (intervention only)
Anxiety
Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Measured: Change from baseline to six weeks post-randomization
Anxiety
Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Measured: Change from baseline to six-month follow-up (intervention only)
Acceptance
Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Measured: Change from baseline to six weeks post-randomization
Acceptance
Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Measured: Change from baseline to six-month follow-up (intervention only)
Adverse events
Participants asked to report adverse events ("Did anything unpleasant happen to you that was related to your sleep or participation in the trial?"
Measured: Six-weeks post-randomization
Treatment quality
Treatment quality is rated with a single question 'how do you rate the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction (intervention only)
Measured: Six-weeks post-randomization
Rating coach
Coaches are rated with a single question 'how satisfied were you with your coach during the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction
Measured: Six-weeks post-randomization

Timeline

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

20 Sep 202211 Nov 2023

First posted22 Sep 2022
Study start20 Sep 2022
Primary completion11 Nov 2023
Study completion11 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
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: This is a randomized controlled trial where participants are allocated to either a sleep restriction treatment condition or a sleep monitoring control condition. All participants keep a daily sleep diary and fill out weekly questionnaires
Masking: None (open label)
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05548907
Sponsor's protocol ID: 2022-CP-15342
Status last verified: Dec 2023
First submitted: 6 Sep 2022
Last updated: 22 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be available upon requests

Publications

Klau MM, Lancee J, Looman MI, Van Der Maas HLJ, Visser RM, Blanken TF. From night-to-night and from person-to-person: dynamic phenomena of insomnia. Sleep Adv. 2026 Mar 23;7(2):zpag035. doi: 10.1093/sleepadvances/zpag035. eCollection 2026.
PubMed 42095130
Looman MI, Klau MM, Schoenmakers TM, Kamphuis JH, Blanken TF, Lancee J. The Adherence Conundrum of Sleep Restriction Therapy for Insomnia. J Sleep Res. 2026 Aug;35(4):e70339. doi: 10.1111/jsr.70339. Epub 2026 Apr 1.
PubMed 41918497
Looman MI, Blanken TF, Schoenmakers TM, Reesen JE, Effting M, Linnebank FE, van Straten A, Kamphuis JH, Lancee J. Telephone-Guided Sleep Restriction for Insomnia: A Randomized Sleep Diary-Controlled Trial. Psychother Psychosom. 2025;94(3):147-161. doi: 10.1159/000545138. Epub 2025 Mar 21.
PubMed 40122034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Innovating CBT-I for Cancer Survivors: An Optimization Trial
Cancer Survivorship, Insomnia
Not yet recruiting
AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
Insomnia
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
Insomnia
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain

All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05548907
Acronym / sponsor ID: 2022-CP-15342
Conditions: Insomnia
Keywords: insomnia, behavioral treatment, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: VU University of AmsterdamUniversity, hospital or other
Study start: 20 Sep 2022 (actual)
Primary completion: 11 Nov 2023 (actual)
Study completion: 11 Nov 2023 (actual)
First posted: 22 Sep 2022 (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 expectations are that:

Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome)
Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is a randomized controlled trial where participants are allocated to either a sleep restriction treatment condition or a sleep monitoring control condition. All participants keep a daily sleep diary and fill out weekly questionnaires

Arm	Type	Receives
Sleep restriction treatment	Experimental	Behavioral: sleep restriction treatmentIn this condition participants receive a behavioral sleep restriction intervention for six weeks
Sleep monitoring	Placebo comparator	Behavioral: sleep diary monitoringIn this control condition people fill out a sleep diary for six weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Insomnia Severity Index Score ≥ 10
18 years or older
Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
Daytime problems related to sleep complaints
Sleep efficiency < 85%

Key exclusion criteria (9 listed)

(1) No acces to internet
(2) Pregnant or breastfeeding
(3) working in night shifts
(4) currently in psychological treatment (started < 6 months) or on wait-list for treatment
(5) cognitive behavioral treatment for insomnia in last 12 months

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
sleep restriction treatmentTreatment consists of sleep restriction treatment for insomnia. In this treatment, participants limit their bedtimes to the time they actually sleep. If they sleep most of the time in bed again then bedtimes are slowly built up again. This treatment technique has already been studied in several trials and found to be effective. Mode of delivery is an online booklet, online exercises and weekly telephone support	Behavioural	Sleep restriction treatment
sleep diary monitoringAs an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)	Behavioural	Sleep monitoring

Primary outcome

Insomnia Severity Index
Time frame: Change from baseline to six weeks post-randomization
The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.

35 secondary outcomes

Sleep diary: sleep onset latency
Time frame: Change from baseline to six-weeks post-randomization
Sleep diary: sleep onset latency
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep diary: wake after sleep onset
Time frame: Change from baseline to six-weeks post-randomization
Sleep diary: wake after sleep onset
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep diary: terminal wakefulness
Time frame: Change from baseline to six-weeks post-randomization
Sleep diary: terminal wakefulness
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep diary: sleep efficiency
Time frame: Change from baseline to six-weeks post-randomization
Sleep diary: sleep efficiency
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep diary: total sleep time
Time frame: Change from baseline to six-weeks post-randomization
Sleep diary: total sleep time
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep diary: time in bed
Time frame: Change from baseline to six-weeks post-randomization
Sleep diary: time in bed
Time frame: Change from baseline to six-month follow-up (intervention only)
Cognitive arousal
Time frame: Change from baseline to six weeks post randomization
Somatic arousal
Time frame: Change from baseline to six weeks post randomization
Current sleepiness
Time frame: Change from baseline to six weeks post randomization
Insomnia Severity
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep safety
Time frame: Change from baseline to six weeks post-randomization
Sleep safety
Time frame: Change from baseline to six-month follow-up (intervention only)
Epworth Sleepiness Scale
Time frame: Change from baseline to six weeks post-randomization
Epworth Sleepiness Scale
Time frame: Change from baseline to six-month follow-up (intervention only)
Pre-sleep arousal
Time frame: Change from baseline to six weeks post-randomization
Pre-sleep arousal
Time frame: Change from baseline to six-month follow-up (intervention only)
Sleep-bed association
Time frame: Change from baseline to six weeks post-randomization
Sleep-bed association
Time frame: Change from baseline to six-month follow-up (intervention only)
Dysfunctional beliefs
Time frame: Change from baseline to six weeks post-randomization
Dysfunctional beliefs
Time frame: Change from baseline to six-month follow-up (intervention only)
Depression
Time frame: Change from baseline to six weeks post-randomization
Depression
Time frame: Change from baseline to six-month follow-up (intervention only)
Anxiety
Time frame: Change from baseline to six weeks post-randomization
Anxiety
Time frame: Change from baseline to six-month follow-up (intervention only)
Acceptance
Time frame: Change from baseline to six weeks post-randomization
Acceptance
Time frame: Change from baseline to six-month follow-up (intervention only)
Adverse events
Time frame: Six-weeks post-randomization
Treatment quality
Time frame: Six-weeks post-randomization
Rating coach
Time frame: Six-weeks post-randomization

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 22 Dec 2023.
Derived from this study: PubMed 42095130Klau MM, Lancee J, Looman MI, Van Der Maas HLJ, Visser RM, Blanken TF. From night-to-night and from person-to-person: dynamic phenomena of insomnia. Sleep Adv. 2026 Mar 23;7(2):zpag035. doi: 10.1093/sleepadvances/zpag035. eCollection 2026.
Derived from this study: PubMed 41918497Looman MI, Klau MM, Schoenmakers TM, Kamphuis JH, Blanken TF, Lancee J. The Adherence Conundrum of Sleep Restriction Therapy for Insomnia. J Sleep Res. 2026 Aug;35(4):e70339. doi: 10.1111/jsr.70339. Epub 2026 Apr 1.
Derived from this study: PubMed 40122034Looman MI, Blanken TF, Schoenmakers TM, Reesen JE, Effting M, Linnebank FE, van Straten A, Kamphuis JH, Lancee J. Telephone-Guided Sleep Restriction for Insomnia: A Randomized Sleep Diary-Controlled Trial. Psychother Psychosom. 2025;94(3):147-161. doi: 10.1159/000545138. Epub 2025 Mar 21.
Individual participant dataSharing planned: No. Data will be available upon requests

Related trials for Insomnia

Active, not recruiting
Innovating CBT-I for Cancer Survivors: An Optimization Trial
Cancer Survivorship, Insomnia
Not yet recruiting
AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation
Insomnia
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
Insomnia
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain

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.

Jaap Lancee, PhD principal investigator

University of Amsterdam

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing sleep restriction treatment and sleep diary monitoring in people with Insomnia, run by VU University of Amsterdam 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 6 inclusion and 9 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 22 Dec 2023. 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. Some participants in this study may receive a placebo. 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?

Insomnia Severity Index (time frame: Change from baseline to six weeks post-randomization). 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 NCT05548907, which also lists 3 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 22 Dec 2023.