InsomniaNCT05363995
Feasibility Trial i-Sleep & BioClock Intervention
A study testing i-Sleep & BioClock Intervention in people with Insomnia, run by Leiden University at 1 site in Netherlands.
Trial summary
Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- i-Sleep & BioClock Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2022to 1 Dec 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being fluent in Dutch and/or English
- Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)
- Being ≥ 16 years old
- Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)
Who cannot join
- Current risk for suicidal behaviour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)
Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.
Read the detailed description
The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.
- Conditions
- Insomnia
- Being tested
- i-Sleep & BioClock Intervention
- Keywords
- sleep, biological clock, CBTi, e-health intervention, university students
- 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.
i-Sleep & BioClock InterventionBehavioural
The 'i-Sleep \& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules:
- psychoeducation on insomnia, sleep hygiene and the biological clock,
- stimulus control and sleep restriction therapy,
- worrying and relaxation exercises,
- cognitive therapy to change dysfunctional thoughts about sleep, and
- summary module, relapse prevention, and plan for the future.
The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \& light exposure diary daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Blended e-health intervention Receives: Behavioral: i-Sleep & BioClock Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
Measured: Change from baseline (T0) to 7 weeks after baseline (T1)
Secondary outcomes (6)
Sleep and light exposure diary
This diary includes measures such as sleep efficiency, sleep onset latency, total sleep time, wake after sleep onset, number of awakenings, early morning awakening, time spent outside, screen use before bedtime)
Measured: Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)
Munich Chronotype Questionnaire (MCTQ)
Self-rated scale to assess individual phase of entrainment on work and work-free days, Addresses questions about: bedtime, time spent in bed awake before deciding to turn off the lights, how long it takes to fall asleep, wake up time, get up time on work and work-free days. MCTQ uses the midpoint between sleep on- and offset on free days (mid-sleep on free days, MSF) to assess chronotype
Measured: Change from baseline (T0) to 7 weeks after baseline (T1)
Patient Health Questionnaire (PHQ-9)
9-items self-report instrument for severity of depressive symptoms, scores ranging from 0-27, higher scores indicating more severe depression
Measured: Change from baseline (T0) to 7 weeks after baseline (T1)
Generalised Anxiety Disorder scale (GAD-7)
7-items self-report instrument for severity of anxiety symptoms, scores ranging from 0-21, higher scores indicating more severe anxiety
Measured: Change from baseline (T0) to 7 weeks after baseline (T1)
Work and Social Adjustment Scale (WSAS)
5-item self-report instrument for impairment of functioning, scores ranging from 0-40, higher scores indicating more impairment in functioning
Measured: Change from baseline (T0) to 7 weeks after baseline (T1)
Mental Health Quality of Life questionnaire (MHQoL)
7-item self report instrument for quality of life measure for use in people with mental health problems, scores ranging from 0-21, higher scores indicating higher quality of life, and MHQoL-VAS visual scale ranging from 0 (worst imaginable psychological wellbeing) to 10 (best imaginable psychological wellbeing)
Measured: Change from baseline (T0) to 7 weeks after baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm open feasibility study
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Spinhoven, Leiden University Medical Center
- Investigators
- Niki Antypa, PhD, Principal investigator, Leiden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363995
- Sponsor's protocol ID
- BioClockWP1.4
- Status last verified
- Jul 2023
- First submitted
- 26 Apr 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pape LM, Antypa N, Spinhoven P, van Straten A, Struijs SY; Caring Universities Consortium. Open pilot study of a guided digital self-help intervention targeting sleep and the biological clock in university students using a pre-test post-test design. Sci Rep. 2025 Jul 1;15(1):21837. doi: 10.1038/s41598-025-04891-8.
PubMed 40593043
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of a Blended E-health Intervention for Improving Sleep and the Biological Clock Among University Students (i-Sleep & BioClock)
- ClinicalTrials.gov ID
- NCT05363995
- Acronym / sponsor ID
- BioClockWP1.4
- Conditions
- Insomnia
- Keywords
- sleep, biological clock, CBTi, e-health intervention, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 6 May 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.
Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.
Detailed description
The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm open feasibility study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: i-Sleep & BioClock InterventionBlended e-health intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being fluent in Dutch and/or English
- Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)
- Being ≥ 16 years old
- Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)
Key exclusion criteria (1 listed)
- Current risk for suicidal behaviour
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 |
|---|---|---|
| i-Sleep & BioClock InterventionThe 'i-Sleep \& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules: 1. psychoeducation on insomnia, sleep hygiene and the biological clock, 2. stimulus control and sleep restriction therapy, 3. worrying and relaxation exercises, 4. cognitive therapy to change dysfunctional thoughts about sleep, and 5. summary module, relapse prevention, and plan for the future. The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \& light exposure diary daily. | Behavioural | Experimental |
Primary outcome
Insomnia Severity Index
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity
6 secondary outcomes
Sleep and light exposure diary
Time frame: Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)
Munich Chronotype Questionnaire (MCTQ)
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Patient Health Questionnaire (PHQ-9)
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Generalised Anxiety Disorder scale (GAD-7)
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Work and Social Adjustment Scale (WSAS)
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
Mental Health Quality of Life questionnaire (MHQoL)
Time frame: Change from baseline (T0) to 7 weeks after baseline (T1)
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 2 Aug 2023.
- Derived from this study: PubMed 40593043Pape LM, Antypa N, Spinhoven P, van Straten A, Struijs SY; Caring Universities Consortium. Open pilot study of a guided digital self-help intervention targeting sleep and the biological clock in university students using a pre-test post-test design. Sci Rep. 2025 Jul 1;15(1):21837. doi: 10.1038/s41598-025-04891-8.
- 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.
Niki Antypa, PhD principal investigator
Leiden University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-Sleep & BioClock Intervention in people with Insomnia, run by Leiden University 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 4 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 2 Aug 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. 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 (T0) to 7 weeks after baseline (T1)). 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 NCT05363995, which also lists 1 linked publication.
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 2 Aug 2023.