InsomniaDSP-CSNCT06853106
Digital Sleep Program for College Students with Insomnia
A study testing digital-based multimodal sleep management program in people with Insomnia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress… Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- digital-based multimodal sleep management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Apr 2024to 31 Jul 2027
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Registered as a full-time student
- Aged 18 to 26 years old
- Experiencing insomnia for at least three months
- Currently own and use a personal mobile device
- Ability to read and speak Chinese
- Not taking hypnotics, sedatives, or antidepressants
- Not pregnant or lactating
Who cannot join
- Using a smartphone model that cannot support the app
- Currently using other sleep program apps
- Meeting a STOP-BANG score of ≥3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medicine University
Taipei, 11031
Pei-Shan Tsai, PhD, +886227361661 ext. 6321, ptsai@tmu.edu.tw
About this study
Official title: Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial
This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.
Read the detailed description
This is a parallel-group, randomized controlled trial (RCT). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled.
Eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (N = 45) and a waitlist control group (N = 45).
The primary outcome is insomnia severity, assessed using the Insomnia Severity Index (ISI). The secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the Epworth Sleepiness Scale (ESS), a wearable sleep tracker, the Ford Insomnia Response to Stress Test (FIRST), the Brief Resilience Scale (BRS), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Index II (BDI-II), respectively. Additionally, chronotype will be assessed using the Morningness-Eveningness Questionnaire (MEQ) as a moderating role to be tested in this study. All outcomes will be measured at three time points: T0 (baseline assessment), T1 (immediately after the 4-week intervention period), and T2 (4 weeks after the intervention period).
- Conditions
- Insomnia
- Being tested
- Waitlist control group, digital-based multimodal sleep management program
- Keywords
- Anxiety, Chronotypes, Daytime Sleepiness, Depression, Digital-based Sleep Management, Insomnia, Resilience, Sleep Reactivity, Mindfulness-based Breathing
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Disorders of Excessive Somnolence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waitlist control groupOther
The participants in the waitlist control group will be informed that they are on a waiting list during the intervention period, serving as a no-treatment control. They will receive the sleep intervention (i.e., the digital-based sleep management program) four weeks after the intervention period is completed.
digital-based multimodal sleep management programBehavioural
The digital-based multimodal sleep management program consists of (1) sleep hygiene education, (2) sleep restriction, and (3) mindfulness breathing exercises. The program is internet-integrated and delivered via Google Meet, with 45-minute weekly sessions over four weeks. To increase participants' adherence to the sleep management program , the course instructor will request the participants to record their daily sleep diaries (time to bed, time to sleep, wake time during sleep and wake time) and sleep journals(practices of sleep hygiene, sleep restriction and mindfulness breathing exercise) in the mobile app for at least five consecutive days each week.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control group | Other | Participants in the waitlist control group will maintain their daily routines without receiving any intervention throughout the experiment. Receives: Other: Waitlist control group |
| digital-based multimodal sleep management program | Experimental | Participants in the experimental group will receive a 4-week digital-based multimodal sleep management program. Receives: Behavioral: digital-based multimodal sleep management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity:The Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) consists of seven items that assess the current perception of the severity of three insomnia symptoms. Each item is rated on a 5-point Likert scale, with the total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia.
Measured: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.
Secondary outcomes (6)
Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is a self-reported measure of daytime sleepiness, assessing the propensity to doze or fall asleep during eight common daily activities. Each situation is rated on a 4-point scale, ranging from 0 ("would never doze") to 3 ("high chance of dozing"). The total score, obtained by summing the scores of the eight items, ranges from 0 to 24, with higher scores indicating greater levels of daytime sleepiness.
Measured: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.
Sleep Parameters
The sleep parameters will be recorded using a wearable sleep tracker (oCare Wrist-Worn Pro 100, Taiwan Biophotonic Corporation, Taiwan) daily for five consecutive days both before and immediately after the intervention. The wearable device will be paired with a mobile app for data collection and analysis. The sleep parameters derived from the device include sleep onset latency (SOL), wake after sleep onset (WASO), time in bed (TIB), total sleep time (TST), and sleep efficiency (SE).
Measured: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Sleep Reactivity: The Chinese version of the Ford Insomnia Response to Stress Test (FIRST)
The Ford Insomnia Response to Stress Test (FIRST) measures the extent to which sleep is affected by stress in individuals experiencing stressful conditions. It is a self-administered questionnaire consisting of nine questions, each rated on a 4-point scale, ranging from 1 (unlikely to happen) to 4 (very likely to happen). The total score ranges from 9 to 36, with higher scores indicating a greater degree of sleep disruption due to stress.
Measured: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Resilience: The Chinese version of the Brief Resilience Scale (BRS)
The Brief Resilience Scale (BRS) consists of six questions, each rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree). Questions 1, 3, and 5 are forward-scored, while questions 2, 4, and 6 are reverse-scored. The total score ranges from 5 to 25, with higher scores indicating greater resilience, reflecting an individual's ability to adapt and recover from adverse events.
Measured: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Depression: The Beck Depression Index II (BDI II)
The Beck Depression Inventory-II (BDI-II) is a 21-item questionnaire designed to assess depressive symptoms. Response options range from 0 (did not feel it) to 3 (most or almost all the time). The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Measured: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Anxiety: The State Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a self-report scale used to assess anxiety symptoms. It consists of 40 items, divided into two distinct dimensions: trait anxiety (20 items) and state anxiety (20 items). Each item is rated on a 4-point Likert scale, ranging from "almost never" to "almost always", with higher scores indicating greater levels of anxiety.
Measured: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start24 Apr 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Pei-Shan, Tsai, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853106
- Sponsor's protocol ID
- N202401041
- Acronym
- DSP-CS
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital-Based Multimodal Sleep Management Program for College Students with Insomnia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06853106
- Acronym / sponsor ID
- DSP-CS / N202401041
- Conditions
- Insomnia
- Keywords
- Anxiety, Chronotypes, Daytime Sleepiness, Depression, Digital-based Sleep Management, Insomnia, Resilience, Sleep Reactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. Additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.
Detailed description
This is a parallel-group, randomized controlled trial (RCT). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled.
Eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (N = 45) and a waitlist control group (N = 45).
The primary outcome is insomnia severity, assessed using the Insomnia Severity Index (ISI). The secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the Epworth Sleepiness Scale (ESS), a wearable sleep tracker, the Ford Insomnia Response to Stress Test (FIRST), the Brief Resilience Scale (BRS), the State-Trait Anxiety Inventory (STAI), and the Beck Depression Index II (BDI-II), respectively. Additionally, chronotype will be assessed using the Morningness-Eveningness Questionnaire (MEQ) as a moderating role to be tested in this study. All outcomes will be measured at three time points: T0 (baseline assessment), T1 (immediately after the 4-week intervention period), and T2 (4 weeks after the intervention period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control group | Other | Other: Waitlist control groupParticipants in the waitlist control group will maintain their daily routines without receiving any intervention throughout the experiment. |
| digital-based multimodal sleep management program | Experimental | Behavioral: digital-based multimodal sleep management programParticipants in the experimental group will receive a 4-week digital-based multimodal sleep management program. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Registered as a full-time student
- Aged 18 to 26 years old
- Experiencing insomnia for at least three months
- Currently own and use a personal mobile device
- Ability to read and speak Chinese
Key exclusion criteria (3 listed)
- Using a smartphone model that cannot support the app
- Currently using other sleep program apps
- Meeting a STOP-BANG score of ≥3
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 |
|---|---|---|
| Waitlist control groupThe participants in the waitlist control group will be informed that they are on a waiting list during the intervention period, serving as a no-treatment control. They will receive the sleep intervention (i.e., the digital-based sleep management program) four weeks after the intervention period is completed. | Other | Waitlist control group |
| digital-based multimodal sleep management programThe digital-based multimodal sleep management program consists of (1) sleep hygiene education, (2) sleep restriction, and (3) mindfulness breathing exercises. The program is internet-integrated and delivered via Google Meet, with 45-minute weekly sessions over four weeks. To increase participants' adherence to the sleep management program , the course instructor will request the participants to record their daily sleep diaries (time to bed, time to sleep, wake time during sleep and wake time) and sleep journals(practices of sleep hygiene, sleep restriction and mindfulness breathing exercise) in the mobile app for at least five consecutive days each week. | Behavioural | digital-based multimodal sleep management program |
Primary outcome
Insomnia Severity:The Insomnia Severity Index (ISI)
Time frame: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.
The Insomnia Severity Index (ISI) consists of seven items that assess the current perception of the severity of three insomnia symptoms. Each item is rated on a 5-point Likert scale, with the total score ranging from 0 to 28. Higher scores indicate greater severity of insomnia.
6 secondary outcomes
Daytime Sleepiness:The Epworth Sleepiness Scale (ESS)
Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention.
Sleep Parameters
Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Sleep Reactivity: The Chinese version of the Ford Insomnia Response to Stress Test (FIRST)
Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Resilience: The Chinese version of the Brief Resilience Scale (BRS)
Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Depression: The Beck Depression Index II (BDI II)
Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Anxiety: The State Trait Anxiety Inventory (STAI)
Time frame: T0 = baseline; T1 = immediately after sleep intervention; T2 = 4 weeks after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital-based multimodal sleep management program in people with Insomnia, run by Taipei Medical University at 1 site in Taiwan.
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 7 inclusion and 3 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 28 Feb 2025. 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 Taiwan. 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 Pei-Shan Tsai, PhD (+886227361661 ext. 6321, ptsai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity:The Insomnia Severity Index (ISI) (time frame: T0 = baseline; T1 = immediately after intervention; T2 = 4 weeks after intervention.). 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 28 Feb 2025.