Chronic InsomniaNCT06481423
Digital Management of Sleep Health
A study testing dCBT-I and Relaxing music in people with Chronic Insomnia, run by Jia Xiu at 1 site in China.
Trial summary
The goal of this clinical trial is to explore whether cognitive behavioral intervention for insomnia(CBT-I) realized through audio, video, and articles on smartphone apps("ForSleep" developed by the investigators) can improve the sleep quality of insomnia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- dCBT-I and Relaxing music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- Insomnia Severity Index Scale (ISI) score of 8~21
- Proficient in the use of smartphones
- Chinese native speaker
Who cannot join
- Those with other combined sleep problems, such as apnoea syndrome, restless leg syndrome, etc.
- Women during pregnancy
- risky jobs that require high concentration, such as working at heights, long-distance driving, etc.
- previous or current diagnosis of severe neurological disorders such as epilepsy
- previous or current diagnosis of mental illness such as depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, etc.
- history of drug or alcohol abuse
- a significant negative risk of suicide
- serious physical illness (e.g., cardiovascular, hepatic, renal, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University
Shanghai, Shanghai Municipality, 200433
About this study
The goal of this clinical trial is to explore whether cognitive behavioral intervention for insomnia(CBT-I) realized through audio, video, and articles on smartphone apps("ForSleep" developed by the investigators) can improve the sleep quality of insomnia patients. The main question it aims to answer is:
Does CBT-I delivered via smartphone apps improve sleep quality evaluated by scales in patients with insomnia?
Read more
Investigators will compare the treatment group receiving the CBT-I intervention via smartphone apps to a control group receiving relaxation training to see if there are significant improvements in sleep quality.
Participants will be asked to:
Use an app("ForSleep") designed for CBT-I to follow a structured therapy program.
Complete daily sleep diaries and periodic scales to track their sleep quality.
Read the detailed description
All participants sign the informed consent form online. The study is an online, single-blind, parallel-group, superiority randomized experiment of digital CBT-I(dCBT-I). The randomization is performed using stratified random sampling to ensure non-significant differences in age, gender, and basic sleep quality between the two groups. The screening, informed consent, assessments, allocation to conditions, delivery of the interventions, scale evaluations, and follow-ups are all carried out online. WeChat chatting groups for daily notification and communication are set up respectively. The experiment lasts 5 (and more) weeks included 3 weeks of intervention and 2 weeks of follow-up.
All participants are required to keep sleep diaries. They self-evaluate via Insomnia Severity Index (ISI), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Hygiene Index (SHI), and Epworth Sleepiness Scale (ESS) to assess insomnia severity, sleep-related cognition, and behaviors at 5 time points. The first 3 times are at the first day, after 7 days and 14 days, before starting each new session. After 3-week program, the above scales are retaken during days 22~25 and days 36~39 as follow-ups. The evaluating time is different on account of individual rate of progress to accomplish the 3-week program.
Digital cognitive behavioral therapy is delivered using an app developed by Fudan University. Digital intervention is structured into 3 sessions with a 7-days course in each session. The intervention group undertook 3 weeks of tasks which consisted of cognitive, behavioral, and relaxation parts of CBT-I and typically lasted 15 minutes per day. Two pieces of relaxing music are recommended daily to the control group instead of the standard relaxation practice. All participants have access to 30 relaxing music and articles on sleep hygiene that are made available in the app.
- Conditions
- Chronic Insomnia
- Being tested
- dCBT-I, Relaxing music
- Keywords
- Digital cognitive behavior therapy for insomnia, Chronic Insomnia
- 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.
dCBT-IBehavioural
A digital cognitive behavioral intervention course that addresses multiple aspects such as basic sleep knowledge, sleep hygiene, sleep behaviors, improving negative cognition, and improving emotions. The intervention is delivered through video, audio, and text formats.
Relaxing musicBehavioural
Participants can freely listen relaxing music
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app Receives: Behavioral: dCBT-I; Behavioral: Relaxing music |
| Control Group | Other | Participants can only freely access relaxing music in the app. They don't have access to dCBT-I Receives: Behavioral: Relaxing music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index Scale(PSQI)
A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome
Measured: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Secondary outcomes (4)
Dysfunctional Beliefs and Attitudes about Sleep Scale(DBAS)
A scale that evaluates the sleep attitude, the scale scores range from 0 to 64, and lower scores mean a better outcome
Measured: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Sleep Hygiene Index Scale(SHI)
A scale that evaluates sleep hygiene, the scale scores range from 0 to 52, and lower scores mean a better outcome
Measured: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
The Insomnia Severity Index Scale(ISI)
A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome
Measured: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Epworth Sleepiness Scale(ESS)
A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome
Measured: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 May 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jia Xiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia Xiu, Fudan University
- Investigators
- Shouyan Wang, PhD, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481423
- Sponsor's protocol ID
- FE22197I
- Status last verified
- May 2025
- First submitted
- 20 Jun 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to concerns regarding patient confidentiality and privacy, the investigators are unable to share the data from our study. The sensitive nature of the data includes personal health information that could potentially identify individual participants. Despite our best efforts to anonymize the data, the risk of re-identification remains. Additionally, the investigators are bound by ethical guidelines and institutional policies that require us to protect the privacy of our participants and maintain the confidentiality of their information. As such, the investigators must restrict access to the data to ensure compliance with these ethical and legal standards.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Management of Sleep Health
- ClinicalTrials.gov ID
- NCT06481423
- Acronym / sponsor ID
- FE22197I
- Conditions
- Chronic Insomnia
- Keywords
- Digital cognitive behavior therapy for insomnia, Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Jia XiuUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 1 Jul 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 explore whether cognitive behavioral intervention for insomnia(CBT-I) realized through audio, video, and articles on smartphone apps("ForSleep" developed by the investigators) can improve the sleep quality of insomnia patients. The main question it aims to answer is:
Does CBT-I delivered via smartphone apps improve sleep quality evaluated by scales in patients with insomnia?
Investigators will compare the treatment group receiving the CBT-I intervention via smartphone apps to a control group receiving relaxation training to see if there are significant improvements in sleep quality.
Participants will be asked to:
Use an app("ForSleep") designed for CBT-I to follow a structured therapy program.
Complete daily sleep diaries and periodic scales to track their sleep quality.
Detailed description
All participants sign the informed consent form online. The study is an online, single-blind, parallel-group, superiority randomized experiment of digital CBT-I(dCBT-I). The randomization is performed using stratified random sampling to ensure non-significant differences in age, gender, and basic sleep quality between the two groups. The screening, informed consent, assessments, allocation to conditions, delivery of the interventions, scale evaluations, and follow-ups are all carried out online. WeChat chatting groups for daily notification and communication are set up respectively. The experiment lasts 5 (and more) weeks included 3 weeks of intervention and 2 weeks of follow-up.
All participants are required to keep sleep diaries. They self-evaluate via Insomnia Severity Index (ISI), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Sleep Hygiene Index (SHI), and Epworth Sleepiness Scale (ESS) to assess insomnia severity, sleep-related cognition, and behaviors at 5 time points. The first 3 times are at the first day, after 7 days and 14 days, before starting each new session. After 3-week program, the above scales are retaken during days 22~25 and days 36~39 as follow-ups. The evaluating time is different on account of individual rate of progress to accomplish the 3-week program.
Digital cognitive behavioral therapy is delivered using an app developed by Fudan University. Digital intervention is structured into 3 sessions with a 7-days course in each session. The intervention group undertook 3 weeks of tasks which consisted of cognitive, behavioral, and relaxation parts of CBT-I and typically lasted 15 minutes per day. Two pieces of relaxing music are recommended daily to the control group instead of the standard relaxation practice. All participants have access to 30 relaxing music and articles on sleep hygiene that are made available in the app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: dCBT-I, Behavioral: Relaxing musicParticipants receive digital cognitive behavioral intervention for insomnia(dCBT-I) via their smartphone, and can freely access relaxing music in the app |
| Control Group | Other | Behavioral: Relaxing musicParticipants can only freely access relaxing music in the app. They don't have access to dCBT-I |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years old
- Insomnia Severity Index Scale (ISI) score of 8~21
- Proficient in the use of smartphones
- Chinese native speaker
Key exclusion criteria (8 listed)
- Those with other combined sleep problems, such as apnoea syndrome, restless leg syndrome, etc.
- Women during pregnancy
- risky jobs that require high concentration, such as working at heights, long-distance driving, etc.
- previous or current diagnosis of severe neurological disorders such as epilepsy
- previous or current diagnosis of mental illness such as depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, etc.
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 |
|---|---|---|
| dCBT-IA digital cognitive behavioral intervention course that addresses multiple aspects such as basic sleep knowledge, sleep hygiene, sleep behaviors, improving negative cognition, and improving emotions. The intervention is delivered through video, audio, and text formats. | Behavioural | Intervention Group |
| Relaxing musicParticipants can freely listen relaxing music | Behavioural | Control Group, Intervention Group |
Primary outcome
Pittsburgh Sleep Quality Index Scale(PSQI)
Time frame: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome
4 secondary outcomes
Dysfunctional Beliefs and Attitudes about Sleep Scale(DBAS)
Time frame: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Sleep Hygiene Index Scale(SHI)
Time frame: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
The Insomnia Severity Index Scale(ISI)
Time frame: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
Epworth Sleepiness Scale(ESS)
Time frame: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)
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 4 Jun 2025.
- Individual participant dataSharing planned: No. Due to concerns regarding patient confidentiality and privacy, the investigators are unable to share the data from our study. The sensitive nature of the data includes personal health information that could potentially identify individual participants. Despite our best efforts to anonymize the data, the risk of re-identification remains. Additionally, the investigators are bound by ethical guidelines and institutional policies that require us to protect the privacy of our participants and maintain the confidentiality of their information. As such, the investigators must restrict access to the data to ensure compliance with these ethical and legal standards.
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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.
Shouyan Wang, PhD study chair
Fudan 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 dCBT-I and Relaxing music in people with Chronic Insomnia, run by Jia Xiu at 1 site in China.
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 8 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 4 Jun 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 China. 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?
Pittsburgh Sleep Quality Index Scale(PSQI) (time frame: baseline(before the intervention); intervention stage(every week during 3-week intervention); follow-up stage(every week during 2-week follow-up)). 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 4 Jun 2025.