InsomniaNCT05402761
Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
A study testing Nurse-guided BBTi group and Mobile-delivered BBTi group in people with Insomnia and Traumatic Brain Injury, run by Taipei Medical University at 2 sites in Taiwan.
Trial summary
nsomnia is a frequent complaint reported by patients with TBI, and exacerbates their ability to return to productive activity, which subsequently elevate related healthcare costs and burden. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Traumatic Brain Injury
- What is being tested?
- Nurse-guided BBTi group and Mobile-delivered BBTi group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 Aug 2022to Dec 2026
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have received a diagnosis of TBI at least 3 months before enrollment (TBI in chronic stage),
- yield an initial (i.e., rated in the emergency room) GCS score of 3-15 (mild to severe) and have GCS score of 15 when enrolling into the study,
- report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months,
- have post-TBI insomnia with a total score > 7 on the Chinese version of the insomnia severity scale (CISI) at screening,
- be able to communicate in Mandarin Chinese, and be able to complete cognitive tasks (having Rancho Los Amigos Levels of Cognitive Functioning scale score > 9)
Who cannot join
- include premorbid diagnoses of seizure,
- sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score > 3),
- psychiatric diseases,
- substance abuse,
- alcoholism
- Shift workers and women who are pregnant, breastfeeding, or in the menopausal transition
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Hisao Yean Chiu, PhD, 886227361661 ext. 6329, hychiu0315@tmu.edu.tw
- Recruiting
Skin Kong International Health Center
Taipei, 111
Ta-Wei Wang, Dr, 0954040283, davie71722@gmail.com
About this study
Official title: Effects of Nurse-Guided Brief Behavioral Treatment for Insomnia on Sleep, Mood, and Cognition: Model Establishment and Application in Patients at the Recovery Phase Following Traumatic Brain Injury
nsomnia is a frequent complaint reported by patients with TBI, and exacerbates their ability to return to productive activity, which subsequently elevate related healthcare costs and burden. Existing literatures found that effects of CBTi, first-line therapy for insomnia, on post-traumatic insomnia is still debated, indicating that developing an alternative nonpharmacological therapy for alleviating insomnia following TBI is required. Besides, digital health is one of strategies to achieve precision health. Thus far, knowledge regarding whether mobile-delivered BBTi has non-inferiority effects as BBTi in treating insomnia is still lacking. Therefore, a RCT with a large sample size to examine the immediate and lasting effects of BBTi and mobile-delivered BBTi on insomnia, mood disturbances, and cognitive dysfunctions in patients following TBI at the recovery stage compared with the control participants.
Read the detailed description
Background: Insomnia is highly prevalent in adults with traumatic brain injury (TBI), which in turn undermine their mood, cognitive functions, and quality of life. However, an effective non-pharmacological intervention for managing insomnia in this population is still lacking. Nurses, the first-line healthcare providers, should therefore seek an approach for managing post-TBI sleep. Brief behavioral treatment for insomnia (BBTi) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been applied in people with neurological deficits such as TBI.
Purposes: To establish the BBTi treatment model among insomniacs in Taiwan, and to examine the immediate and lasting effects of nurse-guided BBTi and mobile-delivered BBTi on sleep, mood, and cognitive functions in adults with TBI. We hypothesize that people with TBI undergoing nurse-guided BBTi and mobile-delivered BBTi will experience greater alleviations in insomnia, mood disturbances, and cognitive dysfunctions in comparison with participants in the sleep hygiene control group.
Methods: This 3-year, assessor-blinded randomized controlled trial will employ a three-arm parallel-group design. A total of 228 TBI survivors with insomnia complaints will be randomly allocated to the nurse-guided BBTi, mobile-delivered BBTi, or sleep hygiene control group in a 1:1:1 ratio. For the nurse-guided BBTi group, all participants will experience 4-week-long BBTi via 2 in person and 2 telephone sessions. For the mobile-delivered BBTi, participants will use the apps in conjunction with the standard BBTi procedures provided by the functions of apps: "Sleep Aids" and "Relaxation therapy". For the sleep hygiene control group, they will receive usual care and sleep hygiene education. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Epworth sleepiness scale, Chinese version of Pittsburgh sleep quality index, and 7-day actigraphy with a sleep diary. Secondary outcomes consist of mood and cognitive functions assessed using The Depression, Anxiety and Stress Scale - 21 Items, Ruff 2 \& 7 test, Rey Auditory Verbal Learning Test, and Symbol Digit Modalities Test.
Questionnaires and actigraphy will be assessed in pretreatment, posttreatment, and the 6th and 12th months after treatment. A generalized estimating equation will be used to test research hypotheses.
- Conditions
- Insomnia, Traumatic Brain Injury
- Being tested
- Nurse-guided BBTi group, Mobile-delivered BBTi group
- Keywords
- Insominia, BBTi, Traumatic Brain Injury
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-guided BBTi groupBehavioural
On the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi. In the end of week 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges.
Mobile-delivered BBTi groupBehavioural
They will use the app in conjunction with the standard BBTi procedures provided by the app, such as stimulus control, sleep restriction and audio-guided relaxation techniques (suggest to use before bedtime).
| Study group | Role | What they receive |
|---|---|---|
| Nurse-guided BBTi group | Experimental | Participants will experience 4-week treatment period (2 in person and 2 via telephone). Receives: Behavioral: Nurse-guided BBTi group |
| Mobile-delivered BBTi group | Experimental | Participants will be shown how to download and use the app in their own mobile device after the baseline assessment. Receives: Behavioral: Mobile-delivered BBTi group |
| Sleep hygiene control group | No intervention | Participants will receive sleep hygiene at the enrollment of the study and be required to maintain their usual lifestyle and medical treatment for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insomnia Severity
The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of > 7 is used to diagnose subthreshold insomnia.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Sleep quality
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Daytime Sleepiness
Daytime Sleepiness will be measured by Epworth Sleepiness Scale (ESS). ESS has 8 questions to evaluate the condition of dozing off or falling asleep. The score range from 0-24, if score>10 is associated with daytime sleepiness.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Secondary outcomes (6)
Changes in Depression
Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Anxiety
Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Stress
Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Ruff 2 and 7
The Ruff 2 \& 7 test will be used to test sustained and selective aspects of visual attention. It consists of 20 trials (10 Automatic Detection trials and 10 Controlled Search trials), with three line per trial, administered consecutively in 15-s intervals, working from left to right. The Automatic Detection and Controlled Search scores will used to assess selective attention. Sustained attention is measured primarily by the Total Speed (number of correctly identified targets during the allotted 5-min duration), and Total Accuracy (number of targets identified during the 5-min duration divided by the number of possible targets) scores.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT is a measure of verbal memory in which a subject is read a list of 15 words and asked to recall them after the examiner finishes reading the list. The subjects are exposed to the second list once, after which they must recall as many words as they can from the first list. After a 30-minute delay, the subjects are again asked to recall the words from the first list; they subsequently participate in a recognition trial in which they determine whether the word heard was in the first list.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Symbol digital modalities
The SDMT is a brief test of information processing speed that has become the most commonly used cognitive measure in patients with TBI. It consists of a sheet of paper with a sequence of nine symbols and nine corresponding numbers at the top. Responses can be written or oral, and for either response mode, the administration time is 5 min. A higher score indicates a more favorable performance.
Measured: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start15 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Yean Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402761
- Sponsor's protocol ID
- N202104039
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nurse-Guided Brief Behavioral Treatment for Insomnia on Sleep, Mood, and Cognition: Model Establishment and Application in Patients at the Recovery Phase Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05402761
- Acronym / sponsor ID
- N202104039
- Conditions
- Insomnia, Traumatic Brain Injury
- Keywords
- Insominia, BBTi, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Jun 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.
nsomnia is a frequent complaint reported by patients with TBI, and exacerbates their ability to return to productive activity, which subsequently elevate related healthcare costs and burden. Existing literatures found that effects of CBTi, first-line therapy for insomnia, on post-traumatic insomnia is still debated, indicating that developing an alternative nonpharmacological therapy for alleviating insomnia following TBI is required. Besides, digital health is one of strategies to achieve precision health. Thus far, knowledge regarding whether mobile-delivered BBTi has non-inferiority effects as BBTi in treating insomnia is still lacking. Therefore, a RCT with a large sample size to examine the immediate and lasting effects of BBTi and mobile-delivered BBTi on insomnia, mood disturbances, and cognitive dysfunctions in patients following TBI at the recovery stage compared with the control participants.
Detailed description
Background: Insomnia is highly prevalent in adults with traumatic brain injury (TBI), which in turn undermine their mood, cognitive functions, and quality of life. However, an effective non-pharmacological intervention for managing insomnia in this population is still lacking. Nurses, the first-line healthcare providers, should therefore seek an approach for managing post-TBI sleep. Brief behavioral treatment for insomnia (BBTi) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been applied in people with neurological deficits such as TBI.
Purposes: To establish the BBTi treatment model among insomniacs in Taiwan, and to examine the immediate and lasting effects of nurse-guided BBTi and mobile-delivered BBTi on sleep, mood, and cognitive functions in adults with TBI. We hypothesize that people with TBI undergoing nurse-guided BBTi and mobile-delivered BBTi will experience greater alleviations in insomnia, mood disturbances, and cognitive dysfunctions in comparison with participants in the sleep hygiene control group.
Methods: This 3-year, assessor-blinded randomized controlled trial will employ a three-arm parallel-group design. A total of 228 TBI survivors with insomnia complaints will be randomly allocated to the nurse-guided BBTi, mobile-delivered BBTi, or sleep hygiene control group in a 1:1:1 ratio. For the nurse-guided BBTi group, all participants will experience 4-week-long BBTi via 2 in person and 2 telephone sessions. For the mobile-delivered BBTi, participants will use the apps in conjunction with the standard BBTi procedures provided by the functions of apps: "Sleep Aids" and "Relaxation therapy". For the sleep hygiene control group, they will receive usual care and sleep hygiene education. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Epworth sleepiness scale, Chinese version of Pittsburgh sleep quality index, and 7-day actigraphy with a sleep diary. Secondary outcomes consist of mood and cognitive functions assessed using The Depression, Anxiety and Stress Scale - 21 Items, Ruff 2 \& 7 test, Rey Auditory Verbal Learning Test, and Symbol Digit Modalities Test.
Questionnaires and actigraphy will be assessed in pretreatment, posttreatment, and the 6th and 12th months after treatment. A generalized estimating equation will be used to test research hypotheses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nurse-guided BBTi group | Experimental | Behavioral: Nurse-guided BBTi groupParticipants will experience 4-week treatment period (2 in person and 2 via telephone). |
| Mobile-delivered BBTi group | Experimental | Behavioral: Mobile-delivered BBTi groupParticipants will be shown how to download and use the app in their own mobile device after the baseline assessment. |
| Sleep hygiene control group | No intervention | –Participants will receive sleep hygiene at the enrollment of the study and be required to maintain their usual lifestyle and medical treatment for 4 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have received a diagnosis of TBI at least 3 months before enrollment (TBI in chronic stage),
- yield an initial (i.e., rated in the emergency room) GCS score of 3-15 (mild to severe) and have GCS score of 15 when enrolling into the study,
- report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months,
- have post-TBI insomnia with a total score > 7 on the Chinese version of the insomnia severity scale (CISI) at screening,
- be able to communicate in Mandarin Chinese, and be able to complete cognitive tasks (having Rancho Los Amigos Levels of Cognitive Functioning scale score > 9)
Key exclusion criteria (6 listed)
- include premorbid diagnoses of seizure,
- sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score > 3),
- psychiatric diseases,
- substance abuse,
- alcoholism
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 |
|---|---|---|
| Nurse-guided BBTi groupOn the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi. In the end of week 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges. | Behavioural | Nurse-guided BBTi group |
| Mobile-delivered BBTi groupThey will use the app in conjunction with the standard BBTi procedures provided by the app, such as stimulus control, sleep restriction and audio-guided relaxation techniques (suggest to use before bedtime). | Behavioural | Mobile-delivered BBTi group |
Primary outcome
Changes in Insomnia Severity
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
The ISI consists of seven items, and each item can be rated from 0 to 4, resulting in total score ranging from 0 to 28, with higher scores indicating greater insomnia severity. A cutoff score of > 7 is used to diagnose subthreshold insomnia.
Changes in Sleep quality
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
Changes in Daytime Sleepiness
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Daytime Sleepiness will be measured by Epworth Sleepiness Scale (ESS). ESS has 8 questions to evaluate the condition of dozing off or falling asleep. The score range from 0-24, if score>10 is associated with daytime sleepiness.
Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.
Changes in Sleep parameters from sleep logs: total sleep time(TST)
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.
6 secondary outcomes
Changes in Depression
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Anxiety
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Stress
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Ruff 2 and 7
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Rey Auditory Verbal Learning Test (RAVLT)
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
Changes in Symbol digital modalities
Time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished
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 31 Mar 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-guided BBTi group and Mobile-delivered BBTi group in people with Insomnia and Traumatic Brain Injury, run by Taipei Medical University at 2 sites 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 5 inclusion and 6 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 31 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 2 sites 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 Hsiao-Yean Chiu, Ass. Professor (886-2-27361661 ext. 6329, hychiu0315@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Insomnia Severity (time frame: at baseline and the 5th week and the 12th week after intervention finished and the 24th week after intervention finished). The study lists 7 primary outcomes in all. 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 31 Mar 2026.