InsomniaNCT06969040
The Effect of Standard Cognitive-behavioral Therapy+Transcranial Alternating Current on Refractory Insomnia Disorder
A study testing CBTI + tACS in people with Insomnia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The main purpose of this study is to investigate the efficacy of CBTI + transcranial alternating current (TAC) technology in the treatment of refractory insomnia and the mechanism of 'cognitive-behavioural-brain network' interactions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- CBTI + tACS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for insomnia in DSM-5;
- Pittsburgh Sleep Quality Index (PSQI) total score>5 points;
- Age ≥ 18 years old, with a junior high school education or above;
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Individuals with severe physical or mental illnesses are at risk of suicide;
- Clinically diagnosed or suspected sleep breathing disorders, restless leg syndrome, and sleep wake rhythm disorders, as well as workers on rotating shifts;
- Pregnant and lactating women;
- Currently undergoing any psychological therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Hongxing Wang, MD & PhD, +86 13911127385, wanghongxing@xwh.ccmu.edu.cn
About this study
Official title: Evaluation of the Efficacy of Standard Cognitive Behavioural Therapy + Transcranial Alternating Current in the Treatment of Refractory Insomnia Disorder
The main purpose of this study is to investigate the efficacy of CBTI + transcranial alternating current (TAC) technology in the treatment of refractory insomnia and the mechanism of 'cognitive-behavioural-brain network' interactions.
Read the detailed description
Difficult to treat insomnia is a sleep disorder that significantly reduces the quality of sleep for patients, seriously affecting their daily work and study. At present, the main treatment method for refractory insomnia in clinical practice is drug therapy. The problems with drug therapy mainly include easy recurrence after discontinuation and the need for long-term or even lifelong medication. However, tolerance or other adverse reactions limit its long-term use. In recent years, studies have shown that cognitive-behavioral therapy and transcranial alternating current stimulation are effective in treating chronic insomnia, prolonging sleep time and improving sleep quality. However, there have been no reports on the efficacy and safety of CBTI combined with tACS in the treatment of refractory insomnia. Based on the important role of tACS in regulating cortical excitability and spontaneous EEG activity, as well as the precise efficacy of CBTI in improving insomnia, we plan to use CBTI combined with tACS to treat refractory insomnia disorders, in order to improve the effectiveness of treatment. This study adopts a randomized double-blind controlled trial to investigate the efficacy and safety of CBT+tACS in the treatment of refractory insomnia, aiming to provide a basis for clinical data of CBT+tACS in the treatment of refractory insomnia.
- Conditions
- Insomnia
- Being tested
- CBTI + tACS, CBTI + Sham tACS
- Keywords
- Standard Cognitive Behavioural Therapy, tACS, Treatment-Resistant 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.
CBTI + tACSOther
CBTI + tACS group method: CBTI for about 50 minutes each time, for a total of 6 weeks: ① first interview: enrolment assessment; ② second interview: treatment initiation; ③ third interview: sleep titration and sleep hygiene; ④ fourth interview: sleep titration; ⑤ fifth-seventh interview: sleep titration; ⑥ eighth interview: sleep titration (end of standardised CBTI treatment. tACS true stimulation) : Transcranial alternating current therapy (tACS) was operated during the same period of CBTI, with 3 electrodes, placed in the prefrontal lobe and bilateral mastoid; the stimulation intensity was 77.5 Hz, 15 mA, 40 min each time, once a day, 5 days a week, for 6 weeks.
CBTI + Sham tACSOther
CBTI+sham tACS group method: CBTI treatment method was the same as before. tACS pseudo-stimulation: the electrode placement position, stimulation frequency, and time settings were the same as the real stimulation, and the stimulation process only had the output of gradual rising and falling current at the beginning and the last 10s, respectively, so as to make the subjects produce the same subjective feelings as the real stimulation.
| Study group | Role | What they receive |
|---|---|---|
| CBTI+tACS | Experimental | Not described Receives: Other: CBTI + tACS |
| CBTI + Sham tACS | Sham comparator | Not described Receives: Other: CBTI + Sham tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups
Measured: Baseline to week 6
Secondary outcomes (5)
Differences in changes in PSQI scores compared to baseline during follow-up at 3, 6, and 12 months between the two groups
Measured: Baseline to week 6, month 3, month 6, and month 12
Differences in the changes in Beck Depression Inventory (BDI) scores from baseline at the end of treatment and follow-up at 3, 6, and 12 months between the two groups
Measured: Baseline to week 6, month 3, month 6, and month 12
Differences in Beck Anxiety Inventory (BAI) scores between the two groups at the end of treatment, 3 months, 6 months, and 12 months of follow-up compared to baseline.
Measured: Baseline to week 6, month 3, month 6, and month 12
Differences in changes in sleep hygiene awareness and practice scale (SHAPS) between the two groups compared to baseline at the end of treatment, 3 months, 6 months, and 12 months of follow-up [2].
Measured: Baseline to week 6, month 3, month 6, and month 12
Differences in changes in the Insomnia Severity Index (ISI) scores between the two groups at the end of treatment, 3 months, 6 months, and 12 months of follow-up compared to baseline.
Measured: Baseline to week 6, month 3, month 6, and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (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 Xuanwu Hospital, BeijingThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969040
- Sponsor's protocol ID
- CBTI+tACS for TRI
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Standard Cognitive Behavioural Therapy + Transcranial Alternating Current in the Treatment of Refractory Insomnia Disorder
- ClinicalTrials.gov ID
- NCT06969040
- Acronym / sponsor ID
- CBTI+tACS for TRI
- Conditions
- Insomnia
- Keywords
- Standard Cognitive Behavioural Therapy, tACS, Treatment-Resistant Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 13 May 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.
The main purpose of this study is to investigate the efficacy of CBTI + transcranial alternating current (TAC) technology in the treatment of refractory insomnia and the mechanism of 'cognitive-behavioural-brain network' interactions.
Detailed description
Difficult to treat insomnia is a sleep disorder that significantly reduces the quality of sleep for patients, seriously affecting their daily work and study. At present, the main treatment method for refractory insomnia in clinical practice is drug therapy. The problems with drug therapy mainly include easy recurrence after discontinuation and the need for long-term or even lifelong medication. However, tolerance or other adverse reactions limit its long-term use. In recent years, studies have shown that cognitive-behavioral therapy and transcranial alternating current stimulation are effective in treating chronic insomnia, prolonging sleep time and improving sleep quality. However, there have been no reports on the efficacy and safety of CBTI combined with tACS in the treatment of refractory insomnia. Based on the important role of tACS in regulating cortical excitability and spontaneous EEG activity, as well as the precise efficacy of CBTI in improving insomnia, we plan to use CBTI combined with tACS to treat refractory insomnia disorders, in order to improve the effectiveness of treatment. This study adopts a randomized double-blind controlled trial to investigate the efficacy and safety of CBT+tACS in the treatment of refractory insomnia, aiming to provide a basis for clinical data of CBT+tACS in the treatment of refractory insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBTI+tACS | Experimental | Other: CBTI + tACS |
| CBTI + Sham tACS | Sham comparator | Other: CBTI + Sham tACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the diagnostic criteria for insomnia in DSM-5;
- Pittsburgh Sleep Quality Index (PSQI) total score>5 points;
- Age ≥ 18 years old, with a junior high school education or above;
- Voluntarily participate in this study and sign an informed consent form.
Key exclusion criteria (4 listed)
- Individuals with severe physical or mental illnesses are at risk of suicide;
- Clinically diagnosed or suspected sleep breathing disorders, restless leg syndrome, and sleep wake rhythm disorders, as well as workers on rotating shifts;
- Pregnant and lactating women;
- Currently undergoing any psychological therapy.
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 |
|---|---|---|
| CBTI + tACSCBTI + tACS group method: CBTI for about 50 minutes each time, for a total of 6 weeks: ① first interview: enrolment assessment; ② second interview: treatment initiation; ③ third interview: sleep titration and sleep hygiene; ④ fourth interview: sleep titration; ⑤ fifth-seventh interview: sleep titration; ⑥ eighth interview: sleep titration (end of standardised CBTI treatment. tACS true stimulation) : Transcranial alternating current therapy (tACS) was operated during the same period of CBTI, with 3 electrodes, placed in the prefrontal lobe and bilateral mastoid; the stimulation intensity was 77.5 Hz, 15 mA, 40 min each time, once a day, 5 days a week, for 6 weeks. | Other | CBTI+tACS |
| CBTI + Sham tACSCBTI+sham tACS group method: CBTI treatment method was the same as before. tACS pseudo-stimulation: the electrode placement position, stimulation frequency, and time settings were the same as the real stimulation, and the stimulation process only had the output of gradual rising and falling current at the beginning and the last 10s, respectively, so as to make the subjects produce the same subjective feelings as the real stimulation. | Other | CBTI + Sham tACS |
Primary outcome
Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups
Time frame: Baseline to week 6
5 secondary outcomes
Differences in changes in PSQI scores compared to baseline during follow-up at 3, 6, and 12 months between the two groups
Time frame: Baseline to week 6, month 3, month 6, and month 12
Differences in the changes in Beck Depression Inventory (BDI) scores from baseline at the end of treatment and follow-up at 3, 6, and 12 months between the two groups
Time frame: Baseline to week 6, month 3, month 6, and month 12
Differences in Beck Anxiety Inventory (BAI) scores between the two groups at the end of treatment, 3 months, 6 months, and 12 months of follow-up compared to baseline.
Time frame: Baseline to week 6, month 3, month 6, and month 12
Differences in changes in sleep hygiene awareness and practice scale (SHAPS) between the two groups compared to baseline at the end of treatment, 3 months, 6 months, and 12 months of follow-up [2].
Time frame: Baseline to week 6, month 3, month 6, and month 12
Differences in changes in the Insomnia Severity Index (ISI) scores between the two groups at the end of treatment, 3 months, 6 months, and 12 months of follow-up compared to baseline.
Time frame: Baseline to week 6, month 3, month 6, and month 12
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 23 May 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 CBTI + tACS in people with Insomnia, run by Xuanwu Hospital, Beijing 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 4 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 23 May 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. 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?
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 Hongxing Wang, MD & PhD (+86 13911127385, wanghongxing@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups (time frame: Baseline to week 6). 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 23 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.