Carcinoma, Non-Small-Cell LungPhase 2NCT07796438
Low-Frequency rTMS for In-Hospital Sleep Disturbance in Advanced NSCLC
A Phase 2 study testing Active Low-Frequency Repetitive Transcranial Magnetic Stimulation in people with Carcinoma, Non-Small-Cell Lung and Sleep Wake Disorders, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
This randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adults with advanced non-small cell lung cancer (NSCLC) and clinically significant in-hospital sleep disturbance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Sleep Wake Disorders
- What is being tested?
- Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 1 Sep 2028
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years and able to understand the study and provide written informed consent.
- Pathologically or cytologically confirmed non-small cell lung cancer (NSCLC), classified according to the IASLC 9th edition TNM system as unresectable stage IIIB-IIIC, stage IVA-IVB, or recurrent disease after curative-intent treatment and considered by a multidisciplinary team to be unsuitable for further curative local therapy.
- Receiving a stable first-line or later-line systemic anticancer treatment regimen, or receiving inpatient symptom/supportive care after anticancer treatment; the treatment plan must be established before randomization, with no planned initiation of new radiotherapy or change in systemic anticancer therapy before assessment of the primary outcome.
- Mean Richards-Campbell Sleep Questionnaire (RCSQ) score <70 across two consecutive valid inpatient nights and baseline Insomnia Severity Index (ISI) score ≥8.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥3 months.
- Hospitalized for anticancer treatment-related observation, symptom control, or supportive care, with an expected remaining hospital stay of at least 10 days from randomization and ability to complete 10 stimulation sessions and the primary outcome assessment within 14 days.
- Able to complete the prespecified RCSQ assessments and brief sleep diary, continuous Lifesense HR6 monitoring, and 64-channel EEG assessment.
Who cannot join
- Unable to provide valid informed consent, unwilling to participate, or unable to reliably complete the primary RCSQ assessment.
- History of epilepsy or unexplained seizures, active intracranial hemorrhage, significant cerebral edema, elevated intracranial pressure, recent stroke, or severe traumatic brain injury.
- Intracranial ferromagnetic metal, cochlear implant, deep brain stimulator, cardiac pacemaker/implantable cardioverter-defibrillator, or other TMS-incompatible implant.
- Severe scalp infection, open wound, or inability to safely position the TMS coil or EEG cap.
- Pregnancy or any condition considered by the investigator to pose unacceptable risk.
- Active or uncontrolled brain metastases, or brain metastases associated with cerebral edema, hemorrhage, focal neurological symptoms, or a need for escalating corticosteroid treatment.
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- Untreated or unstable obstructive sleep apnea, or another primary sleep disorder requiring priority specialist management.
- Initiation, discontinuation, or ≥50% dose change of sedative-hypnotic medication within 48 hours before randomization, or a planned initiation/discontinuation of medication expected to substantially affect sleep before assessment of the primary outcome.
- Planned initiation of new whole-brain or local radiotherapy, first use of high-dose corticosteroids, or switching of systemic anticancer therapy before assessment of the primary outcome.
- ECOG performance status ≥3, uncontrolled respiratory failure, delirium, or inability to reliably complete the prespecified sleep assessments.
About this study
Official title: Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for In-Hospital Sleep Disturbance in Patients With Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Sham-Controlled Trial
This randomized, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adults with advanced non-small cell lung cancer (NSCLC) and clinically significant in-hospital sleep disturbance.
A total of 160 participants with unresectable stage IIIB-IIIC or stage IV NSCLC, or recurrent NSCLC not suitable for curative local treatment, will be randomly assigned in a 1:1 ratio to active rTMS or matched sham stimulation. Active rTMS will target the left dorsolateral prefrontal cortex and will be delivered once daily for 10 sessions completed within 10-14 days.
The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the nights following stimulation sessions 8, 9, and 10. The study will also evaluate wearable-device sleep measures, insomnia symptoms, pain and symptom burden, psychological symptoms, quality of life, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.
Read the detailed description
This is an investigator-initiated, single-center, prospective, randomized, double-blind, parallel-group, sham-controlled trial in adults with advanced non-small cell lung cancer (NSCLC) and in-hospital sleep disturbance. Eligible participants will have pathologically or cytologically confirmed unresectable stage IIIB-IIIC or stage IVA-IVB NSCLC, or recurrent disease after curative-intent treatment that is considered unsuitable for further curative local therapy. In-hospital sleep disturbance is defined as a mean Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 across two consecutive valid inpatient nights together with a baseline Insomnia Severity Index (ISI) score of at least 8.
Participants will be randomized in a 1:1 ratio to active or sham stimulation. Active treatment will consist of 1-Hz repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex at the F3 position, delivered at 100% of the resting motor threshold with 1,800 pulses per session over approximately 30 minutes. One session will be administered daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive their clinically indicated anticancer treatment and supportive care, and study procedures will not delay or interfere with necessary clinical treatment.
The sham group will undergo matched stimulation using a dedicated sham coil or validated active/sham masking module. Target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures will be matched to active treatment, but the sham procedure will not provide the intended therapeutic cortical stimulation. Participants and outcome assessors will remain blinded to treatment allocation. The stimulation operator cannot be blinded because of device-operation requirements but will not participate in participant recruitment, primary outcome assessment, data entry, or statistical analysis.
The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. RCSQ scores range from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare the active and sham groups using ANCOVA/linear regression adjusted for the mean RCSQ score from two consecutive valid baseline inpatient nights and prespecified randomization stratification factors.
Secondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, other device-derived sleep measures when reliably available, ISI, pain and opioid exposure, lung cancer-related symptom burden, fatigue, anxiety, depressive symptoms, health-related quality of life, functional status, length of hospital stay, anticancer-treatment interruption, treatment feasibility, and adverse events. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in frequency-band power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.
- Being tested
- Active Low-Frequency Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, Advanced Non-Small Cell Lung Cancer, In-Hospital Sleep Disturbance, Dorsolateral Prefrontal Cortex, Richards-Campbell Sleep Questionnaire, 64-Channel Electroencephalography
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Low-Frequency Repetitive Transcranial Magnetic StimulationDevice
Active rTMS will be delivered over the left dorsolateral prefrontal cortex at the F3 position using a figure-of-eight coil. Stimulation parameters are 1 Hz, 100% of the resting motor threshold, and 1,800 pulses per session over approximately 30 minutes. Treatment will be administered once daily for a total of 10 sessions completed within 10-14 days. No more than one study stimulation session will be administered on the same calendar day. Study stimulation will not be performed during intravenous anticancer drug infusion, blood transfusion, sedated bronchoscopy, or clinically significant infusion reactions.
Sham Repetitive Transcranial Magnetic StimulationDevice
Sham stimulation will be administered using a dedicated sham coil or validated active/sham masking module compatible with the study device. Target location, participant positioning, stimulation rhythm, sound, session duration, and interaction procedures will match active rTMS, but the sham procedure will not produce the intended therapeutic cortical stimulation. Sham stimulation will be administered once daily for a total of 10 sessions completed within 10-14 days.
| Study group | Role | What they receive |
|---|---|---|
| Active Low-Frequency rTMS | Experimental | Participants assigned to this arm will receive active low-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex at the F3 position. Stimulation will be delivered at 1 Hz and 100% of the resting motor threshold, with 1,800 pulses per session over approximately 30 minutes, once daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive clinically indicated anticancer treatment, supportive care, and standardized inpatient sleep-support measures. Receives: Device: Active Low-Frequency Repetitive Transcranial Magnetic Stimulation |
| Sham rTMS | Sham comparator | Participants assigned to this arm will receive matched sham rTMS using a dedicated sham coil or validated active/sham masking module. The sham procedure will match the active treatment in target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures, but will not produce the intended therapeutic cortical stimulation. Participants will receive the same clinically indicated anticancer treatment, supportive care, and standardized inpatient sleep-support measures as the active rTMS group. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Richards-Campbell Sleep Questionnaire Total Score Across the Nights Following Stimulation Sessions 8-10
The Richards-Campbell Sleep Questionnaire (RCSQ) total score is calculated as the mean of five visual analog items and ranges from 0 to 100, with higher scores indicating better sleep. The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. At least two valid RCSQ nights are required to calculate the mean. The primary analysis will adjust for the mean RCSQ score from two consecutive valid baseline inpatient nights.
Measured: Mornings after the nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period
Secondary outcomes (6)
Mean Total Sleep Time Measured by Lifesense HR6 Across the Nights Following Stimulation Sessions 8-10
Total sleep time (TST), measured in minutes by the Lifesense HR6 wearable device, will be averaged across valid device nights corresponding to the nights following stimulation sessions 8, 9, and 10. At least two valid device nights are required to calculate the participant-level mean TST.
Measured: Nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period
Generalized Anxiety Disorder-7 Score
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, with total scores ranging from 0 to 21 and higher scores indicating greater symptom severity.
Measured: Baseline and within 24-72 hours after the final stimulation session
Patient Health Questionnaire-9 Score
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), with total scores ranging from 0 to 27 and higher scores indicating greater symptom severity.
Measured: Baseline; within 24-72 hours after the final stimulation session
EORTC QLQ-C30 Global Health Status/Quality of Life Score
Health-related quality of life will be assessed using the authorized Chinese Mandarin (China) version of the EORTC QLQ-C30. The prespecified outcome is the Global Health Status/Quality of Life score, ranging from 0 to 100, with higher scores indicating better overall health-related quality of life.
Measured: Baseline; within 24-72 hours after the final stimulation session;
Proportion of Participants Completing at Least 8 of 10 Stimulation Sessions
Treatment-course completion will be defined as completion of at least 8 of the 10 planned active or sham stimulation sessions.
Measured: During the 10-14-day treatment period
Incidence of Adverse Events and Serious Adverse Events
Adverse events and serious adverse events will be recorded, including headache, scalp discomfort, dizziness, auditory discomfort, syncope, seizure, altered consciousness, new focal neurological deficits, vital-sign abnormalities, and interruptions related to study procedures.
Measured: From the first study-specific procedure through the final prespecified safety follow-up at 12 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start31 Aug 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796438
- Sponsor's protocol ID
- TMS-SLEEP-NSCLC-01
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 1 Sep 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for In-Hospital Sleep Disturbance in Patients With Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07796438
- Acronym / sponsor ID
- TMS-SLEEP-NSCLC-01
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, Advanced Non-Small Cell Lung Cancer, In-Hospital Sleep Disturbance, Dorsolateral Prefrontal Cortex, Richards-Campbell Sleep Questionnaire, 64-Channel Electroencephalography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 1 Sep 2026 (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, double-blind, sham-controlled trial will evaluate whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve in-hospital sleep quality in adults with advanced non-small cell lung cancer (NSCLC) and clinically significant in-hospital sleep disturbance.
A total of 160 participants with unresectable stage IIIB-IIIC or stage IV NSCLC, or recurrent NSCLC not suitable for curative local treatment, will be randomly assigned in a 1:1 ratio to active rTMS or matched sham stimulation. Active rTMS will target the left dorsolateral prefrontal cortex and will be delivered once daily for 10 sessions completed within 10-14 days.
The primary outcome is sleep quality measured using the Richards-Campbell Sleep Questionnaire during the nights following stimulation sessions 8, 9, and 10. The study will also evaluate wearable-device sleep measures, insomnia symptoms, pain and symptom burden, psychological symptoms, quality of life, safety, feasibility, and changes in brain activity measured by 64-channel electroencephalography.
Detailed description
This is an investigator-initiated, single-center, prospective, randomized, double-blind, parallel-group, sham-controlled trial in adults with advanced non-small cell lung cancer (NSCLC) and in-hospital sleep disturbance. Eligible participants will have pathologically or cytologically confirmed unresectable stage IIIB-IIIC or stage IVA-IVB NSCLC, or recurrent disease after curative-intent treatment that is considered unsuitable for further curative local therapy. In-hospital sleep disturbance is defined as a mean Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 across two consecutive valid inpatient nights together with a baseline Insomnia Severity Index (ISI) score of at least 8.
Participants will be randomized in a 1:1 ratio to active or sham stimulation. Active treatment will consist of 1-Hz repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex at the F3 position, delivered at 100% of the resting motor threshold with 1,800 pulses per session over approximately 30 minutes. One session will be administered daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive their clinically indicated anticancer treatment and supportive care, and study procedures will not delay or interfere with necessary clinical treatment.
The sham group will undergo matched stimulation using a dedicated sham coil or validated active/sham masking module. Target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures will be matched to active treatment, but the sham procedure will not provide the intended therapeutic cortical stimulation. Participants and outcome assessors will remain blinded to treatment allocation. The stimulation operator cannot be blinded because of device-operation requirements but will not participate in participant recruitment, primary outcome assessment, data entry, or statistical analysis.
The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. RCSQ scores range from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare the active and sham groups using ANCOVA/linear regression adjusted for the mean RCSQ score from two consecutive valid baseline inpatient nights and prespecified randomization stratification factors.
Secondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, other device-derived sleep measures when reliably available, ISI, pain and opioid exposure, lung cancer-related symptom burden, fatigue, anxiety, depressive symptoms, health-related quality of life, functional status, length of hospital stay, anticancer-treatment interruption, treatment feasibility, and adverse events. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in frequency-band power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Low-Frequency rTMS | Experimental | Device: Active Low-Frequency Repetitive Transcranial Magnetic StimulationParticipants assigned to this arm will receive active low-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex at the F3 position. Stimulation will be delivered at 1 Hz and 100% of the resting motor threshold, with 1,800 pulses per session over approximately 30 minutes, once daily for a total of 10 sessions completed within 10-14 days. Participants will continue to receive clinically indicated anticancer treatment, supportive care, and standardized inpatient sleep-support measures. |
| Sham rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic StimulationParticipants assigned to this arm will receive matched sham rTMS using a dedicated sham coil or validated active/sham masking module. The sham procedure will match the active treatment in target location, participant positioning, stimulation rhythm, sound, session duration, and study interaction procedures, but will not produce the intended therapeutic cortical stimulation. Participants will receive the same clinically indicated anticancer treatment, supportive care, and standardized inpatient sleep-support measures as the active rTMS group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years and able to understand the study and provide written informed consent.
- Pathologically or cytologically confirmed non-small cell lung cancer (NSCLC), classified according to the IASLC 9th edition TNM system as unresectable stage IIIB-IIIC, stage IVA-IVB, or recurrent disease after curative-intent treatment and considered by a multidisciplinary team to be unsuitable for further curative local therapy.
- Receiving a stable first-line or later-line systemic anticancer treatment regimen, or receiving inpatient symptom/supportive care after anticancer treatment; the treatment plan must be established before randomization, with no planned initiation of new radiotherapy or change in systemic anticancer therapy before assessment of the primary outcome.
- Mean Richards-Campbell Sleep Questionnaire (RCSQ) score <70 across two consecutive valid inpatient nights and baseline Insomnia Severity Index (ISI) score ≥8.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥3 months.
Key exclusion criteria (10 listed)
- Unable to provide valid informed consent, unwilling to participate, or unable to reliably complete the primary RCSQ assessment.
- History of epilepsy or unexplained seizures, active intracranial hemorrhage, significant cerebral edema, elevated intracranial pressure, recent stroke, or severe traumatic brain injury.
- Intracranial ferromagnetic metal, cochlear implant, deep brain stimulator, cardiac pacemaker/implantable cardioverter-defibrillator, or other TMS-incompatible implant.
- Severe scalp infection, open wound, or inability to safely position the TMS coil or EEG cap.
- Pregnancy or any condition considered by the investigator to pose unacceptable risk.
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 |
|---|---|---|
| Active Low-Frequency Repetitive Transcranial Magnetic StimulationActive rTMS will be delivered over the left dorsolateral prefrontal cortex at the F3 position using a figure-of-eight coil. Stimulation parameters are 1 Hz, 100% of the resting motor threshold, and 1,800 pulses per session over approximately 30 minutes. Treatment will be administered once daily for a total of 10 sessions completed within 10-14 days. No more than one study stimulation session will be administered on the same calendar day. Study stimulation will not be performed during intravenous anticancer drug infusion, blood transfusion, sedated bronchoscopy, or clinically significant infusion reactions. | Device | Active Low-Frequency rTMS |
| Sham Repetitive Transcranial Magnetic StimulationSham stimulation will be administered using a dedicated sham coil or validated active/sham masking module compatible with the study device. Target location, participant positioning, stimulation rhythm, sound, session duration, and interaction procedures will match active rTMS, but the sham procedure will not produce the intended therapeutic cortical stimulation. Sham stimulation will be administered once daily for a total of 10 sessions completed within 10-14 days. | Device | Sham rTMS |
Primary outcome
Mean Richards-Campbell Sleep Questionnaire Total Score Across the Nights Following Stimulation Sessions 8-10
Time frame: Mornings after the nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period
The Richards-Campbell Sleep Questionnaire (RCSQ) total score is calculated as the mean of five visual analog items and ranges from 0 to 100, with higher scores indicating better sleep. The primary outcome is the participant-level mean RCSQ total score obtained on the mornings after the nights following stimulation sessions 8, 9, and 10. At least two valid RCSQ nights are required to calculate the mean. The primary analysis will adjust for the mean RCSQ score from two consecutive valid baseline inpatient nights.
6 secondary outcomes
Mean Total Sleep Time Measured by Lifesense HR6 Across the Nights Following Stimulation Sessions 8-10
Time frame: Nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period
Generalized Anxiety Disorder-7 Score
Time frame: Baseline and within 24-72 hours after the final stimulation session
Patient Health Questionnaire-9 Score
Time frame: Baseline; within 24-72 hours after the final stimulation session
EORTC QLQ-C30 Global Health Status/Quality of Life Score
Time frame: Baseline; within 24-72 hours after the final stimulation session;
Proportion of Participants Completing at Least 8 of 10 Stimulation Sessions
Time frame: During the 10-14-day treatment period
Incidence of Adverse Events and Serious Adverse Events
Time frame: From the first study-specific procedure through the final prespecified safety follow-up at 12 weeks after hospital discharge
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 1 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Low-Frequency Repetitive Transcranial Magnetic Stimulation in people with Carcinoma, Non-Small-Cell Lung and Sleep Wake Disorders, run by The First Affiliated Hospital of Guangzhou Medical University.
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 10 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Mean Richards-Campbell Sleep Questionnaire Total Score Across the Nights Following Stimulation Sessions 8-10 (time frame: Mornings after the nights following stimulation sessions 8, 9, and 10, within the 10-14-day treatment period). 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 1 Sep 2026.