Sleep Wake DisordersPhase 2TMS-SLEEP-LTxNCT07796425
Low-Frequency rTMS for In-Hospital Sleep Disturbance After Lung Transplantation
A Phase 2 study testing Active Low-Frequency Repetitive Transcranial Magnetic Stimulation in people with Sleep Wake Disorders and Lung Transplantation, 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 adult lung transplant recipients during early postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Wake Disorders, Lung Transplantation
- What is being tested?
- Active Low-Frequency Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2026to 31 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years and able to provide independent written informed consent. First single- or double-lung transplantation. Postoperative day 7-21 at randomization; extubated for at least 48 hours, off ECMO, and off vasoactive medications for at least 24 hours.
- Resting SpO2 ≥92% with stable oxygen requirements and able to complete study procedures in a seated or semi-recumbent position.
- Negative CAM/CAM-ICU assessment during the preceding 24 hours, with clear consciousness and ability to complete sleep and cognitive assessments.
- Stable trends in blood pressure, blood glucose, serum sodium, serum magnesium, and renal function; immunosuppressant concentrations considered acceptable by the transplant team.
- Mean RCSQ score <70 across two consecutive valid inpatient nights and baseline ISI score ≥8.
- Able to complete RCSQ, sleep diary, Lifesense HR6 monitoring, and 64-channel EEG assessments.
- Expected to remain hospitalized for at least 10 days and able to complete 10 stimulation sessions and the primary outcome assessment within 14 days.
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.
- Repeat lung transplantation, multiorgan transplantation, or current requirement for ECMO, mechanical ventilation, or vasoactive support.
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- Active delirium, encephalopathy, posterior reversible encephalopathy syndrome (PRES), central nervous system infection, new focal neurological deficit, or seizure within the previous 30 days.
- Suspected calcineurin-inhibitor neurotoxicity, uncontrolled hypertension, clinically significant hypomagnesemia, hyponatremia, hypoglycemia, or other metabolic abnormality that may lower the seizure threshold.
- Uncontrolled sepsis, active rejection requiring urgent intensified treatment, or rapidly deteriorating clinical status.
About this study
Official title: Low-Frequency Repetitive Transcranial Magnetic Stimulation Combined With 64-Channel Electroencephalography for In-Hospital Sleep Disturbance in Lung Transplant Recipients: 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 adult lung transplant recipients during early postoperative recovery.
A total of 152 participants with in-hospital sleep disturbance after first single- or double-lung transplantation 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 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, mood, cognitive and functional outcomes, 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 conducted in adult recipients of a first single- or double-lung transplantation. Eligible participants will be enrolled during postoperative days 7-21 after clinical stabilization and must have evidence of in-hospital sleep disturbance, defined by a mean Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 across two consecutive valid inpatient nights together with an Insomnia Severity Index (ISI) score of at least 8.
Participants will be randomized 1:1 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. The sham group will undergo matched procedures using a dedicated sham coil or validated active/sham masking module with the same target, positioning, rhythm, sound, duration, and interaction procedures but without intended therapeutic cortical stimulation.
Participants and outcome assessors will remain blinded to treatment allocation. Clinical study personnel and statistical personnel will also remain blinded as specified in the protocol; stimulation operators cannot be blinded because of device-operation requirements but will not participate in recruitment, 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. The RCSQ ranges from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare active and sham groups using an ANCOVA/linear-regression model adjusted for baseline RCSQ and prespecified randomization stratification factors.
Secondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, ISI and other sleep measures, pain and opioid exposure, delirium, cognitive function, anxiety, depressive symptoms, fatigue, health-related quality of life, hospital and transplant-related outcomes, treatment feasibility, and adverse events. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in spectral power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.
All participants will continue to receive standard post-transplant clinical care and standardized inpatient sleep-support measures. Necessary clinical treatment will take priority over study procedures, and the study intervention will not be used to delay treatment, rehabilitation, transfer, or discharge.
- Conditions
- Sleep Wake Disorders, Lung Transplantation
- Being tested
- Active Low-Frequency Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, In-Hospital Sleep Disturbance, Lung Transplant Recipients, Dorsolateral Prefrontal Cortex, Richards-Campbell Sleep Questionnaire, 64-Channel Electroencephalography
- Medical subject headings
- 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 during the same hospitalization. No more than one study stimulation session will be administered on the same calendar day.
Sham Repetitive Transcranial Magnetic StimulationDevice
Sham stimulation will be administered using a dedicated sham coil or validated active/sham masking module compatible with the locked study device. The 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 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 standard post-transplant 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 standard post-transplant care and 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; 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; 24-72 hours after the final stimulation session
EQ-5D-5L Health-Related Quality of Life
Health-related quality of life will be assessed using the Simplified Chinese version of the EQ-5D-5L. The China value-set utility index and EQ visual analog scale will be reported.
Measured: Baseline; 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 safety follow-up at postoperative Month 6
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 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Wake DisordersStudies 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
- Model description
- Participants will be randomized in a 1:1 ratio to active low-frequency rTMS or matched sham stimulation using a parallel-group design. Both groups will receive standard post-transplant care and the same inpatient sleep-support measures.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 152 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
- NCT07796425
- Sponsor's protocol ID
- TMS-SLEEP-LTx-01
- Acronym
- TMS-SLEEP-LTx
- 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 Lung Transplant Recipients: A Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07796425
- Acronym / sponsor ID
- TMS-SLEEP-LTx / TMS-SLEEP-LTx-01
- Conditions
- Sleep Wake Disorders, Lung Transplantation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, rTMS, In-Hospital Sleep Disturbance, Lung Transplant Recipients, Dorsolateral Prefrontal Cortex, Richards-Campbell Sleep Questionnaire, 64-Channel Electroencephalography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 Aug 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 adult lung transplant recipients during early postoperative recovery.
A total of 152 participants with in-hospital sleep disturbance after first single- or double-lung transplantation 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 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, mood, cognitive and functional outcomes, 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 conducted in adult recipients of a first single- or double-lung transplantation. Eligible participants will be enrolled during postoperative days 7-21 after clinical stabilization and must have evidence of in-hospital sleep disturbance, defined by a mean Richards-Campbell Sleep Questionnaire (RCSQ) score below 70 across two consecutive valid inpatient nights together with an Insomnia Severity Index (ISI) score of at least 8.
Participants will be randomized 1:1 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. The sham group will undergo matched procedures using a dedicated sham coil or validated active/sham masking module with the same target, positioning, rhythm, sound, duration, and interaction procedures but without intended therapeutic cortical stimulation.
Participants and outcome assessors will remain blinded to treatment allocation. Clinical study personnel and statistical personnel will also remain blinded as specified in the protocol; stimulation operators cannot be blinded because of device-operation requirements but will not participate in recruitment, 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. The RCSQ ranges from 0 to 100, with higher scores indicating better sleep. The primary analysis will compare active and sham groups using an ANCOVA/linear-regression model adjusted for baseline RCSQ and prespecified randomization stratification factors.
Secondary and exploratory outcomes include total sleep time measured using the Lifesense HR6 wearable device, ISI and other sleep measures, pain and opioid exposure, delirium, cognitive function, anxiety, depressive symptoms, fatigue, health-related quality of life, hospital and transplant-related outcomes, treatment feasibility, and adverse events. Resting-state 64-channel EEG and a prespecified TMS-EEG mechanistic substudy will explore changes in spectral power, alpha peak frequency, functional connectivity, network topology, and TMS-evoked cortical responses.
All participants will continue to receive standard post-transplant clinical care and standardized inpatient sleep-support measures. Necessary clinical treatment will take priority over study procedures, and the study intervention will not be used to delay treatment, rehabilitation, transfer, or discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to active low-frequency rTMS or matched sham stimulation using a parallel-group design. Both groups will receive standard post-transplant care and the same inpatient sleep-support measures.
| 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 standard post-transplant 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 standard post-transplant care and inpatient sleep-support measures as the active rTMS group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-70 years and able to provide independent written informed consent. First single- or double-lung transplantation. Postoperative day 7-21 at randomization; extubated for at least 48 hours, off ECMO, and off vasoactive medications for at least 24 hours.
- Resting SpO2 ≥92% with stable oxygen requirements and able to complete study procedures in a seated or semi-recumbent position.
- Negative CAM/CAM-ICU assessment during the preceding 24 hours, with clear consciousness and ability to complete sleep and cognitive assessments.
- Stable trends in blood pressure, blood glucose, serum sodium, serum magnesium, and renal function; immunosuppressant concentrations considered acceptable by the transplant team.
- Mean RCSQ score <70 across two consecutive valid inpatient nights and baseline ISI score ≥8.
Key exclusion criteria (9 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 during the same hospitalization. No more than one study stimulation session will be administered on the same calendar day. | 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 locked study device. The 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 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; 24-72 hours after the final stimulation session
Patient Health Questionnaire-9 Score
Time frame: Baseline; 24-72 hours after the final stimulation session
EQ-5D-5L Health-Related Quality of Life
Time frame: Baseline; 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 safety follow-up at postoperative Month 6
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 Sleep Wake Disorders and Lung Transplantation, 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 9 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.