Magnetic pulses to the brain may help lung transplant patients sleep

NCT ID NCT07796425

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether low-frequency repetitive transcranial magnetic stimulation (rTMS) can improve sleep quality in adults recovering from a lung transplant. Participants with sleep problems during their hospital stay will receive either active rTMS or a sham (inactive) treatment over 10 sessions. The study measures sleep quality using a questionnaire and wearable devices, and also tracks mood, pain, and brain activity. If effective, rTMS could offer a non-drug option to help these patients rest better during a critical recovery period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-frequency repetitive transcranial magnetic stimulation (rTMS) delivered to the left dorsolateral prefrontal cortex
What this could lead to
If it works, this could offer a drug-free way to improve sleep for lung transplant recipients during their hospital stay, potentially speeding recovery and reducing distress.
What could go wrong
This is a Phase 2 trial with a modest number of participants, so results may not apply to all patients. The treatment is non-invasive but may cause mild discomfort or headaches, and its effect on sleep is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 152 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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